Centre pour le Développement des Vaccins, Bamako, Mali.
Vaccine. 2012 Apr 27;30 Suppl 1:A71-8. doi: 10.1016/j.vaccine.2011.11.094.
The oral, pentavalent rotavirus vaccine (PRV), RotaTeq was assessed for prevention of severe rotavirus gastroenteritis (RVGE) in young children in two multi-site, randomized, placebo-controlled field trials; one in Asia (Vietnam and Bangladesh) and the other in sub-Saharan Africa (Ghana, Kenya and Mali). The efficacy results for the Mali site of the multi-country trial are presented here. We randomly assigned infants in a 1:1 ratio to receive 3 doses of PRV/placebo at approximately 6, 10, and 14 weeks of age. Gastroenteritis episodes were captured passively at the local health centers and by home visits. The primary study outcome was severe RVGE, as defined by a score of ≥ 11 using the Vesikari Clinical Scoring System occurring ≥ 14 days after the third dose until the end of the study. Other efficacy analyses included efficacy against severe RVGE through the first year and during the second years of life, as well as efficacy after receiving at least one dose of vaccine. In total, 1960 infants were enrolled in the trial at the Mali site and sera were collected on a subset of infants (approximately 150) for immunogenicity testing. In the first year of follow-up, largely due to cultural practices to visit traditional healers as the first point of care, the point estimate of efficacy was unreliable: the per protocol vaccine efficacy against severe RVGE was 1% (95% confidence interval [CI]: -431.7, 81.6); the intention-to-treat vaccine efficacy was 42.9% (95% CI: -125.7, 87.7). During the second year of follow-up, after the surveillance system was modified to adapt to local customs and health care seeking practices, the point estimate of per-protocol vaccine efficacy was 19.2% (95% CI: -23.1,47.3%). 82.5% of Malian infants (95% CI: 70.1,91.3%) who received PRV mounted a seroresponse (≥ 3-fold rise from baseline (prevaccination) to post-dose 3 vaccination) of anti-rotavirus immunoglobulin A antibody, with a post third-dose geometric mean titer (GMT) of 31.3 units/mL. By contrast, only 20.0% of placebo recipients (95% CI: 10.0, 33.7%) developed a seroresponse and the post-third dose GMT was 3.2 units/mL. None of the serious clinical adverse events observed were considered to be vaccine-related.
口服五价轮状病毒疫苗（PRV），Rotateq，已在两项多中心、随机、安慰剂对照的现场试验中评估预防婴幼儿严重轮状病毒胃肠炎（RVGE）的效果；一项在亚洲（越南和孟加拉国），另一项在撒哈拉以南非洲（加纳、肯尼亚和马里）。这里介绍多国家试验马里现场的疗效结果。我们以 1:1 的比例随机分配婴儿接受 3 剂 PRV/安慰剂，大约在 6、10 和 14 周龄时。在当地卫生中心和家访中被动采集胃肠炎发作病例。主要研究结果是使用 Vesikari 临床评分系统定义的≥ 11 分的严重 RVGE，发生在第三剂后≥ 14 天至研究结束。其他疗效分析包括整个第一年和第二年的严重 RVGE 疗效，以及接种至少一剂疫苗后的疗效。共有 1960 名婴儿在马里现场参加了试验，对部分婴儿（约 150 名）采集了血清进行免疫原性检测。在第一年的随访中，由于文化习俗，首先寻求传统治疗师作为第一级治疗，因此疗效的点估计值不可靠：针对严重 RVGE 的方案疫苗疗效为 1%（95%置信区间[CI]：-431.7，81.6）；意向治疗疫苗疗效为 42.9%（95%CI：-125.7，87.7）。在第二年的随访中，在调整监测系统以适应当地习俗和卫生保健寻求习惯后，方案疫苗疗效的点估计值为 19.2%（95%CI：-23.1，47.3%）。接受 PRV 的马里婴儿中有 82.5%（95%CI：70.1，91.3%）产生了针对轮状病毒免疫球蛋白 A 抗体的血清反应（与基线（接种前）相比，第 3 剂后上升≥ 3 倍），第 3 剂后几何平均滴度（GMT）为 31.3 单位/mL。相比之下，只有 20.0%的安慰剂接受者（95%CI：10.0，33.7%）产生了血清反应，第 3 剂后 GMT 为 3.2 单位/mL。观察到的任何严重临床不良事件均被认为与疫苗无关。
