Horizontal transmission of a human rotavirus vaccine strain-A randomized, placebo-controlled study in twins
Horizontal transmission of a human rotavirus vaccine strain-A randomized, placebo-controlled study in twins
复制标题
DOI：
10.1016/j.vaccine.2011.10.015
复制
发表时间：
2011-11-28
期刊：
影响因子：
5.5
通讯作者：
Han, Htay Htay
中科院分区：
文献类型：
--
作者：
Rivera, Luis;Pena, Lourdes Mendez;Han, Htay Htay
在密切接触者中，疫苗衍生的传染性病毒可能从接种疫苗的个体传播给未接种疫苗的个体。这项随机（1：1）、双盲研究评估了人轮状病毒疫苗株HRV（Rotarix（TM））从疫苗接种者传播给未接种疫苗的密切接触者（双胞胎）的可能性。招募了100对在第1剂HRV疫苗/安慰剂时年龄为6-14周的健康双胞胎，每对随机选择一对双胞胎接受两剂疫苗，另一对接受安慰剂剂量（2月龄和4月龄）。在安慰剂接受者的粪便样本中存在疫苗株是传播的指标。在预定的时间点，使用ELISA检测系列粪便样本的轮状病毒;使用RT-PCR和反向杂交试验检测轮状病毒阳性粪便样本，以鉴定G1 P [8]疫苗株。如果检测到G1 P [8]疫苗株，则对全基因组进行测序，以评估病毒分离株之间的相似性。评价了HRV疫苗在传播病例中的免疫原性和安全性。80对接受安慰剂治疗的可评价双胞胎中报告了15例传播病例，传播率为18.8%（95%CI：10.9-29.0%）。没有一宗传播个案与肠胃炎症状有关。第2次给药后7周，抗轮状病毒伊加血清转换率为62.5%（95% CI：51.0-73.1%）（HRV）和21.3%（95% CI：12.9-31.8%）（安慰剂）;传播病例的血清转换率为26.7%（95% CI：7.8-55.1%）。传播病例中的遗传变异或氨基酸替换与相应疫苗接种者中观察到的相似。HRV疫苗株可传播给密切接触的未接种双生子，但与胃肠炎的增加无关。在现阶段，传播是否会在未接种疫苗的个体中产生间接保护仍不清楚。(C)2011爱思唯尔有限公司版权所有。
Transmission of excreted vaccine-derived infectious virus from vaccinated to unvaccinated individuals is possible within close contacts. This randomized (1:1), double-blind study evaluated the potential for transmission of human rotavirus vaccine strain, HRV (Rotarix (TM)) from vaccine recipients to unvaccinated close contacts (twins). 100 pairs of healthy twins aged 6-14 weeks at the time of Dose 1 of HRV vaccine/placebo were enrolled and one randomly selected twin from each pair received two vaccine doses and the other received placebo doses (at 2 and 4 months of age). Presence of vaccine strain in the stool samples of placebo recipients was an indicator of transmission. Serial stool samples were tested for rotavirus using ELISA at pre-determined time points; rotavirus positive stool samples were tested with RT-PCR and reverse hybridization assay to identify G1P[8] vaccine strain. If G1P[8] vaccine strain was detected, the complete genome was sequenced to assess the similarity between viral isolates. Immunogenicity and safety of HRV vaccine in transmission cases was assessed. 15 transmission cases were reported in 80 evaluable twins who received placebo and the transmission rate was 18.8% (95% Cl: 10.9-29.0%). None of the transmission cases was associated with gastroenteritis symptoms. Anti-rotavirus IgA seroconversion was 62.5% (95% CI: 51.0-73.1%) (HRV) and 21.3% (95% CI: 12.9-31.8%) (placebo) 7-weeks post-Dose 2; seroconversion in transmission cases was 26.7% (95% CI: 7.8-55.1%). Genetic variations or amino acid substitutions in transmission cases were similar to that seen in corresponding vaccine recipients. Transmission of HRV vaccine strain to unvaccinated twins living in close contact occurred, however, they were not associated with increased of gastroenteritis. Whether transmission leads to indirect protection among unvaccinated individuals remains unknown at this stage. (C) 2011 Elsevier Ltd. All rights reserved.