Ethical, behavioral, and social aspects of HIV vaccine trials in developing countries.
OBJECTIVE
Several investigators are preparing to conduct efficacy trials of human immunodeficiency virus (HIV) vaccines in the developing world. Failure to adequately address the unique ethical, behavioral, and social issues that surround vaccine testing in that setting will jeopardize the success of these trials and future acquired immunodeficiency syndrome (AIDS) research in the host nation.


METHODS
Twelve investigators from Africa, Asia, North America, and South America reviewed previous experience with HIV trials in developing countries and explored potential solutions to these issues.


CONCLUSIONS
Host country scientists, government officials, and media must be actively involved in all aspects of the trials. Minimum prerequisites for conducting the trial include the following: (1) researching vaccines active against developing world HIV isolates; (2) establishing and maintaining an adequate technological infrastructure; (3) assessing the feasibility of recruitment in countries where the existence of HIV may be denied; (4) designing methods to obtain informed consent from each individual subject, rather than exclusively from family members or community elders; (5) creating locally appropriate instruments to measure risk behavior; (6) identifying a behavioral intervention for placebo and treatment groups; (7) making available laboratory methods to distinguish between natural HIV infection and vaccine-induced seropositivity; and (8) guaranteeing that an effective vaccine is available free of charge to the placebo group and at affordable prices to other host country residents.
Lurie
P
P
Center for AIDS Prevention Studies, University of California, San Francisco 94105.
Bishaw
M
M
Chesney
M A
MA
Cooke
M
M
Fernandes
M E
ME
Hearst
N
N
Katongole-Mbidde
E
E
Koetsawang
S
S
Lindan
C P
CP
Mandel
J
J
D016915:AIDS Vaccines / Q000592:standards; D002986:Clinical Trials as Topic / Q000592:standards; D003906:Developing Countries; D004989:Ethics; D006801:Humans; D007391:International Cooperation; D038622:Internationality; D018579:Patient Selection; D011786:Quality Control; D035842:Research Subjects; D012309:Risk-Taking; D012924:Social Conditions; D036302:Therapeutic Human Experimentation
D016915:AIDS Vaccines