понедельник, 25 апреля 2011 г.

Detection Of Mortality Clusters Associated With Highly Pathogenic Avian Influenza In Poultry: A Theoretical Analysis

Rapid detection of infectious disease outbreaks is often crucial for their effective control. One example is highly pathogenic avian influenza (HPAI) such as H5N1 in commercial poultry flocks.


There is no quantitative data, however, on how quickly the effects of HPAI infection in poultry flocks can be detected.


Here, we study, using an individual-based mathematical model, time to detection in chicken flocks. Detection is triggered when mortality, food or water intake or egg production in layers pass recommended thresholds suggested from the experience of past HPAI outbreaks.


We suggest a new threshold for caged flocks-the cage mortality detection threshold-as a more sensitive threshold than current ones. Time to detection is shown to depend nonlinearly on R0 and is particularly sensitive for R0!10.


It also depends logarithmically on flock size and number of birds per cage. We also examine how many false alarms occur in uninfected flocks when we vary detection thresholds owing to background mortality.


Journal of the Royal Society Interface


Journal of the Royal Society Interface is the Society's cross-disciplinary publication promoting research at the interface between the physical and life sciences. It offers rapidity, visibility and high-quality peer review and is ranked fourth in JCR'S multidisciplinary category.


Journal of the Royal Society Interface

Can The U.S. Afford A Shortage Of Respirator Masks To Fight Flu Pandemic?

The Coalition for Breathing Safety, a group of U.S. respirator manufacturers, warned of a shortage of N95 masks, a crucial component of the U.S. government's pandemic emergency
response plans. A World Bank report released this week projected the global
economic impact of an avian flu pandemic to be as much as two trillion
dollars, underscoring concerns over the devastating potential of an
epidemic in the United States.



The Coalition for Breathing Safety issued the following statement
regarding the report:


"The World Bank study demonstrates that the avian flu threat has by no
means diminished. U.S. emergency planners and first responders will need
every weapon at their disposal to control the disease if it hits our
shores, including vast stocks of N95 respirators, which are key to the
government's strategy for 'social distancing.' If we fail to meet this
challenge, we run the risk of multiplying the social costs of a pandemic.


"Both public and private sector health experts have concluded that the
first line of defense if avian flu begins infecting humans, 'social
distancing,' depends on access to respirators approved by the National
Institute for Occupational Safety and Health (NIOSH) if it is to succeed.


"Without federal protection from thousands of frivolous silica and
asbestos lawsuits filed against respirator manufacturers, U.S. mask
production capacity may fall well short of meeting demand for N95 masks. In
2004 alone, U.S. respirator manufacturers spent 90% of net income from
respirator sales on litigation costs.


"There are some larger manufacturers who are ramping up N95 mask
production in the U.S. However, members of our Coalition, representing half
of N95 mask production capacity in the U.S., cannot invest in additional
U.S. capacity because of the deluge of lawsuits.


"U.S. production capacity is critical because during the SARS epidemic,
countries around the world embargoed all exports of respirator masks just
as demand skyrocketed.


"NIOSH tightly regulates the respirator industry by setting strict
design standards, conducting tests to ensure they are met, and approving
each and every respirator model as well as the warning labels that
accompany the product. Trial lawyers have included respirator manufacturers
in thousands of silica and asbestos lawsuits claiming defective mask design
or failure to warn users -- despite the fact that manufacturers cannot
affect how or when the respirators are used."


The Coalition for Breathing Safety supports bi-partisan legislation
introduced by Senators John Cornyn (RTX) and Ben Nelson (D-NE) in the
Senate (S. 1406) and Representatives Bill Shuster (R-PA) and Tim Holden
(D-PA) in the House (H.R. 2357) that would preempt lawsuits claiming
defective design or insufficient warning if a respirator is NIOSH approved.


The Coalition for Breathing Safety was formed in 2004 to ensure that
millions of emergency responders, workers and citizens across the globe
continue to have access to respiratory safety products.


Coalition for Breathing Safety

breathingsafety/index.htm

CytoGenix, Inc. Initiates Ferret Testing Expecting Positive Results For Avian Flu Vaccine Study

CytoGenix, Inc. (Pink Sheets:CYGX) announced that it has initiated the process of testing CytoGenix's novel liner DNA technology on ferrets, with the expectations of a positive result, furthering the development of the vaccine candidate.


"I fully expect the same if not better results in this new round of testing than that of our mouse tests, expecting that the end result will be a significant benefit to the shareholders of CytoGenix."


CytoGenix previously reported positive results of an animal study where mice were immunized with CYDBA507, the CytoGenix avian influenza vaccine candidate, which protected against lethal challenge with avian influenza virus. CYDBA507 is built on CytoGenix's synDNA platform and expresses influenza virus type A/H5N1 HA and NA proteins. The ability of CYDBA507 to express HA and NA proteins in human cells was confirmed in laboratory studies. The CYDBA507 was shown to be as high as 95% effective in some tests.


The emergence of highly pathogenic avian influenza virus type A/H5N1 in domestic poultry and the increasing number of human cases indicates a significant threat to public health because of the potential for pandemic spread of this virus. CytoGenix is developing CYDBA507 for both human use and commercial poultry farming. The development of CYDBA507 as a low cost and more effective vaccine process than other vaccine providers, makes CytoGenix's product the preferred vaccine.


Lex Cowsert, PhD, CEO of CYGX stated, "Based on successful results of our prior testing, we fully expect that the results of our ferret test will clearly demonstrate the superior quality and effectiveness of the CytoGenix product line. The expected results of our testing will further demonstrate the unprecedented breakthrough technology in the field of DNA vaccines, with the expanding demand for effective bird flu and other vaccines, we feel confident that these results will convert to significant revenue for CytoGenix."


Cy Stein, MD, PhD, Chairman of the Board of Directors of CYGX stated, "I fully expect the same if not better results in this new round of testing than that of our mouse tests, expecting that the end result will be a significant benefit to the shareholders of CytoGenix."


Source:

CytoGenix, Inc.

Norfolk Poultry Worker Contracts H7N3 Bird Flu Strain, UK

One of the poultry workers who worked at Witford Lodge Farm in Norfolk, England, has become infected with the H7N3 Bird Flu virus strain. He is not in hospital, as H7 does not make humans very ill, but he has conjunctivitis. He or she had been in close physical contact with infected birds. The worker does not want to be named. Antiviral Tamiflu was administered to poultry workers on the farm as a precautionary measure.


H7N3 infected birds had been found in the Norfolk farm a few days ago. Laboratory tests confirmed the presence of H7N3.


The H7N3 strain was last found in the UK in 1979.


The H5N1 strain is the dangerous one for humans, not the H7N3 one. It is not easily transmitted from bird to human, or from human to human. Authorities in the UK say the worker has no other symptoms, except for conjunctivitis. The Health Protection Agency said the H7N3 outbreak is not a danger to the public.


People who work in the infected farm have been offered a flu shot. The bird flu virus, if it infects a human who has normal flu, has the opportunity to exchange genetic information with the normal flu virus and mutate - and become transmissible from human to human. A flu shot would reduce the chances of a person ever getting normal flu in the first place.


35,000 chickens will be culled in the infected farm and a 1 kilometre exclusion zone has been placed.


Written by:




View drug information on Tamiflu capsule.



UGA Study Identifies North American Wild Bird Species That Could Transmit Bird Flu

University of Georgia researchers have found that the common wood duck and laughing gull are very susceptible to highly pathogenic H5N1 avian influenza viruses and have the potential to transmit them.



Their finding, published in the November issue of the journal Emerging Infectious Diseases, demonstrates that different species of North American birds would respond very differently if infected with these viruses. David Stallknecht, associate professor in the department of population health at the UGA College of Veterinary Medicine and co-author of the study, said knowing which species are likely to be affected by highly pathogenic H5N1 viruses is a vital component of efforts to quickly detect the disease should it arrive in North America.



"If you're looking for highly pathogenic H5N1 in wild birds, it would really pay to investigate any wood duck deaths because they seem to be highly susceptible, as are laughing gulls," said Stallknecht, a member of the UGA Biomedical and Health Sciences Institute. "It was also very interesting that in some species that you normally think of as influenza reservoirs - the mallard, for instance - the duration and extent of viral shedding is relatively low. This may be good news since it suggests that highly pathogenic H5N1 may have a difficult time surviving in North American wild birds even if it did arrive here."



Working under controlled conditions in an airtight biosecurity lab at the USDA Agricultural Research Service's Southeast Poultry Research Laboratory, the researchers determined how much of the virus was shed in the feces and through the respiratory system of several species of wild birds. The work was jointly funded by the United States Poultry and Egg Association, the Morris Animal Foundation and the USDA.



"We chose birds that, because of their behavior or habitat utilization, are most likely to transmit the virus or bring the virus here to North America," said lead author and doctoral student Dr. Justin Brown.



The species studied were: Mallards, which are often infected with commonly circulating, low-pathogenic avian influenza viruses in North America and Eurasia; Northern pintails and blue-winged teal, which migrate long distances between continents; redheads, a diving species; and wood ducks, which breed in Northern and Southern areas of the United States. The laughing gull is a common coastal species ranging from the Southern Atlantic to the Gulf Coast.



Stallknecht explained that in low-pathogenic avian influenza, most of the virus is shed in the feces of birds. The virus then spreads as other birds drink from contaminated water. The study found that in highly pathogenic H5N1 avian influenza, however, the birds shed most of the virus through their respiratory tract.



Stallknecht said that with this knowledge, scientists can more effectively detect the virus in live birds by swabbing the birds' mouths and throats.
















"Doing avian influenza surveillance is pretty tricky because there are a lot of species differences and there are also seasonal differences," he said. "So you've got to pick the right species at the right time and you've got to collect the right samples."



In a related study scheduled to be published in December issue of the journal Avian Diseases, the researchers have quantified how long the virus persists in water samples. They found that highly pathogenic H5N1 avian influenza viruses don't persist as long as common low-pathogenicity strains. In some cases, persistence times were reduced by more than 70%. This could affect transmission and supports the idea that these viruses may not have much of chance of becoming established in North America.



