以加速剂量方案接种的HIV-1重组gp160疫苗。美国国立过敏与传染病研究所艾滋病疫苗临床试验网络。
HIV-1 recombinant gp160 vaccine given in accelerated dose schedules. NIAID AIDS Vaccine Clinical Trials Network.
作者信息
Gorse G J, Schwartz D H, Graham B S, Matthews T J, Stablein D M, Frey S E, Belshe R B, Clements M L, Wright P F, Eibl M
机构信息
Department of Internal Medicine, Saint Louis University School of Medicine, MO.
出版信息
Clin Exp Immunol. 1994 Nov;98(2):178-84. doi: 10.1111/j.1365-2249.1994.tb06122.x.
Abstract
The purpose of this randomized, double-blind study was to test the safety and immunogenicity of an HIV-1LAI recombinant gp160 (rgp160) vaccine in healthy, uninfected volunteers using accelerated dosing schedules. Thirty volunteers were randomly assigned to receive 50-micrograms doses of rgp160 in one of two immunization schedules. Group 1 received rgp160 at times 0, 1, 2 and 5 months; and group 2 received rgp160 at times 0, 1, 2, 3 and 4 months. The vaccine was safe and stimulated high levels of HIV-1 envelope-specific binding antibody and T cell memory. There was a trend (P < 0.10) suggesting neutralizing antibodies were better induced by the regimen incorporating a rest period before the final immunization in group 1 volunteers. Both accelerated immunization schedules induced immune responses at levels similar to or better than those achieved by four rgp160 vaccine injections given over 12-18 months in other studies.
摘要
这项随机双盲研究的目的是，在健康未感染的志愿者中，采用加速给药方案来测试一种HIV-1LAI重组gp160（rgp160）疫苗的安全性和免疫原性。30名志愿者被随机分配，按照两种免疫方案之一接受50微克剂量的rgp160。第1组在第0、1、2和5个月时接受rgp160；第2组在第0、1、2、3和4个月时接受rgp160。该疫苗是安全的，并刺激产生了高水平的HIV-1包膜特异性结合抗体和T细胞记忆。有一个趋势（P<0.10）表明，第1组志愿者在最后一次免疫前纳入休息期的方案能更好地诱导中和抗体。两种加速免疫方案诱导的免疫反应水平与其他研究中在12 - 18个月内给予四次rgp160疫苗注射所达到的水平相似或更好。
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