Fwd: H5N1 AVIAN FLU VIRUS VACCINE INDUCES IMMUNE RESPONSES IN HEALTHY ADULT

March 31, 2006

Hi All-

For all concerned about what's happening with a vaccine for the Avian flu,

here's

the latest.

Traditional Oriental Medicine

753 N. Main Street, Suite C-1

Cottonwood, AZ 86326

(928) 274-1373

--- " NIH OLIB (NIH/OD) " <olib wrote:

> Thu, 30 Mar 2006 09:09:20 -0500

> " NIH OLIB (NIH/OD) " <olib

> H5N1 AVIAN FLU VIRUS VACCINE INDUCES IMMUNE RESPONSES IN HEALTHY

ADULT

> NIHPRESS

>

> U.S. Department of Health and Human Services

> NATIONAL INSTITUTES OF HEALTH

> NIH News

> National Institute of Allergy and Infectious Diseases (NIAID)

> http://www3.niaid.nih.gov/

>

> EMBARGOED FOR RELEASE: Wednesday, March 29, 2006; 5:00 p.m. ET

>

> CONTACT: NIAID News Office, 301-402-1663, niaidnews

>

> H5N1 AVIAN FLU VIRUS VACCINE INDUCES IMMUNE RESPONSES IN HEALTHY ADULTS

>

> Results from a clinical trial demonstrate that high doses of an

> experimental H5N1 avian influenza vaccine can induce immune responses in

> healthy adults. Approximately half of those volunteers who received an

> initial and a booster dose of the highest dosage of the vaccine tested

> in the trial developed levels of infection-fighting antibodies that

> current tests predict would neutralize the virus. The National Institute

> of Allergy and Infectious Diseases (NIAID), part of the National

> Institutes of Health, funded the study, published in the current issue

> of 'The New England Journal of Medicine " . Preliminary results from this

> trial were first disclosed late last summer.

>

> " These findings represent an important step forward in the nation's

> efforts to prepare for the possible emergence of a human pandemic of

> H5N1 avian influenza, " notes NIH Director Elias A. Zerhouni, M.D.

>

> " We are working hard to address the many challenges that remain with

> regard to the development of an H5N1 vaccine, " adds NIAID Director

> Anthony S. Fauci, M.D. " For example, potentially protective immune

> responses were seen most frequently at the highest dose of this vaccine.

> We are investigating other options that may allow us to reduce the

> dosage -- for example, adding an immune booster, or adjuvant, to the

> vaccine -- so we can achieve a more practical immunization strategy. " In

> addition, the U.S. Department of Health and Human Services is pursuing

> other approaches to an H5N1 vaccine, including vaccines made in cell

> cultures rather than grown in eggs.

>

> H5N1 avian influenza viruses are of enormous concern to public health

> officials worldwide. The potential for a human avian flu pandemic looms

> large, say experts, as daily reports indicate an increasing spread of

> infection in bird populations in Southeast Asia, Europe, the Middle East

> and Africa. According to the World Health Organization, as of March 24,

> 2006, 186 people had been infected with avian flu viruses, and more than

> half of them had died.

>

> Generally, flu viruses are easily transmitted from person to person, but

> so far, the H5N1 avian influenza viruses have not demonstrated this

> characteristic. In the worst-case scenario, if an avian flu virus became

> easily transmissible from person to person, it could trigger an

> influenza pandemic because humans have no pre-existing immunity to these

> viruses.

>

> The trial, conducted between March and July 2005, was carried out at

> three NIAID-supported Vaccine and Treatment Evaluation Units located at

> the University of Rochester Medical Center in Rochester, NY; the

> University of Maryland School of Medicine Center for Vaccine Development

> in Baltimore; and the Los Angeles Biomedical Research Institute at

> Harbor-University of California Los Angeles Medical Center. John

> Treanor, M.D., of the University of Rochester, led the group.

>

> The study was conducted in two stages. In the first stage, the research

> team enrolled 118 healthy adults ages 18 to 64 years old. Each

> participant was assigned at random to one of five groups. Volunteers in

> each group received an initial dose of vaccine (7.5 micrograms [mcg], 15

> mcg, 45 mcg or 90 mcg) or saline placebo into the upper arm muscle;

> about one month later, they received a booster shot of the same vaccine

> dosage or the placebo. The research team collected blood samples before

> each vaccination and one month after the second vaccination.

>

> Before the study could be expanded, an independent Data and Safety

> Monitoring Board assessed the vaccine's safety by reviewing data

> collected through day 7 after the second vaccination; no safety concerns

> were found. The investigators then began stage two of the study,

> eventually enrolling an additional 333 healthy adult volunteers into the

> trial according to the same protocol design as in stage one.

>

> The " NEJM " article describes an analysis of data on the safety and

> immune responses to the vaccine. In general, the higher the dosage of

> vaccine, the greater the antibody response produced. Of the 99 people

> evaluated in the 90-mcg, high-dose group, 54 percent achieved a

> neutralizing antibody response to the vaccine at serum dilutions of 1:40

> or greater, whereas only 22 percent of the 100 people evaluated who

> received the 15-mcg dose developed a similar response to the vaccine.

>

> Generally, all dosages of the vaccine appeared to be well tolerated:

>

> -- Almost all reported side effects were mild

>

> -- The second dose of vaccine did not cause more local or systemic

> symptoms than the first

>

> -- Systemic complaints of fever, malaise, muscle aches, headaches and

> nausea occurred with the same frequency in all dosage groups as in the

> placebo group

>

> -- Lab tests did not reveal any clinically significant abnormalities

>

> The vaccine, made from an inactivated H5N1 virus isolated in Southeast

> Asia in 2004, was manufactured by sanofi pasteur, Swiftwater, PA, under

> contract to NIAID. Because there are no manufacturers licensed in the

> United States to use adjuvants in inactivated influenza vaccines,

> NIAID's first step was to test an H5N1 influenza vaccine made in a way

> that mimics the process used to make conventional flu vaccines. The

> clinical data collected in this study are now available to support the

> potential use of this vaccine should it be needed for an emerging

> pandemic.

>

> News releases, fact sheets and other NIAID-related materials are

> available on the NIAID Web site at http://www.niaid.nih.gov.

>

> NIAID is a component of the National Institutes of Health. NIAID

> supports basic and applied research to prevent, diagnose and treat

> infectious diseases such as HIV/AIDS and other sexually transmitted

> infections, influenza, tuberculosis, malaria and illness from potential

> agents of bioterrorism. NIAID also supports research on transplantation

> and immune-related illnesses, including autoimmune disorders, asthma and

> allergies.

>

> The National Institutes of Health (NIH) -- " The Nation's Medical

> Research Agency " -- includes 27 Institutes and Centers and is a

> component of the U.S. Department of Health and Human Services. It is the

> primary federal agency for conducting and supporting basic, clinical and

> translational medical research, and it investigates the causes,

> treatments, and cures for both common and rare diseases. For more

> information about NIH and its programs, visit http://www.nih.gov.

>

> -----------

> Reference: J Treanor et al. Evaluation of an inactivated subunit H5N1

> influenza virus vaccine in humans. " The New England Journal of Medicine "

> 354 (13):1343-51 (2006).

> -----------

>

> ##

>

> This NIH News Release is available online at:

> http://www.nih.gov/news/pr/mar2006/niaid-29.htm.

>

> To (or ) from this list, go to

> http://list.nih.gov/cgi-bin/wa?SUBED1=nihpress & A=1.

>

March 31, 2006

On the other hand... (she had warts ;-)

http://www.knowledgeofhealth.com/

---interesting site of Bill Sardi, with much comment on bird flu.

Ann