Stallknecht said the finding is encouraging, but cautions that it's difficult to put it into context without results from a study his team is currently working on that will assess the minimum amount of virus it takes to infect a bird.



This month the researchers also received the first $875,000 of a planned three-year grant totaling $2.6 million from the Centers for Disease Control and Prevention. The grant will be used for an ambitious project that will take a broad look at the possibility of human contact with avian influenza viruses.



In the first phase of the project, the researchers will examine the prevalence, persistence and distribution of the viruses in various environments. In the next phase, they'll work with state public health departments to determine the groups of people who -by virtue of their occupation or recreational activities - are likely to come into contact with the viruses. The researchers will then assess the ability of low-pathogenic avian influenza viruses to infect mammals so that the risk of human contact can be put into perspective.



"With this information, public health officials will be able to better understand the human health risks associated with both low-pathogenic and highly pathogenic avian influenza viruses in both domestic and wild bird populations," Stallknecht said. "Many of these potential risks are not very well understood or even defined, and it is possible that they could be very effectively controlled with simple preventive measures."






Contact: Sam Fahmy


University of Georgia

Who Should Get Pandemic Vaccine First? The Strong, The Weak, The Young Or The Elderly?

Public health experts are finding it hard to agree who should get the flu pandemic vaccine first? Should we protect the most vulnerable, such as the elderly and people who suffer from asthma, diabetes and weakened immune systems? Or should we focus on those who are most likely to recover?


It is unlikely an effective vaccine would be available for more than 10% or 20% of a nation's population during the first year of a pandemic. Therefore, immunizing everyone would be impossible.


According to some American researchers, led by Ezekiel Emanuel, National Institutes of Health (NIH), young people should be given priority over the elderly and everyone else. You can read their report in the journal Science.


If you don't vaccinate health staff first, I wonder how many would not turn up for work. Health workers are the most likely to be exposed to infection. How would their motivation be affected if they were not immediately given a vaccine?


Ezekiel Emanuel's report says "With limited vaccine supply, uncertainty over who will be at highest risk of infection and complications, and questions about which historic pandemic experience is most applicable, society faces a fundamental ethical dilemma. Who should get the vaccine first?"


The report states that throughout much of history the focus has usually been to try to save those who have the highest chance of recovering as this saves the most lives.


Ezekiel Emanuel and team believe priority should be given to those who have not yet experienced various stages of life, such as adulthood, middle and old age - they should be given the opportunity. They believe there is great value to being able to experience each stage of life, from childhood, young adulthood, then to go on and pursue a career and raise a family, and finally to grow old. It is always more tragic when a child loses his/her life because that person has not had the opportunity to experience life's milestones.


The NIH team sees the reason for giving children priority as an ethical one, rather than a way of saving the most lives.


Government departments and public health experts will need to have a plan in place. Personally, I cannot see how you could exclude health care professionals and support staff from the top of the list.


Written by:





Government Helps Protect Backyard Birds From Avian Influenza

A national campaign, led by the Canadian Food Inspection Agency (CFIA), is underway to promote Bird Health Basics-simple steps that owners of backyard flocks and pet birds can take to help protect their birds from dangerous diseases, such as avian influenza and exotic Newcastle disease.


The CFIA, in collaboration with provincial governments, is hosting a series of educational meetings to provide bird owners with information about how to help prevent and detect avian diseases, and what to expect if an outbreak occurs. The first of these sessions will be held in Nova Scotia, Ontario, and British Columbia in early 2008. The CFIA will hold additional sessions in other regions later in the year.


The Bird Health Basics campaign also includes a 2008 calendar, which provides monthly tips on biosecurity-steps that help prevent the spread of viruses and other disease-causing agents. The CFIA has also produced an animated biosecurity video, which takes a light, yet informative approach to disease prevention. All Bird Health Basics materials can be obtained by calling the CFIA at 1-800-442-2342 or by visiting inspection.gc.ca.


Beyond the campaign, the CFIA is providing support to stimulate the development of on-farm biosecurity technologies of interest to the Canadian poultry sector. A total of $3 million over five years is being provided to applicants for avian biosecurity-related projects.


Information about the full range of Government activities to help prevent, detect and respond to avian influenza outbreaks is available at inspection.gc.ca.

Canadian Food Inspection Agency.

Twelve More Suspected Bird Flu Cases In Iraq

Twelve more people are suspected of being infected with the H5N1 bird flu strain in Northern Iraq, say authorities there. The affected area is Kurdistan, near the Turkish border.


Authorities are starting to cull poultry and birds in the area. They say they have so far killed over half a million birds - about half of all farm birds in areas north of Sulaimaniya by Lake Dukan, and in Raniya.


Kurdish Deputy Prime Minister, Imad Ahmed said the total number of humans suspected of being infected with bird flu (H5N1) now stands at twelve.



A girl of 15 and her uncle died a few days ago in northern Iraq - it was confirmed they both died as a result of infection of the H5N1 bird flu virus strain. A 54 year old woman is critically ill in hospital with probably bird flu.


Iraq is now the seventh country to report human cases of bird flu since 2003 - the first country was Viet Nam.


Written by:





Sharp's Plasmacluster Ions Effectively Deactivates H5N1 Avian Influenza Virus

Tokyo (JCNN) - Sharp announced on June 6 that it has verified the effectiveness of Plasmacluster Ions, its proprietary air-purifying technology, in collaboration with Retroscreen Virology, Ltd, a UK contract virology research company.


Their recent research showed that Plasmacluster Ions effectively deactivates H5N1 avian influenza virus, specifically, lowering its activity level by 99%. This is the first air-purifying technology that has demonstrated the efficacy against H5N1 virus.


Developed in 2000, Plasmacluster Ions can sanitize the air by releasing both positive and negative ions. Retroscreen Virology, which is founded by University of London School of Medicine & Dentistry Professor John S. Oxford in 1989, has a well established track record in virological research and clinical trials.


View Sharp Corporation company profile here


Copyright © 2005 JCNN. All rights reserved. A division of Japan Corporate News Network KK.

Bird Flu in Viet Nam and Cambodia

The Ministry of Health in Viet Nam has confirmed three additional cases of human infection with H5N1 avian influenza. The
cases concern a 5-year-old boy from the central province of Quang Binh, a 17-year-old girl from the northern province of Nam
Dinh, and a 40-year-old woman from the northern province of Quang Ninh. The 17-year-old girl has died.


An earlier case has also been confirmed. These recently confirmed cases bring the total in Viet Nam since mid-December to 28.



WHO is aware of reports of suspected H5 avian influenza infection in five members of a family who are presently hospitalized
in the northern port city of Haiphong. These cases, which include the parents and their three young daughters, are undergoing
further investigation following initial tests indicating infection with the H5 subtype of avian influenza. Reports indicate
outbreaks of avian influenza in poultry in the vicinity. Field investigation of this family cluster is under way.


The current outbreak of human cases in Viet Nam has included several clusters, mostly in family members, of cases closely
related in time and place. Thorough investigation of all such clusters is essential to determine possible changes in the
behaviour of the virus and thus support assessment of the risk of an influenza pandemic.


There is currently no evidence that the H5N1 virus is spreading easily from person to person. Rapid sharing with WHO of
viruses from recent clusters of cases has become increasingly important. Analysis can determine whether any significant
changes in the virus have taken place and provide further support for risk assessment.


Several media reports have recently covered rumours of a large outbreak of influenza-like illness in Quang Binh Province. The
outbreak is presently under investigation by provincial and central health authorities. Samples have been taken for testing,
and WHO is awaiting the results. The number of cases with influenza-like illness appears much smaller than initially reported
by the media.


Cambodia


The Ministry of Health in Cambodia has today confirmed the country's second human case of avian influenza.


The 28-year-old man, from Kampot Province, developed symptoms on 17 March and was hospitalized in Phnom Penh on 21 March. He
died on 22 March. The same day, laboratory tests by the Pasteur Institute in Phnom Penh confirmed that the man was infected
with H5 avian influenza virus. The Cambodian government immediately launched an investigation to search for possible
additional cases and identify possible sources of exposure to the virus. The investigation team, which is continuing its work
in Kampot Province, includes Cambodian Ministry of Health and Ministry of Agricultural officials joined by staff from the WHO
country office and the Pasteur Institute in Phnom Penh. FAO is assisting the investigation of animal disease. Numerous deaths
among chickens in the area have been reported and samples taken from sick chickens have tested positive for avian influenza.
The results from the investigation indicate the deceased man had contact with sick poultry. An 18 year-old boy initially
identified as an additional suspected case has tested negative for the avian influenza virus. Samples taken from twenty seven
other people, including family contacts of the confirmed case and Phnom Penh medical staff involved in his care, have all
tested negative for H5 avian influenza infection. Results from a further six people from Kampot Province have also tested
negative for H5 influenza virus.


Cambodia's previous case, a 25-year-old woman who died in late January, was also from Kampot Province but lived in another
district.


The majority of poultry in Cambodia are raised in small backyard flocks in rural areas, making surveillance for outbreaks
especially challenging. A campaign to educate rural populations about the dangers of contact with dead or diseased poultry is
being undertaken by the government, with support from WHO.


who.int

Juvaris BioTherapeutics Announces Cooperative Research And Development Agreement With The Centers For Disease Control And Prevention

Juvaris BioTherapeutics,
Inc. announced that The Centers for Disease Control and Prevention
and Juvaris BioTherapeutics, Inc. have entered into a Cooperative Research
and Development Agreement (CRADA) for the evaluation of a JVRS-100
adjuvanted H5N1 pandemic influenza vaccine. The ability of JVRS-100 to aid
in the induction of a protective antibody response to the H5N1 vaccine at
low doses of vaccine will be confirmed. This collaborative study will
determine if the use of the Juvaris JVRS-100 adjuvant will extend the
limited supply of H5N1 vaccines in the event of a pandemic.


