AEGiS-11IAC: Phase I/II evaluation of candidate AIDS vaccines.

11th International AIDS Conference


Vancouver, British Columbia — July 7-12, 1996

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Phase I/II evaluation of candidate AIDS vaccines.

Int Conf AIDS 1996 Jul 7-12; 11:9 (abstract no. Mo.A.280)
Graham BS; Vanderbilt University School of Medicine, Nashville, TN, USA.

ISSUE: Development of a preventive vaccine for AIDS.

PROJECT: The AIDS Vaccine Evaluation Group (AVEG) sponsored by NIAID consists of 6 University-based clinical testing sites, 2 central laboratories, a central data processing and analysis unit, and administrative support to select vaccine candidates, evaluate safety, and manage reagent and repository needs. Studies are focused on defining the safety and immunogenicity profiles of candidate vaccines to identify vaccination strategies that are sufficiently promising to be evaluated for efficacy.

RESULTS: The AVEG has enrolled greater than 1700 HIV-1 seronegative individuals in phase I and II clinical trials of candidate AIDS vaccines since 1988. This has included the evaluation of 16 different vaccine antigens, 12 adjuvants, and a variety of delivery vehicles, immunization routes and schedules in over 30 studies. The studies began by evaluating HIV-1 surface glycoprotein antigens delivered parenterally as a purified recombinant proteins in alum. They have evolved to include evaluation of live vaccine vectors, novel delivery vehicles and adjuvants, and internal proteins. Induction of mucosal responses is an important component of the program, and immunologic endpoints include cytotoxic T cell activity and other measures of cellular immunity in addition to serologic assays. Rather than single product regimens, the focus is now on complex vaccine vectors in combination with other products used to boost selected components of the immune response. Composite data on immunologic endpoints from different vaccine strategies will be presented, including instances of vaccine failure in which subjects became infected with HIV-1 despite immunization.

LESSONS LEARNED: Progress in vaccine development has come in small increments, and ultimate success will require cooperation among groups with diverse scientific and social perspectives. Continuing evaluation of modern vaccine concepts in humans, and basic investigation to define mechanisms for inducing HIV-1 immunity will be needed.

Keywords: AEGIS, AIDS Vaccines, HIV-1, Clinical Trials, T-Lymphocytes, Cytotoxic, Vaccines, Adjuvants, Immunologic, Vaccination, Human, nursing, ICA11KWDaegis,aidsvaccines,hiv-1,clinicaltrials,t-lymphocytes,cytotoxic,vaccines,adjuvants,immunologic,vaccination,human,nursing,ica11

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MoA280

Copyright © 1996 - International AIDS Society (IAS). Reproduction of this abstract (other than one copy for personal reference) must be cleared through the IAS.