Dennehy Penelope H, Vesikari Timo, Matson David O, Itzler Robbin F, Dallas Michael J, Goveia Michelle G, DiNubile Mark J, Heaton Penny M, Ciarlet Max
The Alpert Medical School of Brown University and Hasbro Children's Hospital, Providence, RI, USA.
Hum Vaccin. 2011 May;7(5):563-8. doi: 10.4161/hv.7.5.15406. Epub 2011 May 1.
Post-hoc analyses of the Rotavirus Efficacy and Safety Trial (REST) were conducted to determine whether the pentavalent rotavirus vaccine (RV5) confers early protection against rotavirus gastroenteritis (RVGE) before completion of the 3-dose regimen. To evaluate the efficacy of RV5 between doses in reducing the rates of RVGE-related hospitalizations and emergency department (ED) visits in infants who ultimately received all 3 doses of RV5/placebo, events occurring from 2 weeks after the first and second doses to receipt of the subsequent dose (Analysis A) and events occurring from 2 weeks after the first and second doses to 2 weeks after the subsequent dose (Analysis B) were analyzed. In Analysis A, RV5 reduced the rates of combined hospitalizations and ED visits for G1-G4 RVGE or RVGE regardless of serotype between doses 1 and 2 by 100% (95% confidence interval [CI]: 72-100%) or 82% (95% CI: 39-97%), respectively, and between doses 2 and 3, RV5 reduced the rates of combined hospitalizations and ED visits for G1-G4 RVGE or RVGE regardless of serotype by 91% (95% CI: 63-99%) or 84% (95% CI: 54-96%), respectively. Similar rate reductions were observed in Analysis B. These data suggest that RV5 provides a high level of protection between doses against hospitalizations and ED visits for RVGE starting as early as 14 days after the first dose.
开展了轮状病毒有效性和安全性试验（REST）的事后分析，以确定五价轮状病毒疫苗（RV5）在3剂接种方案完成之前是否能对轮状病毒肠胃炎（RVGE）提供早期保护。为了评估在最终接种全部3剂RV5/安慰剂的婴儿中，RV5在各剂之间降低RVGE相关住院率和急诊就诊率的有效性，分析了从第一剂和第二剂接种后2周起至接种后续剂量期间发生的事件（分析A），以及从第一剂和第二剂接种后2周起至后续剂量接种后2周期间发生的事件（分析B）。在分析A中，RV5在第1剂和第2剂之间，使G1 - G4 RVGE或任何血清型的RVGE的住院和急诊就诊合并率分别降低了100%（95%置信区间[CI]：72 - 100%）或82%（95% CI：39 - 97%）；在第2剂和第3剂之间，RV5使G1 - G4 RVGE或任何血清型的RVGE的住院和急诊就诊合并率分别降低了91%（95% CI：63 - 99%）或84%（95% CI：54 - 96%）。在分析B中观察到了类似的率降低情况。这些数据表明，RV5在各剂之间为RVGE的住院和急诊就诊提供了高水平的保护，最早在第一剂接种后14天就开始起效。