In preparation for the possibility of an influenza pandemic caused by
an H5N1 avian influenza virus that has obtained the ability to be easily
transmitted from person to person, several strains of H5N1 viruses have
been used to prepare killed-virus vaccines. Vaccine trials in people
testing the immunogenicity of these pre-pandemic vaccines have shown that
high vaccine doses are required to produce an antibody response that is
believed to be protective. In order to lower the dose of vaccine and extend
the supply of available vaccine, a number of immune boosters known as
adjuvants are being tested.



"Although the principal commercial value of JVRS-100 will be as a
mono-immunotherapy, we are pleased to enter into this CRADA with CDC for
testing of the JVRS-100 as an adjuvant for potential extension of the
current supply of H5N1 vaccine," said Martin D. Cleary, Co-founder,
President and CEO of Juvaris. "In preclinical studies using seasonal
influenza vaccine our adjuvant can decrease the amount of vaccine necessary
to induce protective antibody immunity up to fifty-fold, which would be
beneficial in case of limited vaccine supply during an influenza pandemic.
Furthermore, preclinical experiments with inactivated virus have shown
greater cross-protection when our adjuvant is used."



About Juvaris



Juvaris BioTherapeutics was created in 2003 to develop an
immunotherapeutic product platform for the treatment of infectious diseases
and cancers using lipid-DNA complexes. Cationic lipids are formulated with
non-coding DNA (plasmid) to create the JuvImmune Immunostimulant, a
lipid-DNA complex, which as a single product will have utility in multiple
infectious disease and cancer applications. The JuvImmune product has been
shown to be at least 50-times more potent at triggering innate immune
activation and interferon release than current immune stimulants.



When combined with disease-specific antigens, the technology creates
JuvaVax vaccines capable of activating substantial antibody- and
cell-mediated immune responses, particularly induction of cytotoxic T
lymphocytes (CTL). Immunological responses elicited by the lipid-DNA
complexes have been successfully demonstrated in both prophylactic and
therapeutic settings in a variety of mammals including rodents, rabbits,
cats, dogs and non-human primates. This platform provides the opportunity
to develop many disease-specific immunotherapy products, for which there
are significant unmet medical needs.



The Company recently completed a Series A financing with Kleiner
Perkins Caufield & Byers as the sole investor. It plans to start up to four
clinical studies in 2008. The first will be a prophylactic vaccine for
Influenza A, the second a therapy for chronic Hepatitis B, the third for
chronic Hepatitis C and a fourth for Acute Myelogenous Leukemia (AML).


Juvaris BioTherapeutics, Inc.

juvaris

More Cases of Patients with Bird Flu in Viet Nam

The Ministry of Health in Viet Nam has confirmed an additional four cases of human infection with H5N1 avian influenza.



Details about these four cases are as follows:


-- A 21-year-old man from Thai Binh Province. He developed symptoms on 14 February and was admitted to hospital on 20
February.


-- His 14-year-old sister, also from Thai Binh Province. She developed symptoms on 21 February and was hospitalized the
following day.


-- A 69-year-old man, also from Thai Binh Province. He developed symptoms on 19 February, was admitted to hospital the same
day, and died on 23 February.


-- A 35-year-old woman from Hanoi. She developed symptoms on 18 February and was hospitalized on 24 February.


WHO continues to work closely with the Vietnamese Ministry of Health to further investigate additional cases which may have
occurred since 2 February. WHO will update its cumulative list of confirmed cases accordingly.


Earlier this year, staff from WHO, Japan's National Institute of Infectious Diseases in Tokyo, and Centers for Disease
Control and Prevention, Atlanta, Georgia, USA, began working with health authorities in Viet Nam to improve the sensitivity
and reliability of laboratory diagnostic tests. This activity, which aimed to upgrade laboratory capacity and included a
training component, involved the retesting in Tokyo of specimens from several persons initially classified in Viet Nam in
January as negative for H5N1 infection. Retesting detected H5N1 in specimens from seven persons. WHO is awaiting further
details about these cases, including outcomes. Upon receipt of this information, WHO will also include these cases in the
cumulative total for Viet Nam.


One additional case in Viet Nam, dating back to February 2004, has been identified retrospectively from specimens stored as
part of a study of encephalitis (see the New England Journal of Medicine,
2005, 352:686-691). H5N1 infection, which was not considered in the diagnosis of this fatal case, was identified in
November 2004 when specimens were submitted to a battery of tests. Specimens collected from other patients in this study are
now being systematically tested for possible H5N1 infection.


Information on new cases is of greatest concern and WHO continues to gather as much data as possible on each new case. Such
data are urgently needed at a time when many countries are intensifying their pandemic preparedness activities.


SOURCE: who.int

U OF M Awarded $22.5 Million NIH Contract To Study Avian Influenza

The National Institute of Allergy and Infectious Disease (NIAID), part of the National Institutes of Health (NIH), today named the University of Minnesota as one of six sites across the country that will establish a Center of Excellence for Influenza Research and Surveillance.



The Minnesota NIH/NIAID Center of Excellence for Influenza Research and Surveillance (MCEIRS) will receive $22.5 million over seven years to focus on disease and virologic surveillance of avian influenza viruses, providing the federal government with useful information and public health strategies for controlling the impact of an influenza pandemic.



"The Center of Excellence established at the U of M will work to rapidly identify and characterize influenza viruses that have pandemic potential by monitoring domestic and international wild bird, poultry, and swine populations," said Marguerite Pappaioanou, D.V.M., Ph.D., principal investigator and professor of infectious disease and epidemiology at the University of Minnesota School of Public Health. "The center will be prepared to respond to research and public health needs in a time of increasing concern over the possibility of pandemic flu."



The MCEIRS will perform animal flu surveillance in eight countries and multiple states. Domestic research will include: monitoring wild birds in U.S. wetlands; identifying low pathologic influenza strains in Minnesota poultry; characterizing swine viruses in animal populations from Minnesota to North Carolina; and conducting virologic surveillance in live bird markets in the Midwest and Northeast. Internationally, the center will conduct avian influenza surveillance of people, poultry, pigs, dogs, cats, and wild birds in rural Thailand; wild waterfowl in Vietnam; wild bird populations in Laos; and commercial poultry operations in other Asian countries.



The majority of diagnostic testing and virus characterization will occur at the University of Minnesota College of Veterinary Medicine's Veterinary Diagnostic Laboratory and Genomic Center. Faculty will obtain and characterize multiple types of influenza viruses, adding to the world database that supports research on how humans become infected with influenza, what factors influence the severity of illness, and the development of vaccines and antiviral medications.



"This award showcases the strength of the University of Minnesota's interdisciplinary corridor of research in infectious disease," said Frank B. Cerra, M.D., the University's Senior Vice President of Health Sciences. "The University will help pave the way in influenza research and contribute valuable and influential information to the federal government regarding pandemic preparedness."



Together with University strengths in veterinary medicine, public health, and supercomputing, the MCEIRS' external partners include: Chulalongkorn University in Thailand; Southeastern Cooperative Wildlife Disease Study at the University of Georgia; the Wildlife Conservation Society; the U.S. Geological Survey National Wildlife Health Center; Cargill, Inc.; the Minnesota State Board of Animal Health; the Minnesota Department of Agriculture; and the Minnesota Department of Health.



Key advisors to the center will be Michael Osterholm, Ph.D., M.P.H., director of the Center for Infectious Disease Research and Policy at the University of Minnesota School of Public Health; David A. Halverson, D.V.M., professor of veterinary and biomedical sciences at the University of Minnesota College of Veterinary Medicine; and Vivek Kapur, Ph.D., B.V.Sc., director of the Advanced Genetic Analysis Center and professor of veterinary pathology at the University of Minnesota College of Veterinary Medicine.



In addition to the University of Minnesota, other Centers of Excellence for Influenza Research and Surveillance will be located at Emory University, Mount Sinai School of Medicine, the University of Rochester, the University of California at Los Angeles, and St. Jude Children's Research Hospital.







Contact: Liz Wulderk

University of Minnesota

GlaxoSmithKline Receives New HHS Order For H5N1 Bulk Antigen

GlaxoSmithKline (NYSE:
GSK), one of the world's largest vaccine manufacturers, today announced
that HHS has placed another order to purchase bulk H5N1 antigen for the US
national stockpile of pre-pandemic vaccines. The company also announced the
start of the first North American pre-pandemic vaccine trials in the
company's global pre-pandemic influenza program.



HHS Order



The company has received a second task order for 22.5 million doses of
15 mcg H5N1 bulk vaccine antigen from the U.S. Department of Health and
Human Services (HHS) under a contract [HHS100200700027I] awarded in
November 2007. This is in addition to the 5 million doses of H5N1 clade 2
bulk antigen at 15 mcg HA/dose ordered in November 2006. The additional
task order procures an additional 9 million doses of H5N1 clade 2 bulk
vaccine produced in the 2006 manufacturing campaign and 13.5 million doses
of H5N1 clade 2 bulk vaccine expected to be produced in the 2007
manufacturing campaign.



Under the terms of the contract, GSK will manufacture the bulk vaccine
product at the GSK manufacturing site in Ste. Foy, Canada and store bulk
H5N1 antigen at the GSK site in Marietta, PA. Terms of the contract also
state that GSK may be directed by HHS to formulate this bulk antigen at
some point in the future. Additionally, HHS also has the option to purchase
pre-pandemic vaccines together with one of GSK's proprietary adjuvant
systems, which could mean that less antigen would be needed per dose to
achieve a protective immune response. Funding for this contract is provided
through the Office of Biomedical Advanced Research and Development
Authority (BARDA) in the Assistant Secretary for Preparedness and Response
(ASPR).



David Stout, President, Pharmaceutical Operations, GlaxoSmithKline
said: "We applaud the US government's proactive steps in protecting
American citizens against this potential public health threat. We are
committed to helping governments and public health officials around the
world effectively respond to the global threat of a flu pandemic and we are
pleased to be working with the US government in its preparedness efforts."



Initiation of H5N1 clinical trials



Today also marked the start of the first pre-pandemic vaccine trials
involving GSK's proprietary adjuvanted H5N1 vaccine in North America. The
vaccine used in these trials will be produced at the company's North
American manufacturing facility in Quebec, Canada. These U.S. studies are
supported by a contract [HHS100200700029C] from BARDA/ASPR/HHS awarded in
January 2007 for the advanced development of antigen-sparing pandemic
influenza vaccines towards U.S.-licensure with a commitment to U.S.
production of 150 million doses of pandemic vaccine within six months of a
pandemic onset.
















