Clinical Trial Examines Potency and Side Effects of Swine Flu Vaccine

By Rachel Saslow
Washington Post Staff Writer
Tuesday, August 25, 2009

Arthur Fergenson, a 61-year-old Baltimore lawyer, has been volunteering to test vaccines since 1954. That's when, as a second-grader, he stood in line in his school gymnasium to receive a vaccine to prevent polio. He remembers that the nurse didn't stick the needle in far enough, the liquid spurted out of the syringe and he had to get the shot twice.

Two weeks ago, Fergenson rolled up his sleeve again, this time at the University of Maryland Medical Center in Baltimore, one of eight sites for a clinical trial of the H1N1, or swine flu, vaccine. When he received his first dose of the new vaccine, four television cameras filmed him. He shared his story about testing the polio vaccine that evening on the news.

Usually the University of Maryland School of Medicine publicizes its clinical trials and enrolls qualified participants who respond. With H1N1, hundreds of volunteers started calling immediately after the school announced that it would be a site for the trial; lead investigator Karen Kotloff then had to "draw names from a hat" for the 160 slots. Participants didn't find out about the $600 stipend they would earn until they attended orientation sessions at the hospital.

"People really felt they could make a contribution to a public effort, and it was a win-win because they had the possibility of being protected from H1N1 at the same time," Kotloff said.

Marshall Giles Sr., 50, a garbage truck driver for the city of Baltimore, saw Fergenson on the news and was inspired to sign up the next day.

"That got my patriotism going," Giles said as he waited in a hospital hallway with his 19-year-old son. Giles is retired from the Army; his son intends to enlist in the National Guard.

"I really do love my country, and it's my civic duty to come down, as a healthy individual, and participate if I was needed," Giles said.

It turned out that he wasn't: Researchers said they would call him if they needed someone in his age group, but he hasn't heard from them. Some other volunteers were turned away for medical reasons, including egg allergies (the vaccine is manufactured using chicken eggs), pregnancy and having already had H1N1. One man couldn't participate because he had recently been vaccinated against typhoid in preparation for international travel.

In an orientation session for volunteers, Kotloff brought up Guillain-Barré syndrome as a very rare complication of the shot; she gave odds of 1 in 100,000. The neurological disorder killed 12 and paralyzed 400 who were vaccinated during the 1976 U.S. swine flu outbreak.

Kotloff emphasized the more likely risks of participating in the trial: a stiff arm and redness and swelling at the injection site, just as with any other shot. She also cleared up "a misconception in the community":

"There is no living virus in this vaccine, and it cannot give you the flu," she said.

Kotloff sent the participants home with rulers to measure any welts or bruising at the injection site, thermometers and diaries to record any symptoms. None of the four participants interviewed have had anything to report other than soreness at the injection site, nor did they say they were concerned about the risks of participating in the study.

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