Lurie P, Bishaw M, Chesney M A, Cooke M, Fernandes M E, Hearst N, Katongole-Mbidde E, Koetsawang S, Lindan C P, Mandel J
Center for AIDS Prevention Studies, University of California, San Francisco 94105.
JAMA. 1994 Jan 26;271(4):295-301.
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.
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.
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.
一些研究人员正准备在发展中国家开展人类免疫缺陷病毒（HIV）疫苗的疗效试验。如果不能充分解决在该环境下围绕疫苗测试的独特伦理、行为和社会问题，将会危及这些试验以及东道国未来获得性免疫缺陷综合征（AIDS）研究的成功。
来自非洲、亚洲、北美洲和南美洲的12名研究人员回顾了在发展中国家进行HIV试验的以往经验，并探讨了针对这些问题的潜在解决方案。
东道国的科学家、政府官员和媒体必须积极参与试验的各个方面。开展试验的最低前提条件包括以下几点：（1）研究对发展中国家HIV分离株有效的疫苗；（2）建立并维持足够的技术基础设施；（3）评估在可能否认存在HIV的国家进行招募的可行性；（4）设计方法以从每个个体受试者处获得知情同意，而非仅从家庭成员或社区长者处获得；（5）创建适合当地情况的工具来衡量风险行为；（6）为安慰剂组和治疗组确定一种行为干预措施；（7）提供实验室方法以区分自然HIV感染和疫苗诱导的血清阳性；（8）保证为安慰剂组免费提供有效疫苗，并以可承受的价格向其他东道国居民提供。