The trials highlight the company's continuing commitment to its global
pre-pandemic influenza vaccine development program. Data from earlier
European studies, using a pre-pandemic vaccine produced at GSK's Dresden,
Germany facility, showed that the influenza candidate vaccine may be able
to induce immune responses that might protect against different strains of
H5N1.



GSK's first North American pre-pandemic vaccine trial will be a Phase
I/II study that evaluates its H5N1 antigen alone and in combination with
one of its proprietary Adjuvant Systems, in 675 subjects. This Phase I/II
study is expected to lead into a larger, multi-center, Phase III trial -
one of the largest in North America - which is expected to enroll
approximately 4,400 subjects later in 2007.



Ripley Ballou, Vice President of Clinical Development for Flu at
GlaxoSmithKline said: "The goal of our North American clinical development
program is to establish GSK's second manufacturing facility as a source for
H5N1 vaccine, further strengthening our efforts to support governments'
pandemic preparedness strategies. The initiation of these trials
underscores the importance of GSK's $2 billion investment in 2005 to create
a new influenza vaccine infrastructure in North America."



This Phase I/II study, which will be conducted in seven states in the
United States and two provinces in Canada, is an observer-blind,
randomized, active-controlled trial that will evaluate the safety and
immunogenicity of two consecutive doses of H5N1 pre-pandemic vaccine. The
vaccine containing H5N1 antigen alone will be evaluated against a vaccine
containing H5N1 antigen in combination with the Adjuvant System, in 675
adult volunteers aged between 18 and 64 years. Results from this study will
be available in early 2008.



GSK is actively pursuing research into ways to make vaccines more
effective through the use of Adjuvant Systems, combinations of compounds
that are designed to enhance a vaccine's ability to elicit a strong,
durable and protective immune response in the human body.



GSK's candidate pre-pandemic split antigen H5N1 vaccine induced a
substantial level of cross-reactive immune response against a 'drifted'
strain of H5N1 virus in a clinical trial conducted in 2006. A drifted
strain is one that has undergone evolution in its protective antigens
relative to the vaccine; the process of 'drift' is the same phenomenon that
allows new strains of seasonal flu virus to circulate and cause disease
year after year. This GSK candidate vaccine was accepted for review by the
Committee for Medicinal Products for Human Use (CHMP) in Europe in January
2007.



In 2005, GSK invested approximately $2 billion in expanding its vaccine
manufacturing and development activities in North America, primarily
through the acquisition of the Canadian company, ID Biomedical (IDB). GSK's
FluLaval(R) and Fluviral(R) seasonal influenza vaccines for use in North
America and Canada are currently produced in IDB's former facility in
Quebec, Canada and Dresden, Germany respectively. Additionally, GSK is
modernizing its facility in Marietta, PA, to develop and manufacture
cell-culture based seasonal and pandemic influenza vaccines. These cell
culture vaccine candidates are not approved in the US.



About GlaxoSmithKline



GSK is one of the world's leading research-based pharmaceutical and
health care companies. GSK is committed to improving the quality of human
life by enabling people to do more, feel better and live longer. For
company information visit: gsk.



About GSK Biologicals



GSK Biologicals, based in Rixensart, Belgium, is the vaccine division
of GlaxoSmithKline. As one of the world's leading vaccine manufacturers,
GSK Biologicals employs more than 1,500 scientists devoted to discovering
new vaccines and developing more cost-effective and convenient combination
products to prevent infections that cause serious medical problems.



FluLaval and Fluviral are registered trade marks of the GlaxoSmithKline
group of companies.


GlaxoSmithKline

gsk

As 5th Anniversary Of 9/11 Approaches, Public Confidence In Government Drops

On the eve of the fifth anniversary of the September 11th attacks, the American public's confidence in the ability of the U.S government to protect them from terrorism, or respond to disasters or emergencies, has dropped to startling new lows, according to a new study commissioned by the National Center for Disaster Preparedness (NCDP) at Columbia University's Mailman School of Public Health and The Children's Health Fund (CHF).



The survey also showed that the majority of the American public lacks confidence in the nation's health care system to be able to respond effectively to biological, chemical or nuclear attacks or a major outbreak of the bird flu.



The survey separately polled Louisiana and Mississippi residents affected by Hurricane Katrina on preparedness issues and found them more ready for another natural disaster than the rest of America. New York residents, a third component of the poll, were found to be less prepared.



The survey was conducted in July and August by the Marist College Institute for Public Opinion as a follow-up to polls conducted annually since 2002 to identify trends and public attitudes related to the terrorist attacks of September 11 and disaster preparedness.



PUBLIC CONFIDENCE DROPS IN ALL AREAS



In the national survey, fewer than half - just 44 percent - said they were confident the government could protect them from a terrorist attack. That figure is a drop from 2005 (49 percent) and significantly less than 2003 (64 percent).



Only about one-third said they believed the government could protect public transportation (36 percent), U.S. shipping ports (36 percent), or U.S. borders (31 percent) from terrorism.



The nation's health care system also got a huge no-confidence vote in the survey. Just over one-in-four of those polled (28 percent) said they felt the health care system was ready to respond to terrorist attacks, be they biological, chemical or nuclear. That was a drop from 2005 and 2004 (39 percent for both) and nearly half the number from 2002 (53 percent). Confidence was even lower when it came to a health crisis not related to terrorism. Only 23 percent said the health care system was ready to respond effectively to a bird flu pandemic.



Additionally, far fewer Americans (38 percent) expressed confidence in Department of Homeland Security Secretary Michael Chertoff to do his job than they previously expressed for his predecessor, Tom Ridge (65 percent in 2004).



"These results show that the public is deeply concerned about the lack of readiness on a national and regional level for any large-scale disaster," said Irwin Redlener, M.D., director of the Mailman School's NCDP and president of CHF. Dr. Redlener is also the author of the new book, "Americans at Risk: Why We Are Not Prepared for Megadisasters and What We Can Do Now," published by Knopf, which looks at how unprepared the nation is for future terrorist attacks and disasters. "If the public does not believe the government or the medical infrastructure is ready to deal with terrorism and natural disasters, they will not trust the directives and guidance given by those in charge. This can potentially mean chaos in emergencies. That is why we need significant changes in how our leaders address preparedness and communicate with the public."
















Senator Hillary Rodham Clinton commented, "In this post-9/11, post-Katrina world, when we face threats of terrorism, pandemic influenza, and other naturally occurring disasters and disease outbreaks, there is clearly so much more that needs to be done before we are prepared to face these threats. However, the public deserves to have confidence that their leaders are doing everything in their power to take the steps necessary to keep our families and our communities safe. We owe our citizens nothing less."



DESPITE INCREASED FEARS, PUBLIC IS LESS PREPARED



Overall, the American public is more concerned about terrorism, but less prepared than ever for it. About 82 percent of the public now feel that the United States will experience more terror attacks, up from 78 percent in 2005 and 76 percent in 2004 and 2003. Across the country, the concern is relatively equal. Despite this overwhelming concern, no more than 33% of Americans are even minimally prepared for major terror-related disasters.



In Louisiana and Mississippi, 68 percent of those polled said they were prepared for another natural disaster or emergency weather event. In fact, 77 percent said they were concerned they may be facing another disaster or emergency soon. However in New York, only 45 percent said they were ready for natural disasters and emergencies. When it came to terrorist attacks, about a third of all Americans (33 percent) and New Yorkers (34 percent) said they were ready.



The poll also showed that there are significant racial disparities in how Americans view the government and preparedness. African-Americans held far less favorable views on the topics covered, compared to Whites and Latinos. Just 36 percent had confidence in the government to protect them from terrorist attacks, as opposed to 44 percent for Whites and 49 percent for Latinos. Their confidence in government to respond to natural disasters was 43 percent, with Whites at 55 percent and Latinos at 62 percent.







Additional details on the survey are available at ncdp.mailman/. The full survey results are available upon request.



The national survey was conducted July 19 to August 7, with 1,207 adults interviewed. The survey has a margin of error of +/-3 percent. The Louisiana/Mississippi survey was conducted July 25 to August 7, with 614 adults interviewed, and has a margin of error of +/- 4 percent. The New York State survey was conducted August 7-16, with 1,008 adults interviewed. The margin of error is +/- 3 percent. Interviews were conducted in English or Spanish as necessary.



The National Center for Disaster Preparedness at the Mailman School of Public Health is an academically-based, inter-disciplinary program focused on the nation's capacity to prevent and respond to terrorism and major disasters. The NCDP provides curriculum development in bioterrorism, training for public health professionals and other first responders, development of model programs, a wide-ranging research agenda and public policy analysis around issues germane to disaster preparedness. ncdp.mailman/



The only accredited school of public health in New York City, and among the first in the nation, Columbia University's Mailman School of Public Health provides instruction and research opportunities to more than 900 graduate students in pursuit of masters and doctoral degrees. Its students and more than 270 multi-disciplinary faculty engage in research and service in the city, nation, and around the world, concentrating on biostatistics, environmental health sciences, epidemiology, health policy and management, population and family health, and sociomedical sciences. mailman.hs.columbia/



The Children's Health Fund, founded in 1987, is committed to providing health care to the nation's most medically underserved children through the development and support of innovative pediatric programs and the promotion of guaranteed access to appropriate health care for all children. To date, The Children's Health Fund's national network of 21 pediatric programs has treated more than 350,000 children. For more information visit childrenshealthfund/.



Contact: Stephanie Berger


Columbia University's Mailman School of Public Health

Solving An Avian Scourge Could Also Provide Benefits To Human Health

The old adage 'a bird in hand is worth two in the bush' may very well apply to a new vaccine project underway in the lab of ASU School of Life Sciences Professor Roy Curtiss, director of the Center for Infectious Diseases and Vaccinology at the Biodesign Institute.



