The Stanford University School of Medicine is recruiting participants for a clinical trial to determine the safety of an experimental vaccine against the new H1N1 strain of influenza when the vaccine is combined with an immune-stimulating substance called an adjuvant. The trial will also examine whether use of the adjuvant improves the immune response to the vaccine.
Most people’s immune systems have never been exposed to any influenza strain closely related to the H1N1 strain, which first began to surface last spring, said Cornelia Dekker, MD, professor of pediatrics and medical director of the Stanford-LPCH Vaccine Program. The novel virus thus has spread quickly, giving rise to a pandemic that has governments around the world scrambling to plan mass-vaccination strategies as a public-health measure.
Early-phase trials, whose primary goals are to determine the safety of the vaccine given by itself and to examine the immune response after one and two doses, are already under way at several centers throughout the country.
Unlike other trials to date, the one at Stanford will test a version of the vaccine that contains an adjuvant: a substance that stimulates the immune system so that it attacks the virus more vigorously. It is possible that the addition of the adjuvant might allow the dose of vaccine to be lowered, thus allowing more people to be immunized, Dekker said. Use of an adjuvant may also provide a higher immune response in persons who do not respond as well to the vaccine alone, such as the elderly. Both of these possibilities will be tested in this trial.
Dekker is the principal investigator at the Stanford site, one of six throughout the country where the vaccine is being tested in the phase-2 trial sponsored by the National Institutes of Health.
Prospective participants are encouraged to visit a dedicated Web site, http://vaccines.stanford.edu/clinical_trials.html, to review study information and join the volunteer mail list, or call (650) 498-7284 to learn more about their potential eligibility for the trial. Dekker noted that people considering participation in the trial should be prepared to make eight separate visits to the Stanford campus, to receive two vaccine doses spaced three weeks apart, undergo several blood draws and engage in four phone conversations with study staff over a 13-month time frame. (Enrolled subjects will receive parking vouchers for their visits and compensation for their time.)
“We’re hoping to get as many as 130 volunteers enrolled at the Stanford site within a very short time,” said Dekker. Prospective subjects must all be at least 18 years old and in general good health. The trial design calls for two-thirds of the selected participants to be in the 18-64 age category, with the remainder drawn from the 65+ population.