Kenya Medical Research Institute/Centers for Disease Control and Prevention, Research and Public Health Collaboration, Kenya.
Vaccine. 2012 Apr 27;30 Suppl 1:A52-60. doi: 10.1016/j.vaccine.2011.08.043.
Rotavirus gastroenteritis (RVGE) is a leading cause of death in African children. The efficacy of pentavalent rotavirus vaccine (PRV) against severe RVGE evaluated in Ghana, Kenya, and Mali in a randomized, double-blind, placebo-controlled trial, showed a combined regional efficacy of 39.3% (95% confidence interval [CI]: 19.1,54.7) in nearly 2 years of follow-up. This report concentrates on the Kenya findings.
Infants received 3 doses of PRV/placebo at approximately 6-, 10-, and 14-weeks of age. HIV testing was offered to all participants. Data on illness symptoms and signs were collected upon presentation to healthcare facilities, where stools were collected, and analyzed by rotavirus-specific enzyme-linked immunosorbent assay. The primary endpoint was severe RVGE (Vesikari score ≥ 11), occurring ≥ 14 days following the third dose. At monthly home visits, symptoms of illnesses during the past 2 weeks were solicited and limited physical exams were performed; dehydration was defined by WHO's Integrated Management of Childhood Illness.
Vaccine efficacy (VE) against severe RVGE through nearly 2 years of follow-up among 1308 Kenyan children was 63.9% (95% CI: -5.9,89.8). Through the first year of life, VE against severe RVGE was 83.4% (95% CI: 25.5,98.2). From home visits, VE against all-cause gastroenteritis with severe dehydration was 34.4% (95% CI: 5.3,54.6) through the first year and 29.7% (95% CI: 2.5,49.3) through the entire follow-up period. The reduction in incidence of gastroenteritis with severe dehydration in the community during the first year of life (19.0 cases/100 person-years) was almost six times greater than the reduction in severe RVGE presenting to the clinic (3.3/100 person-years). Oral rehydration solution use was lower among PRV recipients (VE 23.1%, 95% CI: 8.8,35.1). An estimated 41% of gastroenteritis with severe dehydration in the first year reported at home was rotavirus-related.
PRV significantly reduced severe RVGE in Kenya. The impact of PRV might be greatest in rural Africa in protecting the many children who develop severe gastroenteritis and cannot access health facilities.
轮状病毒胃肠炎（RVGE）是非洲儿童死亡的主要原因。在加纳、肯尼亚和马里进行的一项随机、双盲、安慰剂对照试验评估了五价轮状病毒疫苗（PRV）对严重 RVGE 的疗效，结果显示，在近 2 年的随访中，该疫苗的综合区域疗效为 39.3%（95%置信区间[CI]：19.1%，54.7%）。本报告重点介绍肯尼亚的发现。
婴儿在大约 6、10 和 14 周龄时接受 3 剂 PRV/安慰剂。向所有参与者提供 HIV 检测。在出现症状并到医疗机构就诊时，收集有关疾病症状和体征的数据，并通过轮状病毒特异性酶联免疫吸附试验进行分析。主要终点是严重 RVGE（Vesikari 评分≥11），发生在第三剂后≥14 天。在每月的家访中，询问过去 2 周的疾病症状，并进行有限的身体检查；根据世卫组织《儿童期疾病综合管理》定义脱水。
在 1308 名肯尼亚儿童中，近 2 年的随访中，疫苗对严重 RVGE 的疗效为 63.9%（95%CI：-5.9%，89.8%）。在生命的第一年，疫苗对严重 RVGE 的疗效为 83.4%（95%CI：25.5%，98.2%）。从家访中，在生命的第一年，疫苗对所有病因的肠胃炎伴严重脱水的疗效为 34.4%（95%CI：5.3%，54.6%），整个随访期间为 29.7%（95%CI：2.5%，49.3%）。在生命的第一年，社区中严重脱水性肠胃炎的发病率下降了近六倍（19.0 例/100 人年），而到诊所就诊的严重 RVGE 发病率下降了（3.3/100 人年）。PRV 组口服补液盐的使用率较低（VE 23.1%，95%CI：8.8%，35.1%）。估计第一年家中报告的 41%严重脱水性肠胃炎与轮状病毒有关。
PRV 显著降低了肯尼亚的严重 RVGE。在保护许多发展中国家因严重肠胃炎而无法获得医疗服务的儿童方面，PRV 的影响可能在非洲农村最大。