There, associate research scientist Melha Mellata is leading a USDA funded project to identify targets to develop a vaccine against a leading poultry disease, called avian pathogenic E. coli (APEC).



Mellata is an expert on understanding the genetic signposts of how certain kinds of E. coli turn deadly. "We have to understand how bacteria cause disease so that we can know the best way to fight them," said Mellata.



According to the USDA, the two most common types of poultry infections are from the bacteria E. coli and Salmonella. Unlike in people, Salmonella is completely harmless to chickens.



But by attempting to solve the poultry scourge of APEC, Mellata and Curtiss are hopeful their 'bird in hand' project could ultimately provide a boost to protecting people against Salmonella, the leading cause of food-borne illness.



"What if you could get one vaccine to fight against a group of bacteria?" said Mellata. "We came up with a project where we would protect chickens, not only from E. coli infection but also Salmonella, and in doing so, improve human health."



The U.S. has the leading poultry industry in the world, with an annual value of more than $50 billion and a poultry production forecast to continue its upward trend. E. coli infections are a big threat for the industry. The economic losses due to E. coli infections in broiler chickens were estimated to be more than $80 million in 2002.



Now, there is also considerable concern in the scientific community that APEC strains could become an emergent food pathogen. The poultry products are also a suspected source of a suite of infections called ExPEC (extra-intestinal pathogenic E. coli, which includes APEC), which have been associated with illnesses such as urethral infections, sepsis and meningitis.



Another human health ramification comes from work done by several research groups that have demonstrated that the poultry disease is also similar to other harmful E. coli, including the dreaded E. coli (O157:H7), which is responsible for human illness and death, typically from eating contaminated meat.



Antibiotics have long been the first line of defense to prevent APEC, but have lost their potency, as the bacteria have grown increasingly resistant to treatment.



"It's becoming increasingly important to develop a vaccine to prevent bacterial infection in poultry," said Mellata. "Poultry is not only a daily food staple, but less commonly known, also a key to human health. For example, the entire supply of flu vaccine production is made from eggs."
















Bacterial contamination resulted in half the U.S. flu vaccine supply being destroyed in 2004.



The difficulty in making a vaccine against Salmonella and E. coli is related to their genetic diversity. If the Curtiss research team is to be successful, the vaccine must be effective against a broad spectrum of E. coli and Salmonella groups.



In the past decade several researchers and commercial enterprises have developed Salmonella vaccines for animal health, but they are only effective against a few strains.



The Curtiss group has been a world leader in Salmonella-based vaccines. Curtiss' international team alone has already developed two vaccines that are effective against Salmonella in livestock. By freeing animals from Salmonella, the vaccine is designed to prevent it from traveling down the food chain to people. His vaccine has received FDA approval for use with swine and poultry and is on the market.



The first step in vaccine development is to understand the molecular tricks bacteria use to elude a host's immune system. Within the haystack of the E. coli bacterial genome, the research team has been focused on identifying the genes responsible for triggering its harmful effects.



But in order for the APEC vaccine to pull double duty, they must also demonstrate effectiveness against Salmonella. A key challenge of the project is to see if there is a common thread that can be found in E. coli and Salmonella-which genetically, are very distant cousins at best.



"The problem right now is understanding the virulence of APEC as well as Salmonella to find a way that will protect against all types of the bacteria," said Mellata.



For the past generation, Curtiss has employed Salmonella as a Trojan horse against a variety of harmful pathogens. By using a similar approach, his team is currently developing a vaccine against bacterial pneumonia in a $15 million project funded primarily by the Bill and Melinda Gates Foundation.



For the USDA project, the APEC genes would be shuttled into the Salmonella bacteria in the hopes of triggering a protective immune response against both Salmonella and E. coli.



Mellata feels her team has many APEC gene targets they will use, and they are hard at work to identify several promising factors. The team hopes to have several candidates to test at the end of the three-year, $400,000 project, which will be completed in 2010.







About the Biodesign Institute at ASU



The Biodesign Institute at Arizona State University pursues research to create personalized medical diagnostics and treatments, outpace infectious disease, clean the environment, develop alternative energy sources, and secure a safer world. Using a team approach that fuses the biosciences with nanoscale engineering and advanced computing, the Biodesign Institute collaborates with academic, industrial and governmental organizations globally to accelerate discoveries to market. The institute also educates future scientists by providing hands-on laboratory research for more than 200 students per semester. For more information, go to: biodesign.asu/



Source: Joe Caspermeyer


Arizona State University

Two Indonesian Teenagers Die Of Bird Flu

Indonesian authorities say two teenagers, a boy and a girl, have died of bird flu infection, bringing the country's death toll to 44. When second test results confirm this, Indonesia will have overtaken Vietnam as the country with the highest number of bird flu deaths in the world. Indonesia has also registered more bird flu deaths this year than any other country.


Vietnam has had 42 deaths. However, no one has died of bird flu in Vietnam since the beginning of this year.


Initial lab tests indicated the boy and the girl had were infected with H5N1. The boy, 16, died on Monday, while the girl died on Tuesday. The girl, from Tangerang, was hospitalized on August 4. The boy was from Bekasi.


Indonesia used to send samples to WHO-affiliated labs for confirmation. Now the criteria in Indonesia for confirmation is that if two Indonesian labs confirm, then that case is confirmed and WHO is told about it.


According to local officials, the boy had had extensive contact with infected chickens before he became ill.


Indonesia has asked for financial assistance to combat the spread of bird flu. The country had to deal with a devastating tsunami a couple of years ago which caused about $4 billion in damages and over 100,000 human deaths.


Some facts about Indonesia


Area

1,919,440 sq km (slightly less than three times the size of Texas)

Consits of thousands of islands


Natural Resources

petroleum, tin, natural gas, nickel, timber, bauxite, copper, fertile soils, coal, gold, silver


Natural Hazards

occasional floods, severe droughts, tsunamis, earthquakes, volcanoes, forest fires


Population

245,452,739 (July 2006 estimate)


Age Structure

0-14 years: 28.8% (male 35,995,919/female 34,749,582)

15-64 years: 65.8% (male 80,796,794/female 80,754,238)

65 years and over: 5.4% (male 5,737,473/female 7,418,733) (2006 est.)


Infant Mortality Rate

total: 34.39 deaths/1,000 live births

male: 39.36 deaths/1,000 live births

female: 29.17 deaths/1,000 live births (2006 est.)


Life Expectancy at Birth

total population: 69.87 years

male: 67.42 years

female: 72.45 years (2006 est.)


Ethnic Groups

Javanese 45%, Sundanese 14%, Madurese 7.5%, coastal Malays 7.5%, other 26%


Literacy

total population: 87.9%

male: 92.5%

female: 83.4% (2002 est.)


Religions

Muslim 88%, Protestant 5%, Roman Catholic 3%, Hindu 2%, Buddhist 1%, other 1% (1998)


GDP (Gross Domestic Product)

$270 billion (2005 est.)


Unemployment Rate

11.8% (2005 est.)


Population Below Poverty Line

16.7% (2004)


Written by:





EFPIA Response To The A (H1N1) Novel Influenza Virus

EFPIA is aware and concerned by the current outbreak of a novel influenza, which appears to have originated in Mexico. We note the WHO's decision to raise the level of influenza pandemic alert from the current phase 4 to phase 5. We will continue to monitor the situation closely, working with our colleagues at the International Federation of Pharmaceutical manufacturers and Associations.


Concerns in recent years over the possibility of pandemic avian influenza have meant that both governments and manufacturers have planned for such an eventuality. Therefore we are confident that our members are ready and well prepared to respond rapidly and provide their expertise in dealing with the changing demands of this situation. We are ready to work with governments and public health authorities to provide whatever support may be required.


EFPIA members involved in the manufacture of influenza vaccines and antiviral treatments are already in contact with the relevant authorities. They will provide all necessary, expertise assistance and capacity required to ensure the rapid development of a vaccine effective against the A (H1N1) strain. They will also be meeting with the government bodies at European and Member State levels to determine what assistance they can provide.


The European Vaccine Manufacturers Association, along with antiviral manufacturers, has already met with the European Commission to discuss the situation. The Commission and the industry have examined technical and regulatory issues around speeding production of effective vaccines, and will continue to work together to reduce any impact and spread of the virus.


Brian AGER

European Federation of Pharmaceutical industries and Associations

Animal Study Identifies New DNA Weapon Against Avian Flu

Researchers at the University of Pennsylvania School of Medicine have identified a potential new way to vaccinate against avian flu. By delivering vaccine via DNA constructed to build antigens against flu, along with a minute electric pulse, researchers have immunized experimental animals against various strains of the virus. This approach could allow for the build up of vaccine reserves that could be easily and effectively dispensed in case of an epidemic. This study was published last week in PLoS ONE.


"This is the first study to show that a single DNA vaccine can induce protection against strains of pandemic flu in many animal models, including primates," says David B. Weiner, Ph.D., Professor of Pathology and Laboratory Medicine. "With this type of vaccine, we can generate a single construct of a pandemic flu vaccine that will give much broader protection."


Traditional vaccines expose a formulation of a specific strain of flu to the body so it can create immune responses against that specific strain. Conversely, a DNA vaccine becomes part of the cell, giving it the blueprint it needs to build antigens that can induce responses that target diverse strains of pandemic flu.


Avian flu is tricky. Not only is it deadly, but it mutates quickly, generating different strains that escape an immune response targeted against one single strain. Preparing effective vaccines for pandemic flu in advance with either live or killed viruses, which protect against only one or few cross-strains, is therefore very difficult. How to predict which strain of avian flu may appear at any time is difficult. "We are always behind in creating a vaccine that can effectively protect against that specific strain," notes Weiner.


Instead of injecting a live or killed virus, Penn researchers injected three different species of animal models with synthetic DNA vaccines that are not taken from the flu microbe, but trick the immune system into mounting a broad response against pandemic flu, including strains to which the immune system was never exposed. Antibodies induced by the vaccine rapidly reached protective levels in all three animal species.


"The synthetic DNA vaccines designed in this study customize the antigen to induce more broad immune responses against the pathogen," says Weiner.


