In July, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, announced that University of Iowa Health Care would serve as the lead site for one of its H1N1 adult flu vaccine studies.
Human testing for the new vaccine against novel H1N1 flu began August 11 at UI Hospitals and Clinics, which is one of eight medical centers across the country involved in clinical trials.
Patricia Winokur, MD, principal investigator, and the Vaccine and Treatment Evaluation Unit have joined forces with the University of Washington and Group Health Cooperative in Seattle to help NIAID create safe and effective vaccines to guard against the novel H1N1 flu. In the face of national pressure and a limited turnaround time, approximately 160 individuals were enrolled in the UI study within about one week.
In all, nearly 400 healthy individuals, representing two age groups,18 to 64 and 64 and older, are participating at both sites for the duration of the study. Participants were randomly assigned to one of two vaccine groups. Members of the first group received a smaller dosage of the vaccine (15 mcg), while the second group received a larger dosage (30 mcg). Participants receive two vaccine shots, one at the beginning of the trial and the other three weeks later.
University of Iowa Children's Hospital expects to participate soon in a separate H1N1 vaccine study.
Winokur said it is essential to gain a better understanding of how individuals respond to a vaccine. "This type of research changes policy around the country." She said current research should "ask critical questions that we need to answer for the U.S. to be able to provide vaccines in upcoming months."
One such question focuses on understanding the differences between the younger and older age groups involved in the H1N1 study. Winokur said that in general, members of the 65 and older population fail to respond as positively to flu vaccinations as their younger counterparts do, so tests like these need to be done to determine if there is a better way to vaccinate the elder group (e.g., higher dosage, alternative delivery).
Winokur said that dealing with the H1N1 virus is a "very different story" than vaccinating against other influenza strains that appear during the year because researchers have found some pre-existing antibodies in the 65 and older group, suggesting that older populations might have been exposed to a flu virus when they were young and, as a result, have built-up a certain number of antibodies that help fight the H1N1 virus.
Winokur said people in the study under the age of 65 do not have these same antibodies. This variation between age groups could possibly mean that the age 65 and older group might only need one vaccination whereas the younger population might need two.
"This H1N1 vaccination study has been a great trial for getting community participation," Winokur said, "They want to participate in these trials to help the country make good decisions." Volunteers have come to Iowa City from all over the state because they are interested in being a part of this trial.
A local community volunteer, Marisa Grunder, a UI Hospitals and Clinics employee, said she got involved in the H1N1 vaccine study because she sees it as "breaking research that everybody's talking about." Grunder receives a yearly flu shot and considers the H1N1 vaccine an extension of this routine.
She sees the vaccine as both a safety precaution, guarding against contracting the flu when traveling, and as a proactive means of staying healthy.
"Since I'm one of the first people to get it, I can let other people know that there's nothing to be afraid of and that they should consider it if they feel like it's something that is necessary for them to get," Marisa said.
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