The Center for Vaccine Development at Saint Louis University began its first round clinical trials of H1N1 inoculations on Monday. Volunteers received an injection in each arm, the first two of five shots study participants will receive. They are testing to see if one or two rounds of H1N1 vaccine injections will produce an immune response. In three weeks, volunteers will receive two more injections and three weeks later, their last injection.
“Of all five of them, two of them are the H1N1 vaccine, one of them is the actual flu shot that everyone else will get and then the other two are placebos,” said 25-year-old Nicholas Sarakas of St. Peters, Mo., one of the first to receive the test vaccine. Participants do not know what order they are receiving the shots. Sarakas said he was told the vaccine SLU is using contains inactive virus.
He works for the St. Charles Convention Center. Being around a lot of people and meeting the demographic of one of the populations most vulnerable to H1N1 influenza, Sarakas decided to sign up to test the vaccine.
“Someone who is younger in their 20s, never really had exposure to many different flu strains out there,” Sarakas described. “I figure I’ll end up getting the flu shot anyway later in the year, so the only difference is I’m getting it now vs. later on in the year.”
Volunteers are to look for any signs of complications.
“They are having me check my temperature, having me check if I’m nauseous, having me check my injection site to see if there [are] reactions or anything. And I actually have to keep track in a diary for a week after each shot,” Sarakas said.
Doctors will follow-up with the volunteers over the next eight months to track their progress.
Dr. Sharon Frey, lead investigator of the NIH-funded H1N1 vaccine trials, said SLU received well over a thousand responses to their initial call for volunteers and are no longer looking for adults for the first trial.
“The first trial will be enrolled by the middle of next week and they’ll have data for that in just a few days after that on a subset of individuals,” Frey said. “The children’s study will follow on the heels of this study and that data will also be available quickly also.”
SLU wants to enroll volunteers for the next trial in a week.
“In addition…we are looking for pregnant women who will be in their second and third trimester to participate in similar swine flu trials,” Frey said.
She said the SLU vaccine study would be similar to the demographic and ethnic population of St. Louis.
“I actually haven’t seen the numbers to date but every community—it is hoped, would enroll people that would be representative of their community, part of the racial group breakdown,” Frey said.
“We anticipate enrolling 200 people in the first study and 200 people in the pediatric study.”
Health officials around the nation are scrambling to have a vaccine available for mass distribution in the next few weeks.
“The government has ordered huge amounts—hundreds of millions of doses of vaccine so it’s a matter of how quickly the pharmaceutical manufacturers can get it shipped out,” she said.
The order of people to be immunized has been prioritized by the CDC to include youngest children first, then pregnant women.
The H1N1 vaccine being tested in St. Louis is manufactured by Sanofi Pasteur.
Anyone interested in the next vaccine trials can contact 314-977-6333.