Rennels M B, Glass R I, Dennehy P H, Bernstein D I, Pichichero M E, Zito E T, Mack M E, Davidson B L, Kapikian A Z
Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, USA.
Pediatrics. 1996 Jan;97(1):7-13.
Rotavirus is a leading cause of morbidity and mortality from dehydrating gastroenteritis in infants and young children worldwide. Virtually every child is infected by age 4 years, justifying universal childhood immunization when a safe and effective vaccine is available. We report the results of a multicenter, placebo-controlled field trial in the United States of monovalent serotype 1 and tetravalent (TV) rhesus-human reassortant rotavirus vaccines (RRVs).
In this randomized, double-blind trial, 1278 healthy infants ages 5 to 25 weeks received three oral doses of RRV serotype 1, RRV-TV, or a placebo at approximately 2, 4, and 6 months of age. Vaccines contained 4 x 10(5) plaque-forming units of virus. Gastroenteritis episodes were monitored, and severity was graded throughout one rotavirus season. Two stool specimens per episode were tested for rotavirus.
The incidence of reactions did not differ among treatment groups during the 5-day, postvaccination safety surveillance period for any of the three doses. Both vaccines significantly reduced the incidence of rotavirus gastroenteritis. Vaccination was most protective against serious rotavirus illness; RRV-TV prevented 49% of rotavirus episodes, 80% of very severe episodes, and 100% of dehydrating rotavirus illness. Reduction of rotavirus disease by RRV-TV resulted in significantly fewer total episodes of gastroenteritis of all causes and an 82% reduction in all cases of dehydrating diarrhea.
RRV-TV is highly protective against very severe, dehydrating rotavirus gastroenteritis.
轮状病毒是全球婴幼儿因脱水型肠胃炎导致发病和死亡的主要原因。事实上，每个儿童在4岁前都会感染轮状病毒，因此当有安全有效的疫苗时，进行普遍的儿童免疫接种是合理的。我们报告了在美国进行的一项关于单价1型和四价（TV）恒河猴-人重配轮状病毒疫苗（RRV）的多中心、安慰剂对照现场试验的结果。
在这项随机、双盲试验中，1278名年龄在5至25周的健康婴儿在大约2、4和6月龄时接受了三剂口服RRV 1型、RRV-TV或安慰剂。疫苗含有4×10⁵蚀斑形成单位的病毒。在整个轮状病毒季节监测肠胃炎发作情况，并对严重程度进行分级。每次发作采集两份粪便标本检测轮状病毒。
在接种后5天的安全监测期内，三种剂量中任何一种的治疗组之间反应发生率均无差异。两种疫苗均显著降低了轮状病毒肠胃炎的发生率。接种疫苗对严重轮状病毒疾病的保护作用最强；RRV-TV预防了49%的轮状病毒发作、80%的非常严重发作以及100%的脱水型轮状病毒疾病。RRV-TV减少轮状病毒疾病导致所有原因引起的肠胃炎总发作次数显著减少，脱水型腹泻病例减少82%。
RRV-TV对非常严重的脱水型轮状病毒肠胃炎具有高度保护作用。
