Volunteers needed to test swine flu shots

July 22, 2009 11:09:36 AM PDT
The government called Wednesday for several thousand volunteers to start rolling up their sleeves for the first swine flu shots, in a race to test whether a new vaccine really will protect against the virus before its expected rebound in the fall. The first shots should go into volunteers' arms by the second week of August. A network of medical centers around the country is enrolling for the series of studies directed by the National Institutes of Health.

First, doctors will test different doses of the swine flu vaccine in healthy adults, including the elderly -- two shots, given 21 days apart. If there are no immediate safety concerns, such as allergic reactions, the same testing quickly will begin in babies and children, said Dr. Anthony Fauci, head of NIH's National Institute of Allergy and Infectious Diseases.

Will the results come in time to guide the government's debate on whether to roll out a mass vaccination campaign starting in mid-October, one expected to target mostly school-age children and young adults?

"It's going to be very, very close," Fauci told The Associated Press.

By early September, scientists should have the first clue -- how much immune protection that initial dose triggers. How much protection the second dose adds won't be known for yet another month.

As for safety, the new vaccine is expected to be similar to shots already given each year for seasonal flu. "It ought to be extremely safe," said Dr. William Schaffner, a vaccine specialist at Vanderbilt University, where a colleague will help test the vaccine.

Included in the government studies are vaccines made by Sanofi-Pasteur and CSL Ltd. Also Wednesday, CSL began a much smaller study of its vaccine in Australia, where the company is based.

Soon, vaccine from additional manufacturers -- including the only non-shot version, a nasal spray -- will begin separate, company-led studies in several thousand more volunteers.

But the NIH studies are specifically designed to test how the swine flu vaccine might be used by average Americans, with a set of tests to see how it reacts if given before, with or after the regular winter flu vaccine -- which people are supposed to get as usual this fall.

The NIH's main study sites:
--University of Maryland School of Medicine, Baltimore.
--University of Iowa, Iowa City, Iowa.
--St. Louis University, St. Louis, Mo.
--Baylor College of Medicine, Houston.
--Children's Hospital Medical Center, Cincinnati.
--Emory University, Atlanta.
--Group Health Cooperative, Seattle.
--Vanderbilt University, Nashville, Tenn.

Children's Mercy Hospital in Kansas City and Duke University Medical Center partner with two of those hospitals and also will participate in part of the research.

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