Durier Christine, Launay Odile, Meiffrédy Vincent, Saïdi Yacine, Salmon Dominique, Lévy Yves, Guillet Jean-Gérard, Pialoux Gilles, Aboulker Jean-Pierre
INSERM SC10, 16 Avenue Paul-Caillant Couturier, 94800 Villejuif, France.
AIDS. 2006 Apr 24;20(7):1039-49. doi: 10.1097/01.aids.0000222077.68243.22.
HIV-1 lipopeptides have been developed by the French National Agency for AIDS Research (ANRS) for use as candidate vaccine against HIV since 1994. Between 1996 and 2005, four different lipopeptide constructs were tested alone or in combination with recombinant canarypox HIV vaccines in 10 trials conducted in France. The aim of this study was to review clinical safety of HIV lipopeptides.
A meta-analysis based on individual subject data examined clinical safety data collected in eight preventive trials and two therapeutic trials enrolling 200 HIV-1-uninfected healthy volunteers and 48 HIV-1-infected patients.
Of 248 trial participants, eight (3.2%) did not complete follow-up: seven among the 200 healthy volunteers, and one among the 48 HIV-1 infected patients. During the 354 person-years of follow-up, 860 lipopeptides injections were administered. Local reactions were common. However, in trials where lipopeptides were tested without adjuvant and appropriate diluents, none of the vaccinees experienced severe local response. Systemic reactions were generally mild and transient. No grade 4 reaction was reported; 18 subjects experienced grade 3 systemic events related to the vaccination, mainly asthenia, fever, headache and arthralgia. Multivariate analysis showed that female sex, number of injections and diluent (more reactions in 5% glucose alone than in combination with Tris-HCl buffer) significantly increased systemic reactions related to the vaccination.
These data demonstrate that reactogenicity and systemic safety of HIV lipopeptides vaccine are acceptable both in healthy volunteers and HIV-infected adults.
自1994年以来，法国国家艾滋病研究机构（ANRS）已研发出HIV-1脂肽用作抗HIV候选疫苗。1996年至2005年间，在法国进行的10项试验中，单独或与重组金丝雀痘HIV疫苗联合测试了4种不同的脂肽构建体。本研究的目的是回顾HIV脂肽的临床安全性。
基于个体受试者数据进行荟萃分析，检查了八项预防性试验和两项治疗性试验中收集的临床安全性数据，这些试验纳入了200名未感染HIV-1的健康志愿者和48名感染HIV-1的患者。
248名试验参与者中，8人（3.2%）未完成随访：200名健康志愿者中有7人，48名感染HIV-1的患者中有1人。在354人年的随访期间，共注射了860次脂肽。局部反应很常见。然而，在未使用佐剂和适当稀释剂测试脂肽的试验中，没有疫苗接种者出现严重局部反应。全身反应一般较轻且为短暂性。未报告4级反应；18名受试者出现与疫苗接种相关的3级全身事件，主要为乏力、发热、头痛和关节痛。多变量分析显示，女性、注射次数和稀释剂（仅5%葡萄糖中的反应比与Tris-HCl缓冲液联合时更多）显著增加了与疫苗接种相关的全身反应。
这些数据表明，HIV脂肽疫苗的反应原性和全身安全性在健康志愿者和HIV感染的成年人中都是可以接受的。