Researchers found evidence of two types of immune responses T lymphocytes and antibodies -- in all three types of animal models. Two types of animal models (mice and ferrets) were protected from both disease and mortality when exposed to avian flu.


To ensure increased DNA delivery, the researchers administered the vaccine in combination with electroporation, a small, harmless electric charge that opens up cell pores facilitating increased entry of the DNA vaccine into cells.


If proven in humans, this research could lead the way to preparing against an outbreak of avian flu. Because these synthetic DNA vaccines are effective against multiple cross strains, vaccines could be created, stockpiled, prior to a pandemic, and thus be delivered quickly in the event of an outbreak, surmise the researchers.















This study has shown other advantages of DNA vaccines. On one hand, killed vaccines, which involve the injection of a dead portion of a virus, are relatively safe but usually effective at producing only a strong cellular immunity. Live vaccines, which involve the injection of a form of a live virus, can have increased manufacturing and some safety issues. Both of these vaccine strategies may have concerns in persons with certain allergies (egg for example) as current manufacturing methods rely on egg based production technologies. On the other hand, DNA vaccines preclude the need to create live tissue samples, which presents risk to those working with the virus.


"DNA vaccines have the benefits and avoid many conceptual negatives of other types of traditional vaccines," says Weiner.


This research also has implications for non-avian types of flu. Every year, scientists try to guess what strain of the year will be that creates the common flu. Sometimes their educated guess is wrong, which is why last year's influenza vaccine worked only 30 percent of the time. Designing traditional vaccines in combination with the DNA platform may be a partial solution to this dilemma, predicts Weiner.


In addition to Weiner, Dominick J. Laddy, Jian Yan and Michele Kutzler from Penn; Darwyn Kobasa of the Public Health Agency of Canada; Gary P. Kobinger of the Public Health Agency of Canada and the University of Manatoba; Amir S. Khan, Ruxandra Draghia-Akli and Niranjan Y. Sardesai of VGX Pharmaceuticals; and Jack Greenhouse of Bioqual, Inc. were co-authors. VGX Pharmaceuticals and the National Institute of Allergy and Infectious Diseases provided partial funding for this research.


Dr. Weiner sits on the scientific advisory board of VGX, and collaborates with Wyeth, Merck, BMS, Althea, and Virxsys, as well as other companies on DNA vaccine technologies.


PENN Medicine is a $2.9 billion enterprise dedicated to the related missions of medical education, biomedical research, and high-quality patient care. PENN Medicine consists of theUniversity of Pennsylvania School of Medicine (founded in 1765 as the nation's first medical school) and the University of Pennsylvania Health System.


Penn's School of Medicine is ranked #2 in the nation for receipt of NIH research funds; and ranked #3 in the nation in U.S. News & World Report's most recent ranking of top research-oriented medical schools. Supporting 1,400 fulltime faculty and 700 students, the School of Medicine is recognized worldwide for its superior education and training of the next generation of physician-scientists and leaders of academic medicine.


The University of Pennsylvania Health System includes three hospitals, all of which have received numerous national patient-care honors [Hospital of the University of Pennsylvania;Pennsylvania Hospital, the nation's first hospital; and Penn Presbyterian Medical Center]; a faculty practice; a primary-care provider network; two multispecialty satellite facilities; and home care and hospice.


University of Pennsylvania School of Medicine

3535 Market St., Mezzanine

Philadelphia, PA 19104

United States

med.upenn

Statement On Avian Influenza From Randall L. Tobias, Director Of U.S. Foreign Assistance And USAID Administrator

In the past year, the highly pathogenic H5N1 avian influenza virus moved rapidly outside of Southeast Asia and spread into Europe, Eurasia, and Africa. The disease has been
detected in 53 countries and threatens to derail the significant progress
we have made in international development.



Globally, the disease has borne a tremendous toll. It has already cost
governments and private industries billions of dollars, and caused the
death or destruction of at least 220 million birds, hurting agribusiness,
trade, and opportunities for economic growth. To date, it has also infected
247 humans in 10 countries; almost 60 per cent of these cases have been
fatal.



In addition to loss of life, avian influenza and the risk of a pandemic
pose enormous challenges to global stability. Without aggressive measures
to help build preparedness and response capacity in developing countries,
the disease could proliferate into a pandemic capable of overwhelming even
the most sophisticated healthcare and governmental systems. The
international community must remain committed to fighting avian influenza
by providing assistance to developing countries to prepare for and respond
to a possible pandemic.



The U.S. Government is providing emergency assistance and preparedness
planning to 53 countries through support to international organizations,
including the U.N. Food and Agriculture Organization and the World Health
Organization, foreign governments, private-sector partners, and in-country
organizations. With the funds announced today, USAID's total avian
influenza commitment is $191 million. These funds will strengthen
preparedness, surveillance and response efforts in countries around the
world.



The U.S. is training first responders to learn how to use personal
protective equipment, collect and ship samples, detect disease using
improved laboratory equipment, and provide emergency response to outbreak
situations. To protect frontline field workers so they do not contract or
spread the virus, USAID has deployed approximately 93,000 personal
protective equipment (PPE) kits to 66 countries this year, and is building
a stockpile of 1.5 million protective kits, 100 lab kits, and 15,000
decontamination kits for use by surveillance and outbreak-response workers.



The avian influenza virus is a major global challenge that is
threatening livelihoods as well as economic and social stability,
especially in countries with developing infrastructures. With our continued
international engagement, as with the International Partnership on Avian
and Pandemic Influenza, we can be best prepared to address the challenges
presented by avian influenza and the threat of a pandemic. The global
community must remain vigilant and committed to fighting the virus.



U.S. Agency for International Development

usaid/

FDA Researchers Contribute Insights Into Avian Flu Virus

An in-depth analysis of blood from patients recovering from the H5N1 avian influenza virus has provided important insights into how to combat the potentially lethal virus.


The findings by U.S. Food and Drug Administration scientists and collaborators better explain what part of the "bird flu" virus is seen by the immune system once a person becomes infected. As one result of this research, a protein of the bird flu virus called PB1-F2 was identified as a potentially potent target for attack by immune systems to stop the spread of the virus.


"Analysis of blood from patients recovering from the H5N1 avian influenza virus can lead to new tools for testing the potential protective activity of vaccines under development," said Karen Midthun, M.D., acting director of the FDA's Center for Biologics Evaluation and Research (CBER). "The findings could also lead to new tests to detect infections, and improved therapies."


Since 2003, more than 400 people worldwide have been infected with the bird flu virus. About 60 percent of them have died. No cases of avian flu have been reported in the United States. Most of the avian flu infections in humans involve people who have had direct contact with infected poultry. However, there is a potential risk for a global influenza pandemic should the virus acquire the ability to spread directly from person to person.


The study, titled "Antigenic Fingerprinting of an H5N1 Avian Influenza Using Convalescent Sera and Monoclonal Antibodies reveals Potential Vaccine and Diagnostic Targets," appears in the April 20, 2009, edition of the online journal PLoS Medicine.


The researchers adapted an existing technique using genetically modified viruses (phages) to create a library of fragments representing all of the proteins found in the H5N1 virus. Scientists mixed these fragments with antibodies from five Vietnamese patients recovering from the H5N1 infection and observed which fragments attracted the patient's antibodies.



Several targets that are likely to trigger strong antibody responses to the H5N1 virus were identified, including PB1-F2, a protein that researchers believe contributes significantly to the virus's ability to cause disease.



"We believe this is the first evidence of the human immune system reacting this strongly against PB1-F2," said Hana Golding, Ph.D., chief of CBER's Laboratory of Retrovirus Research and senior author of the article. "This is an indication that it may be a good target for a drug or vaccine."


The study's other authors include first author Surender Khurana, Yonaira Rivera, Jody Manischewitz, and Lisa R. King (FDA); Kanta Subbarao, Amorsolo L. Suguitan Jr. (National Institute of Allergies and Infectious Diseases); Cameron P. Simmons (Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam); and Antonio Lanzavecchia (Institute for Research in Biomedicine, Bellinzona, Switzerland).

Source
U.S. Food and Drug Administration

Bird Flu Suspected In Denmark, Nine Dead Swans Found In Islands

In Denmark, authorities say nine dead Swans have been found on Falter Island and Bornholm island. Falter Island is just 30 miles from the German island of Ruegen where bird flu infected swans were found. Both islands are in the Baltic sea.


The Danish Institute for Food and Veterinary Research are carrying out tests.


Danish poultry farmers have been told to keep all their poultry indoors by the Veterinary and Food Administration.


As bird flu spreads across Western Europe, poultry farmers are experiencing two serious problems. 1. The threat of losing their poultry to infection. 2. Crashing poultry sales. In Italy, supermarkets have reported a 90% drop in the sale of chicken.


Ornithologists say that the spread of bird flu could be accelerated when birds start migrating from Africa, where bird flu is establishing itself (Nigeria), to Europe.


Written by:





GenoMed Offers Trial for Influenza and Avian Influenza

GenoMed (OTC Pink Sheets GMED), a Next Generation Disease Management company whose business is public health, announced today that it has begun Internet-based clinical trials for influenza and avian influenza, since the same treatment approach is expected to work for both kinds of virus.


There is currently no reliable vaccine or treatment for avian influenza. There are antiviral drugs and a vaccine for regular influenza, but they're far from perfect. The yearly influenza vaccine was recently reported to work in only a third of patients.


GenoMed's treatment has been 80% effective in a limited number of patients with West Nile virus encephalitis since 2003. The company is now ready to test it in viral pneumonias.


Any one interested in signing up for GenoMed's clinical trial just needs to go to GenoMed's website (genomed), and then click on "Company News" followed by "Investor Relations/Press Releases" followed by "Presentations" (in the upper right-hand corner). The trial documents are self-explanatory.


About GenoMed


GenoMed's broad-spectrum anti-viral approach was specifically mentioned in BioShield II, recently introduced in the US Senate (see Section 2151 of Senate bill S. 975).


