Kenya Medical Research Institute, Centers for Disease Control and Prevention-Kenya, Nairobi, Kenya.
Vaccine. 2012 Apr 27;30 Suppl 1:A24-9. doi: 10.1016/j.vaccine.2011.08.124.
Efficacy of the pentavalent rotavirus vaccine (PRV), RotaTeq(®), against severe rotavirus gastroenteritis (RVGE) was evaluated in two double-blind, placebo-controlled, multicenter Phase III clinical trials conducted in GAVI-eligible countries in Africa (Ghana, Kenya, and Mali) and in Asia (Bangladesh and Vietnam) from March 2007 through March 2009. The findings from each continent have been analyzed and presented separately, according to a single identical protocol. Ad hoc analyses combining data from the five sites were performed to further assess the impact of PRV.
6674 infants (4705 infants from Africa and 1969 infants from Asia), randomized 1:1 to receive 3 doses of PRV/placebo at approximately 6-, 10-, and 14-weeks of age according to each country's EPI schedule, were included in the per protocol efficacy analysis. Breastfeeding and concomitant administration of EPI vaccines, including OPV, were allowed. Episodes of gastroenteritis (GE) in infants who presented to study facilities were captured and scored using the 20-point Vesikari scale. Stool samples were analyzed by rotavirus-specific EIA to detect presence of rotavirus antigen and RT-PCR to determine the G/P genotypes. We assessed efficacy to prevent all-cause GE and RVGE at a variety of cut-off points (score≥11, severe; score≥15, very severe).
Vaccine efficacy (VE) against RVGE, regardless of serotype, through the entire follow-up period for any severity, severe (score≥11), and very severe (score≥15) was 33.9%, 95% CI (22.7, 43.5), 42.5%, 95% CI (27.4, 54.6), and 51.2%, 95% CI (26.3, 68.2), respectively. Through the first year of life, VE against severe RVGE was 58.9%, 95% CI (40.0, 72.3) and against all-cause severe GE was 23.0%, 95% CI (5.4, 37.3). VE against severe RVGE caused by non-vaccine G serotypes, G8 and G9, through the entire follow-up period was 87.5%, 95% CI (6.8, 99.7) and 48.0%, 95% CI (-5.5, 75.6), respectively. All G8 strains were associated with P2A[6] (a P-type not contained in PRV), while the majority of the G9 strains were associated with P1A[8] (a P-type contained in PRV).
Combining data from the 5 sites strengthens the precision of VE estimates and reveals rising VE with increased RVGE severity. Extrapolating data from VE against severe GE and RVGE suggest that 39% of severe GE episodes during the first year of life were due to rotavirus, highlighting substantial, potentially preventable, public health burden of RVGE. PRV provides protection against non-vaccine serotypes (G8P2A[6]).
五价轮状病毒疫苗（PRV）， Rotateq（®），对严重轮状病毒胃肠炎（RVGE）的疗效在两项在符合 Gavi 条件的非洲国家（加纳、肯尼亚和马里）和亚洲（孟加拉国和越南）进行的双盲、安慰剂对照、多中心 III 期临床研究中进行了评估。根据单一的协议，按照各自的协议分别分析和呈现了来自每个大陆的研究结果。进行了特定分析，将来自五个地点的数据合并在一起，以进一步评估 PRV 的影响。
6674 名婴儿（4705 名来自非洲，1969 名来自亚洲），根据每个国家的 EPI 计划，随机 1:1 接受 3 剂 PRV/安慰剂，大约在 6、10 和 14 周龄，包括在方案疗效分析中。母乳喂养和同时接种 EPI 疫苗，包括 OPV，是允许的。出现胃肠炎（GE）症状的婴儿在研究机构就诊时被捕获并使用 20 分 Vesikari 量表进行评分。通过轮状病毒特异性 EIA 检测粪便样本中轮状病毒抗原的存在，并通过 RT-PCR 确定 G/P 基因型。我们评估了各种严重程度（评分≥11，严重；评分≥15，非常严重）的所有原因 GE 和 RVGE 的疫苗有效性（VE）。
整个随访期间，针对任何严重程度（评分≥11）、严重（评分≥11）和非常严重（评分≥15）的 RVGE，针对所有 RVGE 的疫苗有效性（VE）为 33.9%，95%CI（22.7，43.5），42.5%，95%CI（27.4，54.6）和 51.2%，95%CI（26.3，68.2）。在生命的第一年，针对严重 RVGE 的疫苗有效性为 58.9%，95%CI（40.0，72.3），针对所有严重 GE 的疫苗有效性为 23.0%，95%CI（5.4，37.3）。针对整个随访期间非疫苗 G 血清型 G8 和 G9 引起的严重 RVGE 的疫苗有效性分别为 87.5%，95%CI（6.8，99.7）和 48.0%，95%CI（-5.5，75.6）。所有 G8 株均与 P2A[6]（不在 PRV 中的 P 型）相关，而大多数 G9 株与 P1A[8]（在 PRV 中的 P 型）相关。
从 5 个地点合并数据可以提高 VE 估计的准确性，并显示出随着 RVGE 严重程度的增加 VE 增加。从严重 GE 和 RVGE 的 VE 推断，第一年中 39%的严重 GE 发作归因于轮状病毒，突显了 RVGE 对公共卫生造成的严重、潜在可预防的负担。PRV 提供针对非疫苗血清型（G8P2A[6]）的保护。
