Rerks-Ngarm Supachai, Pitisuttithum Punnee, Excler Jean-Louis, Nitayaphan Sorachai, Kaewkungwal Jaranit, Premsri Nakorn, Kunasol Prayura, Karasavvas Nicos, Schuetz Alexandra, Ngauy Viseth, Sinangil Faruk, Dawson Peter, deCamp Allan C, Phogat Sanjay, Garunathan Sanjay, Tartaglia James, DiazGranados Carlos, Ratto-Kim Silvia, Pegu Poonam, Eller Michael, Karnasuta Chitraporn, Montefiori David C, Sawant Sheetal, Vandergrift Nathan, Wills Saintedym, Tomaras Georgia D, Robb Merlin L, Michael Nelson L, Kim Jerome H, Vasan Sandhya, O'Connell Robert J
Department of Disease Control, Ministry of Public Health, Nonthaburi.
Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, Bankok
J Infect Dis. 2017 Apr 15;215(8):1255-1263. doi: 10.1093/infdis/jix099.
BACKGROUND: The RV144 ALVAC-HIV prime, AIDSVAX B/E boost afforded 60% efficacy against human immunodeficiency virus (HIV) acquisition at 1 year, waning to 31.2% after 3.5 years. We hypothesized that additional vaccinations might augment immune correlates of protection. METHODS: In a randomized placebo-controlled double-blind study of 162 HIV-negative RV144 vaccine recipients, we evaluated 2 additional boosts, given 6-8 years since RV144 vaccination, for safety and immunogenicity, at weeks 0 and 24. Study groups 1-3 received ALVAC-HIV+AIDSVAX B/E, AIDSVAX B/E, and ALVAC-HIV, respectively, or placebo. RESULTS: Vaccines were well tolerated. For groups 1 and 2, plasma immunoglobulin (Ig) G, IgA, and neutralizing antibody responses at week 2 were all significantly higher than 2 weeks after the last RV144 vaccination. IgG titers against glycoprotein (gp) 70V1V2 92TH023 increased 14-fold compared with 2 weeks after the last RV144 vaccination (14069 vs 999; P < .001). Groups 1 and 2 did not differ significantly from each other, whereas group 3 was similar to placebo recipients. Responses in groups 1 and 2 declined by week 24 but were boosted by the second vaccination, albeit at lower magnitude than for week 2. CONCLUSIONS: In RV144 vaccinees, AIDSVAX B/E with or without ALVAC-HIV 6-8 years after initial vaccination generated higher humoral responses than after RV144, but these responses were short-lived, and their magnitude did not increase with subsequent boost. CLINICAL TRIALS REGISTRATION: NCT01435135.
背景：RV144疫苗采用ALVAC-HIV初免、AIDSVAX B/E加强免疫，在1年时对人类免疫缺陷病毒（HIV）感染的预防效果为60%，3.5年后降至31.2%。我们推测额外的疫苗接种可能会增强保护性免疫相关指标。 方法：在一项针对162名HIV阴性的RV144疫苗接种者的随机、安慰剂对照、双盲研究中，我们评估了在RV144疫苗接种6至8年后，于第0周和第24周进行的另外两次加强免疫的安全性和免疫原性。研究组1至3分别接受ALVAC-HIV+AIDSVAX B/E、AIDSVAX B/E、ALVAC-HIV或安慰剂。 结果：疫苗耐受性良好。对于第1组和第2组，第2周时血浆免疫球蛋白（Ig）G、IgA和中和抗体反应均显著高于最后一次RV144疫苗接种后2周。与最后一次RV144疫苗接种后2周相比，针对糖蛋白（gp）70V1V2 92TH023的IgG滴度增加了14倍（14069对999；P < 0.001）。第1组和第2组之间无显著差异，而第3组与安慰剂接种者相似。第1组和第2组的反应在第24周时下降，但第二次接种后有所增强，尽管增强幅度低于第2周。 结论：在RV144疫苗接种者中，初次接种6至8年后接种AIDSVAX B/E（无论是否联合ALVAC-HIV）产生的体液反应高于RV144疫苗接种后，但这些反应持续时间短，且后续加强免疫后反应幅度未增加。 临床试验注册号：NCT01435135。
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