Safe Harbor Statement


This press release contains forward looking statements, including those statements pertaining to GenoMed, Inc.'s (the Company's) finances and treatments. The words or phrases "ought to," "should," "could," "may," or similar expressions are intended to identify "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results could differ materially from those projected in the forward looking statements as a result of a number of risks and uncertainties, including but not limited to our research and development being subject to scientific, economic, regulatory, governmental, and technological factors. Statements made herein are as of the date of this press release and should not be relied upon as of any subsequent date. Unless otherwise required by applicable law, we specifically disclaim any obligation to update any forward-looking statements to reflect occurrences, developments, unanticipated events or circumstances after the date of such statement.


David W. Moskowitz MD

CEO, GenoMed

tel. 314.983.9933

dwmoskowitzgenomed

genomed

Bird Flu - Questions About Animal And Human Health, Pets, Eating Chicken And Eggs, Walking On Footpaths - UK

What does the finding of a dead wild swan with H5N1 mean for animal health?


The Scottish Executive have put in place a 3km Protection Zone and 10 km Surveillance Zone around the area where the swan was found, requiring certain biosecurity measures, the housing of birds, and movement restrictions. Poultry keepers within the Wild Bird Risk Area (which stretches from near Stonehaven in Aberdeenshire down to the Forth Road Bridge) are also required to house their birds. All bird keepers, throughout the UK, should continue their efforts to maintain high levels of biosecurity, and develop their plans to bring their birds indoors should it become necessary.


What does this mean for human health?


H5N1 does not pass easily from birds to people. People can become infected but rarely are. Where they have caught H5N1 in other countries it is because of close and prolonged contact with infected poultry or poultry products. There is no evidence that H5N1 has acquired the ability to pass easily from person to person. Further Information.


Is it safe to eat chicken and eggs?


On the basis of current scientific evidence, advice from the Food Standards Agency is that avian flu does not pose a food safety risk for UK consumers.


What do I do with my cat/dog?


As a precautionary approach, Defra recommend that if you live within 3km of the area where avian influenza has been confirmed (the protection zone) pet owners should aim to keep their cats indoors and exercise their dogs on a lead. This is for the protection of your animals and is not for public health purposes. In all other areas you should continue as normal and your pets are not at risk. Further Information.


What do the restricted areas mean in practice - can I walk on footpaths?


Though Ministers have powers to restrict access to premises in protection zones, in the current situation there is no need for people to automatically reduce their visits to the countryside. Even if the disease spreads we expect there to be little need to restrict access to land by closing footpaths or other rights of way, or land to which there is a general right of access. Further Information.


What should I look out for? Who should I report suspicious bird deaths to?


All dead birds found in the Wild Bird Risk Area should be reported to the Defra Helpline (08459 33 55 77) - Monday-Friday 6.00am to 10.00pm and Saturday-Sunday 6.00am to 10.00pm. In the rest of the country, if you find one or more dead swan(s)/wild fowl (ducks and geese); more than 3 dead birds of the same species or more than 5 dead birds of different species, in the same place, you should contact the Defra Helpline. You will be asked for details of your finding and its location.


defra.uk

Biotech Experts Available To Discuss The Critical Role Of Vaccine Adjuvants In Treating Pandemic Bird Flu

The likelihood of an influenza pandemic caused by an avian influenza (Bird Flu) virus is an increasing concern to the World Health Organization (WHO) and others. Recent breakthroughs on promising cell-based vaccines are encouraging, but manufacturing, stockpiling and distributing enough vaccine to treat victims on a massive scale remain a challenge that needs attention.



Therefore, a vital part of any pandemic preparedness strategy must consider vaccine adjuvants - a critical addition to many developmental vaccines. Adjuvants are designed to improve the immune system response so a reduced amount of the vaccine is required to provide protection.



With many adjuvants - such as Homspera™, a promising drug currently under development by Scottsdale, Ariz.-based biotechnology company ImmuneRegen - the same amount of vaccine may be able to treat many more people.



ImmuneRegen's President and CEO Michael Wilhelm and Chief Scientific Officer Hal Siegel, Ph.D., are available for media interviews to discuss the role of vaccine adjuvants in treating pandemic flu.



ImmuneRegen BioSciences, Inc., a wholly owned subsidiary of IR BioSciences Holdings, Inc. (OTCBB: IRBO), is a development-stage biotechnology company focused on the research, development and licensing of Homspera, an adult stem cell active compound validated to work in human bone marrow. Homspera has been shown to regenerate and strengthen the immune system, increase immune responses to vaccines and enhance wound healing. To advance its mission, the Scottsdale, Ariz.-based company has forged numerous study partnerships with industry and academic leaders, including Celgene Cellular Therapeutics, Lovelace Respiratory Research Institute, U.C. Berkeley, HemoGenix and Virion Systems, Inc.

ImmuneRegen BioSciences, Inc.

Current Bird Flu Outbreak In Turkey Started In Mid-November, Not Mid-December

According to the World Health Organisation, the current outbreak of avian flu in Turkey started at least three weeks before it was officially reported. So far there have been 18 confirmed human cases, of which 3 have died (all siblings).


Turkish officials had said the outbreak started in the middle of December. However, according to Huseyin Sungur, a veterinary surgeon who works for the Turkish government, the outbreak was affecting birds at least three weeks before.


Had this delay not happened it might have been easier to contain the initial outbreak near the border with Iran.


The World Health Organisation has also said that the H5N1 bird flu virus strain has mutated slightly. However, not enough to spread from human-to-human.


At the moment the H5N1 strain infects birds easily. Humans can catch it from birds, but not easily. Over 100 million birds have died over the last three years as a result of this virus strain, but only about 80 people. The virus cannot, at the moment, spread from person-to-person (only in extremely rare cases).


For a human to catch bird flu from a bird there has to be a lot of physical contact.


Health experts around the world say the virus will eventually mutate and become transmissible among humans. When this happens we could be facing a serious global flu pandemic.


One way the virus could mutate might be by infecting a human who has the flu (normal human flu). It could then exchange genetic information with the human flu virus and pick up its ability to spread among humans. If this newly mutated virus turned out to be as deadly as the current H5N1 strain, the consequences could be very serious. On the other hand, the mutated virus could end up being much less harmful.


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Cull Of Cats And Dogs Planned In South Korea To Stem Bird Flu Spread

After an outbreak of H5N1 bird flu at a farm in South Korea, authorities say they plan to cull cats, dogs and pigs to stem the spread of the virus. As there is no evidence that humans can catch bird flu from cats and dogs, experts say the measure is a bit over the top.


125,000 poultry have already been slaughtered at and around the farm in Iksan, 150 miles south of Seoul, where the H5N1 outbreak took place. Ministry of Agriculture officials say all poultry within a half-kilometer radius of the farm will be destroyed. About 240,000 chickens will eventually be slaughtered, as well as 5 or 6 million eggs.


Officials did not say how many dogs, cats and pigs will be culled. Outside Korea, the only place other animals, apart from birds, that have been destroyed has been Indonesia, where pigs were killed to stem the spread of bird flu. In 2003/2004 South Korea destroyed 5.3 million birds and an unspecified number of cats and dogs.


Other countries do slaughter cats and dogs, they just don't admit to it, say South Korean officials. Peter Roeder, Food and Agricultural Organization, Rome, Italy, told the Associated Press the measure is highly unusual and not a science-based decision.


Japan and Hong Kong have 'temporarily' suspended poultry imports from South Korea.


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New Bird Flu Outbreak In Western China Contained

China's Agriculture Ministry says that a new H5N1 bird flu outbreak in the Xinjiang Uygur Autonomous Region of western China has been contained. Last Wednesday authorities reported an outbreak in a chicken farm in Hetian County.


The area lies along the route taken by birds that migrate from Africa to Asia and vice versa. Experts have found that the virus is similar to one that hit migratory birds in Tibet and western Qinghai a few months ago. This raises the possibility that this new outbreak came from migratory birds.


Authorities in China say they are taking measures to prevent transmission from migratory birds to farmed poultry.


More than 17,000 birds have been culled and the area has been disinfected. The Agriculture Ministry says no new outbreaks or suspected bird flu cases have been found near the farm.


So far, 24 Chinese provinces have been affected by the H5N1 bird flu strain since the beginning of 2004. There have been 18 human cases, of which 12 have died.


The World Health Organization says that it is vital to contain all outbreaks of bird flu infection among birds if we want to have a good chance of combating H5N1 and its chances of evolving into a virus that easily transmits from human-to-human. The more outbreaks among birds we can contain, the fewer human cases there will be - if there are fewer human cases we make it more difficult for the virus to find an environment where it can mutate.


For the H5N1 bird flu virus strain to become a serious threat to human health it will need to mutate. At the moment it does not infect humans easily, it very rarely jumps from human to human. However, if it infects a human who already has the normal human flu, it could then exchange genetic information with the human flu virus and acquire the ability to transmit from human-to-human easily - a mutation. Then, we could be facing a serious flu pandemic that would spread around the world within a question of weeks.


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Dramatic Increase In Lower Limb Amputations In Diabetics

Many people suffering foot and leg pain falsely attribute their aches to temporary discomfort or simply "growing old," when something far more serious - and often preventable - is frequently taking place.



People that neglect foot and leg pain - particularly the 20.8 million people in the U.S. with diabetes - can be at risk for amputation. This neglect has contributed to a sharp rise in amputations, with the Centers for Disease Control finding the number of diabetes-related lower limb amputations to have increased by 227 percent between 1980 (33,000) and 2003 (75,000).



Diabetics are prone to amputation as the condition often causes blood vessels in the foot and leg to narrow, causing poor circulation. This makes diabetics susceptible to infection, making it difficult for these wounds to heal. In fact, nine out of 10 non-traumatic lower extremity amputations are instigated by an infection, according to a study led by Texas A&M University. The American Diabetes Association says that diabetes is the most frequent cause of non-traumatic lower limb amputations.



The unfortunate result of these trends is that each year, 75,000 people lose their foot, leg or toe due to diabetes, and 85 percent of these losses could have been avoided, according to the International Diabetes Federation.



