Local/Tri-State
Bird flu vaccine to be tested on humans
BALTIMORE (AP) - The University of Maryland School of Medicine and two other institutions will begin human tests next week of a vaccine designed to combat avian influenza.
The vaccine is designed to prevent a flu strain known as H5N1, which jumped from birds to humans after it was first identified in Hong Kong in 1997. There have been at least 69 confirmed cases and 46 deaths, none in the United States.
Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, told microbiologists gathered in Baltimore Wednesday that the government has stockpiled the equivalent of 2 million doses of the untested H5N1 vaccine at a cost of $13 million in case of an outbreak here or overseas, The (Baltimore) Sun reported.
Distributing the vaccine would require clinical trials and federal regulatory approvals.
Fauci and medical school researchers announced the trials at the annual Biodefense Research Meeting sponsored by the American Society for Microbiology in Baltimore.
UM Researchers will begin recruiting volunteers next week to test the vaccine. Clinical trials will also be conducted at the University of California, Los Angeles and the University of Rochester. Researchers at each medical school seek 150 healthy adults. Participants will be given two shots of the vaccine a month apart, with their health monitored in followup visits and phone calls, according to Dr. James Campbell, an assistant professor of pediatrics at the UM medical school and principal investigator here.
Participants will be required to keep journals to record any side effects from the vaccine. Participants will be paid up to $530, and their health will be monitored for seven months, Campbell said.
To develop the vaccine, scientists used an inactive strain of avian flu taken from a Vietnamese patient in February 2004. Campbell said there are no live flu cultures in the vaccine, and there is no risk of volunteers contracting H5N1 from the injections or spreading it to others. "The vaccine has no virus in it, so you can't get the virus from it," he said.
Fauci said a vaccine for H5N1 could help prevent a global pandemic. H5N1 has spread from Hong Kong to at least nine other Asian countries and has been found in cats, pigs, ducks, chickens and humans. In contrast with other flu strains, humans have never developed H5N1 antibodies because they've never been exposed to it.
"The host range of H5N1 is not restricted. It's spreading, and that's a very bad sign in the evolution of microbes," Fauci told the researchers.
Federal officials last year announced the awarding of H5N1 contracts to two manufacturers. Along with Sanofi Pasteur, Chiron Corporation of Emeryville, Calif., is developing a vaccine that will be tested in clinical trials this year, Fauci said.
Human-to-human spread of H5N1 is rare. Most victims are infected by contact with diseased birds, but because flu viruses can mutate, scientists say H5N1 could develop the ability to spread among humans.
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Information from: The Sun, http://www.baltsun.com
