Swine flu vaccine testing begins at EVMS in Norfolk

NORFOLK

Hampton resident Norman Bretschneider stepped up to the needle on Friday and bared his arm to test a swine flu vaccine at Eastern Virginia Medical School.

He was one of 15 people locally and thousands across the country who participated this week in clinical trials of vaccines for the novel H1N1 virus, known as the swine flu.

Trials are being conducted by the National Institutes of Health and drug companies across the globe in a race to have a vaccine ready by mid-October.

The EVMS study Bret-schneider participated in was for pharmaceutical company Sanofi-Aventis, and included 850 people who were 18 years and older at 15 sites across the country.

"I've been through three wars, so I figured I could help with these studies," said Bretschneider, 78.

The medical school started enrolling people on Thursday. Dr. Rex Biedenbender, the EVMS doctor who is heading the study locally, had hoped to enroll 60 people, but by noon Friday, the drug company had closed the study because enough participants had been selected.

The participants will receive two doses, one this week and one 21 days after the first dose. The tests are expected to gauge side effects, effectiveness and also the amount of the vaccine that is needed.

Three quarters of the participants in the clinical trial will receive the vaccine, and one quarter will receive a placebo, which is an inert dose used for comparison. Those who receive the placebo can receive the real vaccine at the close of the study.

Participants had blood drawn for lab work when the first injection was given, and also will have follow-up blood testing 21 and 45 days after the first shot.

Clinical trials are critical in determining whether to give vaccines to millions of Americans.

Unlike seasonal flu, which hits babies and older people disproportionately hard, the H1N1 virus seems to be targeting school-age children and young adults, so health officials expect an upswing in cases when school resumes in the fall.

Biedenbender, a doctor with the EVMS Glennan Center for Geriatrics and Gerontology, said the center has been participating in flu vaccine studies for years, an effort started by Dr. Stefan Gravenstein, a former director of the center.

Biedenbender said the center called those who had volunteered for flu vaccine studies in the past, and also recruited volunteers by word of mouth.

"Some people, because it's a new formulation of vaccine, have been hesitant to participate, but others hoped to get some protection and were anxious to get it," Biedenbender said.

A government panel has recommended that pregnant women, health care workers and children and young adults ages 6 months through 24 years receive priority for swine flu vaccinations this fall.

Elizabeth Simpson, (757) 446-2635, elizabeth.simpson@pilotonline.com