Centre pour le Développement des Vaccins, Bamako, Mali.
Vaccine. 2012 Apr 27;30 Suppl 1:A79-85. doi: 10.1016/j.vaccine.2012.01.022.
The efficacy of the pentavalent rotavirus vaccine (PRV), RotaTeq(®), was evaluated in a double-blind, placebo-controlled, multicenter Phase III clinical trial conducted (April 2007-March 2009) in 3 low-income countries in Africa: Ghana, Kenya, and Mali. In total, 5468 infants were randomized 1:1 to receive 3 doses of PRV/placebo at approximately 6, 10, and 14 weeks of age; concomitant administration with routine EPI vaccines, including OPV, was allowed. HIV-infected infants were not excluded. The primary endpoint, vaccine efficacy (VE) against severe-rotavirus gastroenteritis (RVGE), as measured by Vesikari scoring system (VSS, score ≥11), from ≥14 days following Dose 3 through a follow-up period of nearly 2 years in the combined 3 African countries, and secondary endpoints by total follow-up period have been previously reported. In this study, we report post hoc subgroup analyses on secondary endpoints of public health importance. VE against RVGE of any severity was 49.2% (95%CI: 29.9, 63.5) through the first year of life and 30.5% (95%CI: 16.7, 42.2) through the complete follow-up period. VE against severe-gastroenteritis of any etiology was 21.5% (95%CI: <0, 38.4) through the first year of life and 10.6% (95%CI: <0, 24.9) through the complete follow-up period. Through the complete follow-up period, VE against severe-RVGE caused by (i) vaccine-contained G and P types (G1-G4, P1A[8]), (ii) non-vaccine G types (G8, G9, G10), and (iii) non-vaccine P types (P1B[4], P2A[6]) was 34.0% (95%CI:11.2, 51.2), 81.8% (95%CI:16.5, 98.0) and 40.7% (95%CI:8.4, 62.1), respectively. There was a trend towards higher VE with higher disease severity, although in some cases the numbers were small. In African countries with high under-5 mortality rates, PRV significantly reduced RVGE through nearly 2 years of follow-up; more modest reductions were observed against gastroenteritis of any etiology. PRV provides protection against severe-RVGE caused by diverse rotavirus genotypes, including those not contained in the vaccine.
五价轮状病毒疫苗（PRV），罗特律（®）的疗效在非洲 3 个低收入国家（加纳、肯尼亚和马里）进行的一项双盲、安慰剂对照、多中心 III 期临床试验中进行了评估。共有 5468 名婴儿随机分为 1:1 组，分别于大约 6、10 和 14 周龄接受 3 剂 PRV/安慰剂；同时允许常规 EPI 疫苗（包括 OPV）联合使用。未排除 HIV 感染婴儿。主要终点是通过 Vesikari 评分系统（VSS，评分≥11）测量的，从第 3 剂后≥14 天到接近 2 年的联合 3 个非洲国家的随访期间，疫苗对严重轮状病毒胃肠炎（RVGE）的效力（VE），以及总随访期间的次要终点已在之前的报告中报道。在这项研究中，我们报告了对二级终点的事后亚组分析，这些终点对公共卫生很重要。在生命的第一年，任何严重程度的 RVGE 的 VE 为 49.2%（95%CI：29.9，63.5），在整个随访期间为 30.5%（95%CI：16.7，42.2）。任何病因严重胃肠炎的 VE 为 21.5%（95%CI：<0，38.4），在生命的第一年为 10.6%（95%CI：<0，24.9），在整个随访期间。在整个随访期间，对由（i）疫苗包含的 G 和 P 型（G1-G4，P1A[8]）、（ii）非疫苗 G 型（G8、G9、G10）和（iii）非疫苗 P 型（P1B[4]、P2A[6]）引起的严重 RVGE 的 VE 分别为 34.0%（95%CI：11.2，51.2）、81.8%（95%CI：16.5，98.0）和 40.7%（95%CI：8.4，62.1）。虽然在某些情况下数量较少，但随着疾病严重程度的增加，VE 呈上升趋势。在 5 岁以下儿童死亡率较高的非洲国家，PRV 通过近 2 年的随访显著降低了 RVGE；对任何病因引起的胃肠炎观察到更适度的减少。PRV 提供针对多种轮状病毒基因型引起的严重 RVGE 的保护，包括疫苗中未包含的基因型。
