National Institute for Communicable Diseases, A Division of National Health Laboratory Services, Sandringham, South Africa.
Vaccine. 2012 Apr 27;30 Suppl 1:A44-51. doi: 10.1016/j.vaccine.2011.08.080.
Human rotavirus vaccine (HRV; i.e., Rotarix) reduced the incidence of severe rotavirus gastroenteritis (RVGE) by 77% (95% Confidence interval: 56-88%) during the first year of life in South Africa. Persistence of HRV-derived protection against RVGE during subsequent rotavirus seasons, although evident in industrialized settings, remains to be established in African settings. This study reports on the efficacy of HRV against severe RVGE over two consecutive rotavirus seasons in South African children.
A prospective, double-blind, placebo controlled multi-centered trial in South Africa and Malawi randomly assigned infants in a 1:1:1 ratio to receive either two (10 and 14 weeks; HRV_2D) or three (6, 10 and 14 weeks; HRV_3D) doses of HRV or placebo. The primary analysis involved pooling of HRV_2D and HRV_3D arms. Episodes of gastroenteritis caused by wild-type rotavirus were identified through active follow-up surveillance and graded by the Vesikari scale.
1339 infants (447 in the HRV_2D group, 447 in the HRV_3D group and 445 in the placebo group) were enrolled in Year 2 of the study, including 1035 (77.3%) who were followed up over two consecutive rotavirus seasons (i.e., Cohort 2 subjects). Rotarix was associated with ongoing protection against severe RVGE, preventing 2.5 episodes per 100 vaccinated children over two consecutive rotavirus seasons; vaccine efficacy: 59% (95% Confidence interval: 1-83%). An exploratory analysis indicated better immunogenicity (among Cohort 1 subjects) and a higher point-efficacy estimate over two seasons in the HRV_3D compared to HRV_2D arms of the study in Cohort 2 subjects.
Rotarix is associated with significant reductions in severe gastroenteritis episodes through 2 years of life among South African children. Further research is needed to determine the optimal dosing schedule of Rotarix in providing long-term protection against rotavirus illness in African children.
在南非，人类轮状病毒疫苗（HRV，即 Rotarix）可将一岁以下儿童严重轮状病毒肠胃炎（RVGE）的发病率降低 77%（95%置信区间：56-88%）。尽管在工业化国家已经证实 HRV 对 RVGE 的持续保护作用，但在非洲国家仍有待证实。本研究报告了在南非儿童中，连续两个轮状病毒季节中 HRV 对严重 RVGE 的疗效。
在南非和马拉维进行的一项前瞻性、双盲、安慰剂对照的多中心试验中，将婴儿以 1:1:1 的比例随机分配接受两种（10 周和 14 周；HRV_2D）或三种（6 周、10 周和 14 周；HRV_3D）剂量的 HRV 或安慰剂。主要分析包括合并 HRV_2D 和 HRV_3D 臂。通过主动随访监测确定由野生型轮状病毒引起的胃肠炎发作，并根据 Vesikari 量表进行分级。
1339 名婴儿（HRV_2D 组 447 名、HRV_3D 组 447 名和安慰剂组 445 名）被纳入研究的第二年，其中 1035 名（77.3%）在连续两个轮状病毒季节进行了随访（即队列 2 受试者）。Rotarix 持续预防严重 RVGE，每 100 名接种儿童中可预防 2.5 个发病例；疫苗效力：59%（95%置信区间：1-83%）。一项探索性分析表明，在队列 2 受试者中，HRV_3D 组的免疫原性（在队列 1 受试者中）更好，且在两个季节的点疗效估计值更高。
在南非儿童中，Rotarix 可显著降低两岁以下儿童严重胃肠炎发作的发生率。需要进一步研究确定 Rotarix 在为非洲儿童提供针对轮状病毒疾病的长期保护方面的最佳剂量方案。
