Migasena S, Suntharasamai P, Pitisuttithum P, Kitayaporn D, Wasi C, Huang W, Vanichseni S, Koompong C, Kaewkungwal J, Raktham S, Ippolito T, Hanson C, Gregory T, Heyward W L, Berman P, Francis D
Vaccine Trial Center, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
AIDS Res Hum Retroviruses. 2000 May 1;16(7):655-63. doi: 10.1089/088922200308882.
A randomized, double-blind, placebo-controlled phase I/II study of AIDSVAX (MN) was conducted among injecting drug users in Bangkok, Thailand. Four doses of vaccine (300 microg of MN-rgp120 in alum) or placebo (alum) were given at study entry and at 1, 6, and 12 months. The objectives of the study were to evaluate (1) the feasibility of conducting vaccine trials in this population; (2) the safety of this candidate AIDS vaccine; and (3) the immunogenicity of this vaccine. Thirty-three volunteers (22 vaccine and 11 placebo recipients) were recruited. None were lost to follow-up during the 18-month study. Mild reactogenicity was noted, which was similar in both vaccine and placebo recipients. The vaccine induced anti-HIV-1 antibody in all vaccine recipients. Maximal titers of binding antibodies of MN-rgp120 and the V3 domain of MN-rgp120 were induced after the third (6 month) dose while maximal neutralizing antibodies followed the fourth (12 month) dose. The vaccine-induced antibodies from several volunteers were capable of neutralizing macrophage-tropic, subtype B viruses (301660 and JRCSF) detected in a PBMC-based assay. Binding and neutralizing antibodies declined about 10-fold in the 6 months after the last boost. Two vaccinees became infected during the trial, both with subtype E viruses. A phase III efficacy trial, using a bivalent gp120 vaccine containing antigens from a subtype B virus (MN) and a subtype E virus (A244), was initiated in March 1999 in injecting drug users in Bangkok.
在泰国曼谷的注射吸毒者中开展了一项关于AIDSVAX（MN）的随机、双盲、安慰剂对照的I/II期研究。在研究开始时以及第1、6和12个月给予四剂疫苗（300微克明矾中的MN-rgp120）或安慰剂（明矾）。该研究的目的是评估：（1）在该人群中开展疫苗试验的可行性；（2）这种候选艾滋病疫苗的安全性；（3）这种疫苗的免疫原性。招募了33名志愿者（22名接种疫苗者和11名接种安慰剂者）。在18个月的研究期间，无一例失访。观察到有轻微的反应原性，在疫苗接种者和安慰剂接种者中相似。该疫苗在所有疫苗接种者中诱导产生了抗HIV-1抗体。在第三剂（6个月）后诱导出MN-rgp120结合抗体和MN-rgp120 V3结构域的最大滴度，而最大中和抗体在第四剂（12个月）后出现。来自几名志愿者的疫苗诱导抗体能够中和在基于外周血单核细胞的检测中检测到的巨噬细胞嗜性B亚型病毒（301660和JRCSF）。在最后一次加强免疫后的6个月内，结合抗体和中和抗体下降了约10倍。两名疫苗接种者在试验期间感染，均感染E亚型病毒。1999年3月，在曼谷的注射吸毒者中启动了一项III期疗效试验，使用一种含有B亚型病毒（MN）和E亚型病毒（A244）抗原的二价gp120疫苗。
