Center for Vaccinology, Ghent University and Hospital, Ghent, Belgium.
Vaccine. 2010 Oct 8;28(43):7016-24. doi: 10.1016/j.vaccine.2010.08.035. Epub 2010 Aug 20.
This randomized double-blind study aimed to determine the safety and immunogenicity of a gp120/NefTat candidate human immunodeficiency virus type 1 (HIV-1) vaccine formulated with one of three different Adjuvant Systems (AS02(A), AS02(V) and AS01(B)) in healthy HIV-seronegative adults. All vaccine formulations induced strong HIV-specific CD4(+) T-cell responses characterized by high lymphoproliferative capacity and IL-2 production that were still detectable 18 months after last immunization, with strongest responses seen in the AS01(B) group. Broad coverage was demonstrated against gp120, and to a lesser extent Nef, derived from the most common circulating clades (B, C and circulating recombinant form [CRF]-01). All vaccine formulations exhibited acceptable safety and reactogenicity profiles. The demonstration of superior CD4(+) T-cell induction by AS01(B) provides important guidance for future HIV vaccine development.
这项随机、双盲研究旨在确定使用三种不同佐剂系统（AS02(A)、AS02(V)和 AS01(B)）配制的 gp120/NefTat 候选人类免疫缺陷病毒 1 (HIV-1) 疫苗在健康 HIV 血清阴性成年人中的安全性和免疫原性。所有疫苗制剂均诱导强烈的 HIV 特异性 CD4(+) T 细胞应答，其特征是具有高淋巴细胞增殖能力和 IL-2 产生，在最后一次免疫接种后 18 个月仍可检测到，在 AS01(B)组中观察到最强的应答。针对来自最常见流行株（B、C 和循环重组形式 [CRF]-01）的 gp120 和在一定程度上针对 Nef ，显示出广泛的覆盖范围。所有疫苗制剂均表现出可接受的安全性和反应原性特征。AS01(B) 诱导 CD4(+) T 细胞的优越性表明，这为未来的 HIV 疫苗开发提供了重要指导。
