CLINICAL TRIALS OF AIDS VACCINES

Important note: Information in this article was accurate in 1991. The state of the art may have changed since the publication date.

CLINICAL TRIALS OF AIDS VACCINES

AIDS Vaccine Research and Clinical Trials. Putney SD and Bolognesi DP, eds. New York, Marcel Dekker, p. 425-38, 1990.. Unique Identifier : AIDSLINE ICDB/91676958
Koff WC; Wescott SL; Hoth DF; Vaccine Res. and Development Branch, Natl. Inst. of Allergy and; Infectious Diseases, Bethesda, MD

Abstract: Concomitant with the efforts in preclinical vaccine development, preliminary clinical trials of experimental AIDS vaccines have been initiated in the absence of demonstrable protective immunity in animal models. Major issues associated with clinical trials of AIDS vaccines are discussed, including design of Phase 1, 2, and 3 AIDS vaccine trials; populations for AIDS vaccine trials; AIDS vaccines currently in clinical trials; social/ethical issues of AIDS vaccine testing; international issues; and future directions. Clinical trials have been undertaken prior to adequate results in experimental animals for a number of reasons including the urgency of the AIDS pandemic, the capacity of obtaining important scientific knowledge on HIV antigenic stimulation of the human immune system, and a lack of standardized challenge criteria for examining protective immunity in animal models. Clinical trials of AIDS vaccines continue to advance the knowledge of the human immune response to HIV antigens. The immunogenicity of HIV antigens appears to be low, particularly when neutralizing antibody titers during infection are used in comparative analyses with other retroviruses. These findings suggest that potentiation of the immune response against HIV antigens might be a necessary component of HIV vaccine strategies to induce levels of humoral and/or cell-mediated immunity necessary to protect against HIV disease. The preliminary trials of experimental AIDS vaccines, when taken together, have demonstrated a lack of adverse reactions to the varied immunogens, and some studies have demonstrated that a group-specific response to HIV immunogens can be obtained by combining different vaccine approaches. The demonstration that immunity to HIV can be achieved in human beings by vaccination is the first step toward demonstration of protective immunity. (53 Refs)

Keywords: Acquired Immunodeficiency Syndrome/IMMUNOLOGY/*PREVENTION & CONTROL Human HIV/*IMMUNOLOGY HIV Antibodies/BIOSYNTHESIS Neutralization Tests Risk Factors Vaccines, Synthetic/*ADMINISTRATION & DOSAGE/IMMUNOLOGY Viral Vaccines/*ADMINISTRATION & DOSAGE/IMMUNOLOGY MONOGRAPH REVIEW
912130
M91C4084

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