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UI to run swine flu-vaccine trials

BY KURT CUNNINGHAM | JULY 23, 2009 7:15 AM

The UI is one of eight sites that will conduct a series of clinical trials on influenza vaccines, including two dealing directly with the H1N1 virus.

In a series of five trials, health-care professionals will study the effects of the vaccines — particularly what happens when patients are given various doses or when the H1N1 vaccines are paired with the seasonal-flu vaccine.

The vaccines are made by two different companies.

Under the auspices of the National Institute of Allergy and Infectious Diseases, a division of National Institutes of Health, testing is set to begin before the start of autumn and the upcoming flu season.

“We are waiting for all the human-subject approval processes,” said Pat Winokur, an associate dean in the Carver College of Medicine and a lead investigator for one of the trials. “Anytime you use a human subject, rigorous reviews have to occur. And we are currently being reviewed.”

The data being collected will be factored into how to implement an immunization program for the H1N1 flu and to see if it is necessary.

Preliminary studies will look at how many doses — one or two — of a specific vaccine are needed to start creating immunity in adults.

The second part of the trials will test what happens when a healthy adult is given the seasonal-flu vaccine along with a dose of the H1N1 vaccine.

If either study shows signs of being safe in adults, testing on children 6 months to 17 years old will commence accordingly.

Winokur said UI officials are unsure of the specific trials they will conduct, but testing will begin as soon as possible.

The UI has been one of the units used for testing vaccines for the past two years. The NIH picks several areas as primary testing sites; when it needs to conduct research, it uses those locations, Winokur said.

“If we have a study we want to conduct, we can submit it to the NIH,” she said. “But this was a trial that the NIH requested.”

A major concern with the H1N1 virus is the possibility of mutation.

“At this point in time, the good news is that this virus is similar to older strains of flu that have circulated for many years,” she said “ But what is being watched is if it is changing and what it might cause.”

The most recent Center of Disease Control statistics of probable and confirmed cases show 165 Iowans contracted H1N1, with the last update coming July 17. In the U.S., there have been 40,476 probable and confirmed cases and 263 flu-related deaths.


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