The National Institute of Allergy and Infectious Diseases (NIAID) recently increased its HIV vaccine clinical trial sites to six, renewing all five current contracts and awarding one new one. The new University of Alabama site joins the other university-based NIAID AIDS Vaccine Evaluation Units (AVEUs) located in St. Louis, Seattle, Nashville, Baltimore and Rochester, N.Y. The Alabama researchers are expected to add to the expertise in the group, especially for trials that evaluate novel oral AIDS vaccines.
The first-year funding for these five-year contracts totals $11.1 million.
The AVEUs are the clinical components of NIAID's AIDS Vaccine Evaluation Group (AVEG). The group also includes two Immunology laboratories, a statistical coordinating center and a central specimen repository that support the clinical trials effort.
Of the more than two dozen candidate AIDS vaccines that have or are being tested in humans worldwide, AVEG has initiated 17 trials with 13 of these products. AVEG pioneered the first Phase II trial of two HIV vaccines, the first trial of an HIV peptide vaccine and the first trial of an oral HIV vaccine.
Anthony S. Fauci, M.D., NIAID director, says, "These awards reinforce out commitment to support clinical trials of a variety of different HIV vaccine approaches in search of the most promising ones."
Patricia Fast, M.D., PhD., chief of the Clinical Development Section of the Vaccine Research and Development Branch within NIAID's Division of AIDS, comments, "We are pleased that the quality of work in the AVEUs resulted in renewed contracts for all of them. We are also excited by the addition of the AVEU in Birmingham. Their expertise in mucosal Immunity is well known and critically important for designing an effective AIDS vaccine." Studies indicate that at least 80 percent of all HIV is transmitted by sex or from infected mothers to their babies. These modes of transmission involve mucosal cells, those found in the fragile membranes lining the respiratory, digestive and reproductive tracts.
The AVEUs comprise the only clinical trial network in the world conducting small-scale (Phase I and II) multi-site clinical trials of experimental preventive HIV vaccines. Each trial enrolls between 10 and several hundred volunteers. Since 1988 more than 1,400 non-HIV-infected men and women have participated in AVEU trials.
These Phase I and II studies, which mainly evaluate safety and immune responses to the vaccines, will help the institute identify the most promising candidates to move into larger Phase III efficacy trials, which are expected to be launched within the next few years. Phase III trials will need several thousand volunteers from populations at high risk of HIV infection to gauge how well the candidate vaccine blocks HIV infection and development of diseases.
Currently, education about behavior modification is the only way known to prevent HIV transmission. All AVEU volunteers receive repeated counseling and education about how to minimize their risk of acquiring HIV infection. All AVEU trials also require explicit informed consent documents that are examined thoroughly by a review board at each AVEU site before the study begins. The informed consent describes the study and any possible risks of trial participation and cautions volunteers that the vaccine may not protect against HIV infection or HIV disease. Staff at the trial site review the consent form with each potential volunteer to make sure he or she understands everything in it before agreeing to participate in the trial.
All the AVEU sites are recruiting volunteers for ongoing and future studies. The following list includes the locations, principal investigators and contact numbers for anyone interested in obtaining more information:
St. Louis, MO - Robert Belshe, M.D., St. Louis University; 314-577-8649. Baltimore, MD - Mary Lou Clements, M.D.,M.P.H., Johns Hopkins University; 410-955-7283. Seattle, WA - Lawrence Corey, M.D., University of Washington; 206-326-4179. Rochester, NY - Raphael Dolin, M.D., University of Rochester; 716-275-5871. Birmingham, AL - Mark Mulligan, M.D., University of Alabama at Birmingham; 205-975-8982. Nashville, TN - Peter Wright, M.D., and Barney Graham, M.D.,Ph.D., Vanderbilt University; 615-343-2437.
NIAID, a component of the National Institutes of Health, supports investigators and scientific studies at universities, medical schools, hospitals and research institutions in the United States and abroad aimed at preventing, diagnosing and treating such illnesses as AIDS, tuberculosis and asthma as well as allergies. NIH is an agency of the U.S. Public Health Service, part of the U.S. Department of Health and Human Services.