On June 17, 1994, the National Institute of Allergy and Infectious Diseases (NIAID) held a joint meeting in Bethesda, Md., of the NIAID AIDS Research Advisory Committee (ARAC) and the NIAID AIDS Subcommittee of the National Advisory Allergy and Infectious Diseases Council. At the meeting, NIAID solicited a recommendation from the group about whether or not to expand at this time the NIAID's U.S.-based clinical trials of the two gp120 subunit HIV candidate vaccines furthest along in development. Ashley T. Haase, M.D., ARAC chairperson and head of the Department of Microbiology at the University of Minnesota Medical School in Minneapolis, chaired the meeting.
After a full day of discussion and deliberation, these advisors recommended that the Institute continue, but not expand, the current vaccine trials of the two gp120 candidates in question and continue the development of other candidates currently under study. The committee members also recommended NIAID proceed with expanded clinical trial evaluation when a vaccine of a different design and/or when other compelling data from current or other studies are available. In recognition of the difference in the dynamics of the epidemic throughout the world, the majority of the advisers also agreed that at the present time this recommendation applies only to studies of these two products in the United States.
The discussion and subsequent recommendation to NIAID Director, Anthony S. Fauci, M.D., is part of NIAID's ongoing decision-making process about when to begin its first efficacy trial of preventive HIV vaccines. Because of the clear, overwhelming consensus of the advisors, Dr. Fauci adopted the recommendation.
The two vaccines are based on genetically engineered forms of the major HIV surface protein, gp120, from closely related but distinct HIV-1 strains representative of most infections in North America and Europe. The Biocine Company (Emeryville, Calif., a joint venture of Chiron and CIBA-Geigy) makes its vaccine from the SF-2 strain. Genentech, Inc., (South San Francisco) bases its vaccine on the MN strain. At this time, these HIV vaccines are the only ones in an NIAID-sponsored Phase II clinical trial. NIAID began the trial in December 1992.
NIAID will evaluate data from new and ongoing HIV vaccine studies before it identifies a suitable candidate vaccine to propose for expanded trials. The Institute estimates that one to three years are needed to get such data. NIAID is committed to the development of a vaccine to prevent HIV infection and disease. This means continuing the Institute's comprehensive basic and applied program of preclinical and clinical work on candidates and concepts currently in earlier stages of development. Additional community preparedness work will also be carried out. The clinical trials conducted through NIAID's vaccine clinical trial networks are part of a broader prevention effort that includes non-vaccine prevention research.
NIAID, a component of the National Institutes of Health (NIH), supports research on AIDS, tuberculosis and other infectious diseases as well as allergies and immunology. NIH is an agency of the U.S. Public Health Service, U.S. Department of Health and Human Services.Prepared by: