Emory researchers administered a trial H1N1 flu shot to three volunteers on Aug. 10, kicking off the first of several trials that will test the effectiveness of the new vaccine as part of a national clinical run.
As one of the eight Vaccine and Treatment Evaluation Units (VTEU) supported by the National Institutes of Health (NIH) and National Institute of Allergy and Infectious Diseases (NIAID), Emory is first delivering the vaccine to two age groups of approximately 100 volunteers each — healthy adults aged 19 to 64 and seniors 65 or older. At the end of this week, the University will also launch a clinical trial for children six months to 18 years of age.
Professor of Pediatrics Harry Keyserling, one of the five principal investigators of the Emory VTEU, said the target for healthy adults has already been reached, but enrollment for seniors is still ongoing, and likely to wrap up in the next few days.
“So far there have been no surprises in any vaccine reactions,” Keyserling said. “It is very similar to the seasonal flu vaccine.”
Keyserling said the purpose of the trials is to help determine public policy.
The trials, he said, will help deliver answers to a number of questions: do all age groups need two doses of the pandemic flu shot or do some groups only need one? Should the H1N1 vaccine be administered with the seasonal flu shot or separately? If given separately, does it matter which one comes first?
“We know that the pandemic strain has been a particular problem for young children and young adults,” Keyserling said. “We’ve had epidemics in schools and in summer camps, and we’ve had epidemics on college campuses.”
Student Government Association President Alex Kappus said that SGA has been working on initiatives throughout the summer that will help boost preventative efforts.
“We’re working on doing a better job of reporting when someone gets sick in residence halls and making sure they get checked out,” Kappus said. “There are plans in progress for quarantining those who have swine flu.”
Keyserling said if the government decides to approve the vaccine for the general population, the priority groups of recipients recommended by a Centers for Disease Control (CDC) advisory committee are health care workers, first responders, pregnant women, children six months to 18 years of age, adults from 18 to 24 and individuals from 24 to 65 years of age with underlying health conditions.
The vaccine will be made available in October at the earliest, Keyserling said.
In the clinical trials, researchers will give the volunteers, mostly comprised of community members from the Atlanta area as well as some Emory students and personnel, one dose of the seasonal flu vaccine and two of the H1N1 vaccine, Keyserling said.
Sri Edupuganti, another principal investigator, said the volunteers will receive vaccinations two more times after the first, all spaced three weeks apart. A week after each vaccination, the volunteers will return for an evaluation of any reactions or response, she said, and researchers will draw their blood after three weeks to check the immune response.
“We’ve had a really great response from people, eager to be in the trial,” Edupuganti said. “We haven’t even had to do much recruiting so far. After a press release by the NIH, we started getting calls.”
She said the first group of volunteers seemed completely at ease with the trial.
Edupuganti said another trial testing an adjuvant, or a substance added to a vaccine to foster an improved immune response, will follow next month.
Clinical trials at the other seven VTEU centers — Baylor College of Medicine in Houston; Children’s Hospital Medical Center in Cincinnati; Group Health Cooperative in Seattle; Saint Louis University in St. Louis; University of Iowa in Iowa City; University of Maryland School of Medicine in Baltimore and Vanderbilt University in Nashville — are all underway as well.
For more information about the Emory flu clinical trials, call 877-424-HOPE (4673) for the adult and senior studies, or 404-727-4044 for the pediatric studies.
—Contact Tiffany Han