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艾滋病疫苗的研发与测试。

Development and testing of AIDS vaccines.

作者信息

Koff W C, Hoth D F

机构信息

Vaccine Research and Development Branch, AIDS Program, National Institute of Allergy and Infectious Diseases, Bethesda, MD 20892.

出版信息

Science. 1988 Jul 22;241(4864):426-32. doi: 10.1126/science.3293212.

Abstract

Recent advances in delineating the molecular biology of human immunodeficiency virus type 1 (HIV-1) have led to innovative approaches to development of a vaccine for acquired immunodeficiency syndrome (AIDS). However, the lack of understanding of mechanisms of protective immunity against HIV-1, the magnitude of genetic variation of the virus, and the lack of effective animal models for HIV-1 infection and AIDS have impeded progress. The testing of AIDS vaccines also presents challenges. These include liability concerns over vaccine-related injuries; identification of suitable populations for phase 3 efficacy studies; balancing the ethical obligation to counsel research subjects to avoid high-risk behavior with the necessity to obtain vaccine efficacy data; and the effect of vaccine-induced seroconversion on the recruiting and welfare of trial volunteers. Several candidate AIDS vaccines are nevertheless currently under development, and some are undergoing phase 1 clinical trials. Rapid progress will depend on continued scientific advancement in conjunction with maximum use of resources, open information and reagent exchange, and a spirit of international collaboration.

摘要

在描绘1型人类免疫缺陷病毒(HIV-1)分子生物学方面的最新进展,已带来开发获得性免疫缺陷综合征(AIDS,艾滋病)疫苗的创新方法。然而,对针对HIV-1的保护性免疫机制缺乏了解、该病毒遗传变异的程度,以及缺乏用于HIV-1感染和艾滋病的有效动物模型,已阻碍了进展。艾滋病疫苗的测试也带来挑战。这些挑战包括对疫苗相关损伤的责任担忧;确定适合进行3期疗效研究的人群;在向研究对象提供咨询以避免高危行为的伦理义务与获取疫苗疗效数据的必要性之间取得平衡;以及疫苗诱导的血清转化对试验志愿者招募和福利的影响。尽管如此,目前仍有几种候选艾滋病疫苗正在研发中,有些正在进行1期临床试验。快速进展将取决于持续的科学进步,同时最大限度地利用资源、开放信息和试剂交换,以及国际合作精神。

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