一种减毒轮状病毒疫苗预防严重轮状病毒胃肠炎的安全性和有效性。

Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis.

作者信息

Ruiz-Palacios Guillermo M, Pérez-Schael Irene, Velázquez F Raúl, Abate Hector, Breuer Thomas, Clemens SueAnn Costa, Cheuvart Brigitte, Espinoza Felix, Gillard Paul, Innis Bruce L, Cervantes Yolanda, Linhares Alexandre C, López Pío, Macías-Parra Mercedes, Ortega-Barría Eduardo, Richardson Vesta, Rivera-Medina Doris Maribel, Rivera Luis, Salinas Belén, Pavía-Ruz Noris, Salmerón Jorge, Rüttimann Ricardo, Tinoco Juan Carlos, Rubio Pilar, Nuñez Ernesto, Guerrero M Lourdes, Yarzábal Juan Pablo, Damaso Silvia, Tornieporth Nadia, Sáez-Llorens Xavier, Vergara Rodrigo F, Vesikari Timo, Bouckenooghe Alain, Clemens Ralf, De Vos Béatrice, O'Ryan Miguel

机构信息

Instituto Nacional de Ciencas Medicas y Nutricion, México Distrito Federal, Mexico.

出版信息

N Engl J Med. 2006 Jan 5;354(1):11-22. doi: 10.1056/NEJMoa052434.

DOI:10.1056/NEJMoa052434

PMID:16394298

Abstract

BACKGROUND

The safety and efficacy of an attenuated G1P[8] human rotavirus (HRV) vaccine were tested in a randomized, double-blind, phase 3 trial.

METHODS

We studied 63,225 healthy infants from 11 Latin American countries and Finland who received two oral doses of either the HRV vaccine (31,673 infants) or placebo (31,552 infants) at approximately two months and four months of age. Severe gastroenteritis episodes were identified by active surveillance. The severity of disease was graded with the use of the 20-point Vesikari scale. Vaccine efficacy was evaluated in a subgroup of 20,169 infants (10,159 vaccinees and 10,010 placebo recipients).

RESULTS

The efficacy of the vaccine against severe rotavirus gastroenteritis and against rotavirus-associated hospitalization was 85 percent (P<0.001 for the comparison with placebo) and reached 100 percent against more severe rotavirus gastroenteritis. Hospitalization for diarrhea of any cause was reduced by 42 percent (95 percent confidence interval, 29 to 53 percent; P<0.001). During the 31-day window after each dose, six vaccine recipients and seven placebo recipients had definite intussusception (difference in risk, -0.32 per 10,000 infants; 95 percent confidence interval, -2.91 to 2.18; P=0.78).

CONCLUSIONS

Two oral doses of the live attenuated G1P[8] HRV vaccine were highly efficacious in protecting infants against severe rotavirus gastroenteritis, significantly reduced the rate of severe gastroenteritis from any cause, and were not associated with an increased risk of intussusception. (ClinicalTrials.gov numbers, NCT00139347 and NCT00263666.)

摘要

背景

在一项随机、双盲、3期试验中对一种减毒G1P[8]人轮状病毒（HRV）疫苗的安全性和有效性进行了测试。

方法

我们研究了来自11个拉丁美洲国家和芬兰的63225名健康婴儿，这些婴儿在大约2个月和4个月大时口服两剂HRV疫苗（31673名婴儿）或安慰剂（31552名婴儿）。通过主动监测确定严重胃肠炎发作情况。使用20分的韦西卡里量表对疾病严重程度进行分级。在20169名婴儿（10159名接种疫苗者和10010名接受安慰剂者）的亚组中评估疫苗效力。

结果

该疫苗预防严重轮状病毒胃肠炎和轮状病毒相关住院的效力为85%（与安慰剂比较，P<0.001），对更严重的轮状病毒胃肠炎效力达100%。任何原因导致的腹泻住院率降低了42%（95%置信区间为29%至53%；P<0.001）。在每剂疫苗接种后的31天窗口期内，6名接种疫苗者和7名接受安慰剂者发生了明确的肠套叠（风险差异为每10000名婴儿-0.32；95%置信区间为-2.91至2.18；P=0.78）。