Analysis of intercurrent human immunodeficiency virus type 1 infections in phase I and II trials of candidate AIDS vaccines
Analysis of intercurrent human immunodeficiency virus type 1 infections in phase I and II trials of candidate AIDS vaccines
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DOI：
10.1086/514209
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发表时间：
1998-02-01
影响因子：
6.4
通讯作者：
Fast, PE
中科院分区：
文献类型：
--
作者：
Graham, BS;McElrath, MJ;Fast, PE
在2099名未感染的艾滋病候选疫苗I期和II期试验受试者中，23名被诊断为并发人类免疫缺陷病毒1型（HIV-1）感染，17名感染者为高危性暴露，6名感染者为静脉注射毒品，4名受试者接受安慰剂，13名接受完全免疫接种（大于或等于3次注射），6例部分免疫（小于或等于2次注射），疫苗接种者和对照组之间在HIV-1感染的发生率、病毒载量、CD 4淋巴细胞计数或V3环氨基酸序列方面没有显著差异，总之，在I期和II期试验期间，19名接种疫苗的受试者获得了HIV 1感染，表明使用所述产品进行免疫接种在预防或快速清除感染方面的有效性< 100%，实验室分析表明疫苗诱导的免疫应答不显著影响传播病毒的基因型或表型特征或HIV-1感染的早期临床病程。
Among 2099 uninfected subjects in phase I and II trials of candidate AIDS vaccines, 23 were diagnosed with intercurrent human immunodeficiency virus type 1 (HIV-1) infection, High-risk sexual exposures accounted for 17 infections, and intravenous drug use accounted for 6, Four subjects received placebo, 13 received a complete immunization schedule (greater than or equal to 3 injections), and 6 were partially immunized (less than or equal to 2 injections), There was no significant difference between vaccine recipients and control groups in incidence of HIV-1 infection, virus load, CD4 lymphocyte count, or V3 loop amino acid sequence, In summary, 19 vaccinated subjects acquired HIV 1 infection during phase I and II trials, indicating that immunization with the products described is < 100% effective in preventing or rapidly clearing infection, Laboratory analysis suggested that vaccine-induced immune responses did not significantly affect the genotypic or phenotypic characteristics of transmitted virus or the early clinical course of HIV-1 infection.