HIV Vaccine Preparedness StudyDate: March 1, 1995
Source: National Institutes of Health (NIH)
Author: National Institute of Allergy and Infectious Diseases (NIAID)
The National Institute of Allergy and Infectious Diseases (NIAID) is committed to the development and testing of vaccines that will prevent HIV disease and its transmission. In June 1994, following recommendations from the NIAID AIDS Research Advisory Committee (ARAC), the Institute decided to continue, but not expand, its ongoing Phase II trial of two candidate HIV vaccines. NIAID since has proceeded with its HIV vaccine research program, including several vaccine trials, continuing development of new vaccine candidates and preparation for future vaccine efficacy trials.
NIAID established the HIV Vaccine Efficacy Trials Network (HIVNET) in 1993 to lay the groundwork for launching preventive HIV vaccine trials. The Vaccine Preparedness Study (VPS), conducted within the HIVNET, concentrates on preparations for HIV vaccine trials in the United States, while other HIVNET studies focus on preparing for HIV vaccine trials in several developing countries. The two main goals of the VPS are to establish the feasibility of procedures that might be used in vaccine trials and to establish, with community involvement, a network of study sites, necessary for the rapid and efficient implementation of Phase III trials to evaluate HIV vaccines and other prevention techniques. The VPS is a prospective, multi-center, epidemiologic study of 4,800 HIV seronegative, at-risk participants. VPS has the following objectives:
1. Estimate HIV seroincidence over time under conditions comparable to those of a vaccine trial, with responsible and achievable risk reduction counseling. 2. Estimate willingness to enroll in HIV vaccine trials over time. 3. Identify motivators and barriers to enrollment in HIV vaccine trials. 4. Identify deficits in participants' knowledge related to HIV vaccine trials, and develop and evaluate strategies to increase knowledge. 5. Characterize the natural history of early HIV infection, including genetic, immunologic and biologic characteristics in populations suitable for vaccine trials.
The VPS is conducted at eight institutions under subcontract to ABT Associates, the domestic master contractor for the HIVNET. The eight organizations are: Denver Department of Public Health in Colorado; Fenway Community Health Center in Boston, Mass.; Howard Brown Health Center in Chicago, Ill.; New York Blood Center in New York City; New York University in New York City; San Francisco AIDS Office/Public Health Foundation Enterprises Inc. in California; University of Pennsylvania in Philadelphia; and University of Washington in Seattle. The Fred Hutchinson Cancer Research Center in Seattle, Wash., is the statistical and data coordinating center for the HIV-NET study, and the California Department of Health Services Viral and Rickettsial Disease Laboratory in Berkeley is the central laboratory.
NIAID, a component of the National Institutes of Health, 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: Office of Communications National Institute of Allergy and Infectious Diseases National Institutes of Health Bethesda, MD 20892
Public Health Service U.S. Department of Health and Human Services