一种活的四价人-牛重配轮状病毒疫苗在健康婴儿中的安全性、有效性和免疫原性。

Safety, efficacy, and immunogenicity of a live, quadrivalent human-bovine reassortant rotavirus vaccine in healthy infants.

作者信息

Clark H Fred, Bernstein David I, Dennehy Penelope H, Offit Paul, Pichichero Michael, Treanor John, Ward Richard L, Krah David L, Shaw Alan, Dallas Michael J, Laura Digilio, Eiden Joseph J, Ivanoff Nathalie, Kaplan Karen M, Heaton Penny

机构信息

University of Pennsylvania School of Medicine, Philadelphia, and Merck & Co, Inc, West Point, Pennsylvania 19486, USA.

出版信息

J Pediatr. 2004 Feb;144(2):184-90. doi: 10.1016/j.jpeds.2003.10.054.

DOI:10.1016/j.jpeds.2003.10.054

PMID:14760258

Abstract

OBJECTIVES

To investigate safety, efficacy, and immunogenicity of live quadrivalent rotavirus vaccine (QRV) containing human-bovine (WC3) reassortant rotavirus serotypes G1, G2, G3, and P1a.

STUDY DESIGN

This was a randomized, double-blinded, placebo-controlled trial. During 1993 to 1994, at 10 US study sites, 439 healthy infants approximately 2 to 6 months of age, were enrolled to receive 3 doses of oral QRV or placebo at approximately 8-week intervals.

RESULTS

The vaccine was generally well tolerated; no serious vaccine-related adverse experiences were reported. Risk differences and 95% confidence intervals suggested no differences between vaccine and placebo recipients in the incidences of fever, irritability, vomiting, or diarrhea during the 14 days after any dose. QRV was 74.6% efficacious (95% CI: 49.5%, 88.3%) in preventing rotavirus acute gastroenteritis (AGE), regardless of severity and 100% efficacious (95% CI: 43.5%, 100%) in preventing severe rotavirus AGE through one rotavirus season. Serotype G1 was identified in most infants with rotavirus AGE. A >or=3-fold rise in serum neutralizing antibody to G1 was observed in 57% (45/79) of vaccinees. A >or=3-fold rise in serum anti-rotavirus IgA and fecal anti-rotavirus IgA was observed in 88% (162/185) and 65% (104/159) of vaccinees, respectively.

CONCLUSIONS

QRV was generally well tolerated, immungenic, and highly effective against rotavirus gastroenteritis.

摘要

目的

研究含人 - 牛（WC3）重配轮状病毒血清型G1、G2、G3和P1a的四价活轮状病毒疫苗（QRV）的安全性、有效性和免疫原性。

研究设计

这是一项随机、双盲、安慰剂对照试验。1993年至1994年期间，在美国10个研究地点，招募了约439名2至6个月大的健康婴儿，以大约8周的间隔接受3剂口服QRV或安慰剂。

结果

疫苗总体耐受性良好；未报告与疫苗相关的严重不良事件。风险差异和95%置信区间表明，在任何一剂后的14天内，疫苗接种者和安慰剂接种者在发热、易激惹、呕吐或腹泻的发生率上没有差异。QRV在预防轮状病毒急性胃肠炎（AGE）方面的有效率为74.6%（95%CI：49.5%，88.3%），无论严重程度如何，在一个轮状病毒季节内预防严重轮状病毒AGE的有效率为100%（95%CI：43.5%，100%）。在大多数患有轮状病毒AGE的婴儿中鉴定出G1血清型。57%（45/79）的疫苗接种者血清中针对G1的中和抗体升高≥3倍。分别有88%（162/185）和65%（104/159）的疫苗接种者血清抗轮状病毒IgA和粪便抗轮状病毒IgA升高≥3倍。