Testing for H1N1 flu vaccine under way in Utah

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SALT LAKE CITY -- An advisor to the Centers for Disease Control and Prevention says protecting the public against the new swine flu later this year could potentially involve "the largest mass-vaccination program in human history."

Manufacturers are racing to meet the deadline, including testing volunteers here in Utah, to make sure the vaccine works safely.

The H1N1 virus has already hit hard, making ready for a return visit this flu season. In fact, the World Health Organization projects 2 billion people--one-third of the earth's population--could be infected within two years.

H1N1 flu has resulted in 7,983 hospitalizations and 522 deaths in the United States since April 2009. -CDC

That's why testing clinics, like Jean Brown Research in Salt Lake, are moving rapidly to test the new swine flu vaccine on volunteers.

"It's pivotal, it's crucial that we get this information back to the drug companies so they can submit it to the FDA," said Matt Longson, with Jean Brown Research.

Volunteers sign informed-consent documents, go through extensive screening--including physicals and blood draws--then each participant gets a shot. The process involves not just the initial first-day, three-hour session, but a 25-day follow-up as well.

"After they've had the vaccine, we'll do another blood draw to see whether they're getting antibodies in their system," Longson explained.

The clinic will also stay in contact with these initial test participants throughout the flu season.

Novel H1N1 is a new influenza virus first detected in people in the U.S. in April 2009. This virus is spreading from person-to-person worldwide, probably in much the same way that regular seasonal influenza viruses spread. On June 11, the World Health Organization (WHO) signaled that a pandemic of novel H1N1 flu was underway. This virus was originally referred to as "swine flu" because tests showed that many of the genes in this new virus were very similar to flu viruses that normally occur in pigs in North America. But further study has shown that it has two genes from flu viruses that normally circulate in pigs in Europe and Asia and bird (avian) genes and human genes. *-CDC*
Because of research protocol, KSL News could not use names or show dosages of the volunteers; most will get the new vaccine, but some will not. Again, this is an experimental trial, meaning the volunteers do not know whether they're being injected with the real vaccine or just a placebo. Right now, for H1N1, testing clinics are conducting double-blind studies. Does the vaccine work effectively? What about side effects?

One volunteer said, "They want to know if you have a fever, if you have extreme swelling around the site of the injection."

"Any side effects of a normal flu," added another volunteer.

This is potentially the largest mass-vaccination program in human history.

–Howard Markel, University of Michigan professor of medical history

Most of the people we talked to believe they're sort of setting the stage in these trials--a stage that awaits the really big production.

A third volunteer told us, "I think pandemic in a word scares us all, so I think it's important to realize we can be helped. We don't need to panic."

H1N1 has certainly changed the landscape. If there's enough vaccine to go around, some may need three shots for full protection: the new H1N1 shot, a booster NS the regular seasonal flu shot.

Jean Brown Research begins pediatric clinical trials for the new vaccine this Wednesday for kids 6 months to 9 years of age; adult clinical trials continue for those 18 years and older.

If you are interested in participating in the H1N1 clinical study [CLICK HERE].

E-mail: eyeates@ksl.com

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Ed Yeates


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