New Laser Treatment is an Option in the Fight Against Amputation

Physicians now have a new tool in the fight against amputation. The CLiRpath "cool" excimer laser and catheter procedure vaporizes total arterial blockages that cannot be crossed by standard guidewires (small, flexible wires used to position catheters) in leg and foot arteries, restoring straightline blood flow, which promotes healing. Developed by Spectranetics Corp. (NASDAQ: SPNC), the minimally invasive CLiRpath procedure often enables patients to leave the hospital the day after the treatment. CLiRpath has been the subject of rigorous clinical trials, with limb salvage observed in 95 percent of patients surviving to six months(1).



"Among all the complications from diabetes, amputation can be the worst," said Dr. Craig Walker, of the Cardiovascular Institute of the South, in Houma, La., and one of the country's leading clinical investigators and cardiologists. "Amputation affects a person's quality of life drastically, from mobility to self-image. It is also associated with a decreased life expectancy. But, many amputations can be avoided by simply monitoring the symptoms and talking to a physician about your pain."



Common Warning Signs

The frequent culprit of diabetic amputations is peripheral arterial disease (PAD), in which plaque blocks foot or leg arteries, resulting in pain, development of ulcers and onset of limb loss. According to the American College of Cardiology, common symptoms of PAD are:
















* Discomfort, cramping or heaviness in the toes, feet or legs

* Poorly healing or non-healing wounds on the toes, feet or legs

* Walking impairment

* Pain at rest that is localized to the lower leg or foot

* Abdominal pain that is provoked by eating

* Familial history of a first-degree relative with an abdominal aortic aneurysm



One Man's Story

In 1958, Tom Nelson decided to move from Minnesota to Colorado as a result of his love for the outdoors. Now in his mid-70s, Montrose, Colo., resident Nelson noticed exhaustion and increasing pain in his legs beginning to affect his day-to-day activities. No longer able to take his daily three-mile walks, Nelson's doctor detected arterial blockages in both legs. Fearing the worst, Nelson thought he would be bedridden or possibly facing amputation. This condition (frequently diagnosed as the most severe form of PAD, called Critical Limb Ischemia) is common in older people and particularly diabetics, affecting over 1 million people in the U.S. each year.



His doctor sent Nelson to Dr. Walker to undergo the CLiRpath procedure. Unlike bypass surgery or angioplasty and stenting techniques, the CLiRpath laser can vaporize blockages in the arteries in the leg and foot. Dr. Walker performed the procedure on both of Nelson's legs in February 2006. After a brief hospital stay, Nelson was released.



Nelson has had a stellar recovery since undergoing the CLiRpath procedure. At 75, he is now able to resume his vigorous physical activities, including mowing his 5,000-square-foot lawn without pain.



"Mr. Nelson's case shows that anyone, no matter how healthy, can suffer from arterial blockages in the legs," said Dr. Walker. "Loss of mobility is not always a condition of getting old. Many amputations can be prevented."






(1) Limb salvage for patients surviving to six months (40/42) in LACI CTRO Registry. Limb salvage by intent to treat analysis at six months was 85 percent (40/47 patients).



About Spectranetics Corp.

Spectranetics is a medical device company that develops, manufactures and markets single-use medical devices used in minimally invasive surgical procedures within the cardiovascular system in conjunction with its proprietary excimer laser system. Excimer laser technology delivers relatively cool ultraviolet energy to ablate or remove arterial blockages including plaque, calcium and thrombus. We believe our CVX-300(R) excimer laser is the only system approved in the United States, Europe, Japan, and Canada for use in multiple, minimally invasive cardiovascular procedures. These procedures include atherectomy, which is a procedure to remove arterial blockages in the peripheral or coronary vasculature, and the removal of infected, defective or abandoned cardiac lead wires from patients with pacemakers or implantable cardiac defibrillators, or ICDs, which are electronic devices that regulate the heartbeat. For more information, visit spectranetics/.



Contact: Ken Hunter


PRACO

Lethal H5N1 Bird Flu Strain Confirmed In Cyprus

The European Commission has confirmed that the lethal H5N1 bird flu virus strain has been found in the Turkish part of Cyprus. Cyprus is divided into two parts, the Greek and the Turkish parts.


Greece is part of the European Union while Turkey is not, therefore only the Greek part of Cyprus is part of the EU. Turkey is in talks with the EU about accession.


The border between the two parts of Cyprus is known as The Green Line. The EU says no animal products can cross the Green Line - this includes any kind of bird. Obviously, wild birds come and go as they please and there is nothing authorities can do about them.


The northern part of Cyprus is Turkish while the southern part is Greek.


The EU is sending scientists to the Turkish part of Cyprus to study the disease more carefully.


Over the last two years bird flu (avian flu) has made its way from south east Asia, to Siberia, down to Turkey and now to Cyprus - an island in the Mediterranean sea. The EU is bracing itself for the arrival of bird flu.


The most lethal bird flu strain is the H5N1. This virus strain has so far killed 100 million birds worldwide over the last two years. About 180 humans are known to have caught the infection, of which about half have died.


Scientists say it is only a question of time before the virus mutates and learns how to spread quickly among humans. For the moment, humans can catch bird flu, but just from birds (human to human cases are currently extremely rare). Even so, it does not transmit easily from bird to human.


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Cholesterol-lowering Drugs May Be Useful In An Influenza Pandemic

Recent concerns about the possibility of a serious influenza pandemic have spurred many countries to start stockpiling vaccines and antiviral agents. However, an article in the July issue of Clinical Infectious Diseases, now available online, proposes that cholesterol-lowering drugs known as statins could be helpful, and would be more readily available in the event of a global influenza pandemic.



Statins lower "bad" cholesterol levels in the blood by blocking the liver's production of cholesterol. Statins may further protect the heart by regulating the immune system and reducing inflammation. Recent studies suggest that these effects also help patients with serious infectious diseases such as pneumonia and bacterial infection of the blood.



Because influenza is associated with inflammation and an increased risk of cardiovascular diseases, the anti-inflammatory and immunomodulatory effects of statins might also help people with influenza, suggests David Fedson, MD, a retired former director of medical affairs for a major vaccine maker. If an influenza pandemic did occur, statins would have the added benefit of being immediately available, unlike influenza vaccines, which have to be manufactured after the virus strain is identified.



"It is important to recognize that the statins/influenza idea is only that--an idea," Dr. Fedson said. "It needs to be confirmed by rigorous scientific studies." Statins wouldn't replace vaccines, he added, because "unlike vaccines, they probably wouldn't prevent [influenza virus] infection itself." However, if research demonstrates that statins are beneficial, "their value would most likely be in preventing serious complications and death. In order to do this, they would probably have to be continued throughout the duration of the illness."



Besides being readily available, statins would be relatively inexpensive, particularly the generic varieties. "As generics, they are already being produced in several developing countries and should be available and affordable in almost all countries," Dr. Fedson said. "Keep in mind that very large amounts of statins are produced for tens of millions of cardiovascular disease patients to take year round. For influenza, they probably would be taken for only five to 10 days, and this would not have a major impact on ordinary production and sales levels by the manufacturers."



Further research on statins as treatment and prophylaxis for pandemic influenza, including laboratory studies and clinical trials, is crucial, Dr. Fedson said, concluding in his article that statins "could become the only currently available agents to alter the course of what otherwise might become an unprecedented global health crisis."







Founded in 1979, Clinical Infectious Diseases publishes clinical articles twice monthly in a variety of areas of infectious disease, and is one of the most highly regarded journals in this specialty. It is published under the auspices of the Infectious Diseases Society of America (IDSA). Based in Alexandria, Virginia, IDSA is a professional society representing about 8,000 physicians and scientists who specialize in infectious diseases. For more information, visit idsociety/.



Contact: Steve Baragona

Infectious Diseases Society of America

Bird Flu Vaccine Dosing To Be Tested In Clinical Trial By Duke University Medical Center

A clinical trial to test different strengths of a vaccine designed to fight avian influenza will begin this month at Duke University Medical Center.



The Duke study is part of a multicenter trial that will test a modified form of an investigational bird flu vaccine to determine whether the vaccine still triggers a strong immune response at lower doses.



The seven-month trial is sponsored by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health. Also participating in the study are the University of Maryland, the University of Rochester and Baylor College of Medicine.



"We hope that by adding a compound called an adjuvant to the vaccine, we can create a stronger immune response to smaller doses of the vaccine," said Emmanuel Walter, M.D., associate director of the Duke Clinical Research Institute's Primary Care Research Consortium and leader of the Duke study. "If the smaller dose stimulates immunity against the virus, then more people could be immunized with existing supplies if a pandemic occurs," he said.



The study will use an inactivated flu virus vaccine based on a strain taken from a Vietnamese patient in 2004. "There is no live flu virus in the vaccine, and there is no risk of volunteers contracting bird flu or spreading it to others," Walter said.



The vaccine is designed to protect against the H5N1 strain of bird flu that has infected poultry in Asia, Europe and Africa and killed 101 humans. Initial trials in healthy adults showed the vaccine was safe and produced an immune response but required high doses and at least two injections to initiate a strong response, Walter said.



Trial participants will receive varying strengths of the H5N1 vaccine, either with or without an aluminum hydroxide adjuvant. An adjuvant works by increasing the body's immune response to a vaccine, Walter said. Aluminum hydroxide is commonly used in pediatric and adult vaccines, including those for whooping cough, hepatitis A and hepatitis B.



As with current flu vaccines given yearly in the U.S., the H5N1 vaccine causes the body's immune system to make antibodies to fight infection. In previous studies with this vaccine, two doses were necessary to stimulate antibodies. The doses needed to trigger antibodies were also much higher than necessary for other types of flu, Walter said.







The Duke researchers will recruit approximately 150 volunteers between the ages of 18 and 49 years. The volunteers will have a medical screening, have their blood drawn several times and receive two injections. Volunteers will be randomly assigned to two different groups - one receiving the vaccine with adjuvant and one receiving the vaccine alone. Several different doses will be tested to help determine the right dose to stimulate antibodies. Participants will keep a journal to record any side effects and will receive checkups to monitor their health. Compensation will be provided.



Duke will begin screening potential study volunteers this month. People interested in participating in the study should call (919) 620-5354.



Contact: Becky Oskin

becky.oskinduke

Duke University Medical Center