Volunteers get first swine flu test shots
At UM, 47 adults roll up their sleeves for science
Linda Wadsworth, a registered nurse, gives study volunteer Richard Messick, 58, of Baltimore an injection of the H1N1 test vaccine at the University of Maryland's School of Medicine's Center for Vaccine Development. (Baltimore Sun photo by Jed Kirschbaum / August 10, 2009)
The biochemist and seasoned vaccine volunteer jumped at the chance to participate in the first human tests of the H1N1 vaccine. Just last month, the 28-year-old had his blood drawn at the university medical center as a participant in its bird flu vaccine trial. While his drinking buddies think he's "a bit wacky" for offering up himself as a test subject, he insists that the benefits outweigh the risks and that everyone ought to be concerned about the resurgence of swine flu this fall.
Stranen was among 47 adult volunteers who began arriving at the medical center at 7 a.m. for the first wave of trials, part of the government's ambitious effort to prepare for what's expected to be a severe flu season and the first step in what could be a campaign to inoculate millions of the most vulnerable Americans in October.
"Without testing the efficacy and safety, we can't say for sure what this will do," he said. "As a biochemist, I know the importance of this, so I'd feel a little hypocritical not being apart of it."
The University of Maryland's Center for Vaccine Development is one of nine academic sites nationwide testing a vaccine to fight the pandemic. Since the outbreak this spring, the virus has claimed some 436 lives nationwide - including five in Maryland - and sickened as many as 1 million, according to estimates by the Centers for Disease Control and Prevention.
Infectious disease experts fear the virus could mutate into a deadlier strain this fall, and researchers are in a mad dash to have a vaccine ready by the time the season hits.
Nationwide, researchers will enroll 2,400 volunteers in trials that will test two vaccines in five population groups and at two different strengths. Investigators will also study the best time to give the vaccine: before, during or after the typical vaccination schedule for the seasonal flu.
With a throng of television news crews capturing their every step, a steady stream of volunteers filed into the medical center's 10th floor Monday for the two-hour testing process, which began with an orientation session and ended with the prick of a needle.
Like Stranen, many volunteers had a background in medicine or science. They were no strangers to clinical trials and some even knew the UM staffers by first name. Those new to the experience said they were a little nervous, but mostly, they were excited to take part in an effort they hoped would be for the greater good.
"It has infected a lot of people; it's killed people," Chris Lewis, 36, of Baltimore, said of the swine flu virus. "I just want to be able to help [researchers] to better understand the vaccine and find a cure for it."
His girlfriend, Tyra Smith, 26, of Baltimore, reluctantly agreed to accompany him. "I'm scared to death of needles," she announced, moments after having her blood drawn. "But my father told me I should do it, that I'm young and able and I need to do what I can to help."
She added that the $600 compensation for participating in the study was a nice incentive, though "it won't pay the rent." Smith said she has been struggling to find a job for several months.
During orientation, investigators walked participants through the purpose of the trial, the risks and filling out consent forms. Next, medical staff conducted a health assessment to make sure volunteers were healthy enough to participate. Finally, volunteers had their blood drawn and were vaccinated. Participants remained at the center for about 20 minutes after the inoculation to be monitored for possible allergic reactions; none occurred Monday, officials said.
UM's portion of the nine-center vaccine trial will test two doses of a vaccine from manufacturer Sanofi Pasteur. Volunteers will receive the doses three weeks apart and at two strengths - either 15 micrograms or 30 micrograms. Along with 67 adults ages 18-64 who are slated to complete the first round of inoculations this week, 67 elderly volunteers ages 65 and older will receive their initial shots Wednesday through next Tuesday.
Researchers will follow up with volunteers eight days after the first shot for blood tests, which will show if people have developed antibodies that indicate they have an immune response to the virus. Then, volunteers will return two weeks later for another injection.
If all goes well with both groups, the vaccine will be tested in 260 children as soon as the end of next week, said Dr. Karen L. Kotloff, professor of pediatrics and medicine at the Center for Vaccine Development, and the principal investigator for the trial here. By then, researchers should have a good understanding of any reactions the vaccine could cause, she said.
"We have taken this under very careful consideration," she said, adding this vaccine is very similar to the seasonal flu shot, which is not tested on people before it is rolled out every fall. "I don't think there's any scientific basis for being concerned that this vaccine would behave any differently from any other flu vaccine from a safety stand point."
The vaccine will be tried in children as young as 6 months old. Children are among the five priority groups the CDC has indentified should get the virus should there be a mass vaccination effort, since children have been more susceptible to this new flu strain. Medical experts think that older people may have been exposed to similar strains of the virus and may have some immune protection against it.
Kotloff said she has been impressed by the overwhelming response from volunteers. While researchers are still seeking people 65 and older to take part, they have so many young adult volunteers they had to use a lottery system to pick the final participants. Children, too, enrolled in large numbers - especially those with doctors for parents.
"To me, that is very comforting," Kotloff said. "These are people who have a very good understanding of influenza and influenza vaccine, they have weighed, in a very personal way, what the risk and benefits are and have decided to volunteer their children. That says a lot."
Erika Riffle, a certified medical assistant from Frederick, volunteered herself and her 3-year-old son, Tyler, without hesitation.
"I trust the doctors, I trust the medicines and I trust the reputation of the university," Riffle said shortly after receiving the vaccine and a seven-day diary in which she will keep a log of any adverse reactions. "I have all the faith in the world that this is going to be safe."
Her son, meanwhile, has one thing on his mind when he gets the vaccine in a few weeks: "He told me I'm taking him for lollipops afterward."