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在一项双盲、对照、随机临床试验中,用1型人类免疫缺陷病毒gp160重组痘苗病毒对未接触过痘苗的成年人进行疫苗接种。艾滋病疫苗临床试验网络。

Vaccination of vaccinia-naive adults with human immunodeficiency virus type 1 gp160 recombinant vaccinia virus in a blinded, controlled, randomized clinical trial. The AIDS Vaccine Clinical Trials Network.

作者信息

Graham B S, Belshe R B, Clements M L, Dolin R, Corey L, Wright P F, Gorse G J, Midthun K, Keefer M C, Roberts N J

机构信息

Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN 37232.

出版信息

J Infect Dis. 1992 Aug;166(2):244-52. doi: 10.1093/infdis/166.2.244.

Abstract

The safety and immunogenicity of a human immunodeficiency virus type 1 (HIV-1) gp160 recombinant vaccinia virus (HIVAC-1e) vaccine was evaluated in vaccinia-naive, healthy adults at low risk for acquiring HIV-1 infection. Volunteers (n = 36) were randomized to receive HIVAC-1e or control vaccinia virus at two dosages by bifurcated needle puncture at 0 and 2 months; 12 HIVAC-1e and 6 control vaccinia virus recipients received either 10(6) or 10(7) pfu/mL at each inoculation. There was no significant difference in lesion size, level of viral replication, or systemic symptoms after vaccination with HIVAC-1e or control vaccinia virus. Of 22 HIVAC-1e recipients with lesion formation, 16 developed low-titer gp160-specific antibody responses detectable by Western blot. The peak response occurred between days 70 and 120 and was still detectable at day 365 in 9 of 18 vaccinees. gp160-specific lymphoproliferative responses were detected in 5 of 10 vaccinees. Vaccination with HIVAC-1e was safe in vaccinia-naive, healthy adults and could induce both humoral and cell-mediated gp160-specific immune responses.

摘要

在未感染过牛痘、感染人类免疫缺陷病毒1型(HIV-1)风险较低的健康成年人中,评估了一种HIV-1 gp160重组牛痘病毒(HIVAC-1e)疫苗的安全性和免疫原性。36名志愿者被随机分为两组,于0个月和2个月时通过分叉针穿刺以两种剂量接种HIVAC-1e或对照牛痘病毒;12名HIVAC-1e接种者和6名对照牛痘病毒接种者每次接种分别接受10(6)或10(7) pfu/mL的剂量。接种HIVAC-1e或对照牛痘病毒后,在损伤大小、病毒复制水平或全身症状方面没有显著差异。在22名形成损伤的HIVAC-1e接种者中,16人产生了可通过蛋白质印迹法检测到的低滴度gp160特异性抗体反应。峰值反应出现在第70天至120天之间,在第365天时,18名接种者中有9人的反应仍可检测到。10名接种者中有5人检测到gp160特异性淋巴细胞增殖反应。对于未感染过牛痘的健康成年人,接种HIVAC-1e是安全的,并且可以诱导体液和细胞介导的gp160特异性免疫反应。

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