Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia 30333, USA.
Clin Infect Dis. 2013 Jul;57(1):13-20. doi: 10.1093/cid/cit164. Epub 2013 Mar 13.
We assessed vaccine effectiveness (VE) for RotaTeq (RV5; 3 doses) and Rotarix (RV1; 2 doses) at reducing rotavirus acute gastroenteritis (AGE) inpatient and emergency department (ED) visits in US children.
We enrolled children <5 years of age hospitalized or visiting the ED with AGE symptoms from November 2009-June 2010 and from November 2010-June 2011 at 7 medical institutions. Fecal specimens were tested for rotavirus by enzyme immunoassay and genotyped. Vaccination among laboratory-confirmed rotavirus cases was compared with rotavirus-negative AGE controls. Regression models calculated VE estimates for each vaccine, age, ethnicity, genotype, and clinical setting.
RV5-specific analyses included 359 rotavirus cases and 1811 rotavirus-negative AGE controls. RV1-specific analyses included 60 rotavirus cases and 155 rotavirus-negative AGE controls. RV5 and RV1 were 84% (95% confidence interval [CI], 78%-88%) and 70% (95% CI, 39%-86%) effective, respectively, against rotavirus-associated ED visits and hospitalizations combined. By clinical setting, RV5 VE against ED and inpatient rotavirus-associated visits was 81% (95% CI, 70%-84%) and 86% (95% CI, 74%-91%), respectively. RV1 was 78% (95% CI, 46%-91%) effective against ED rotavirus disease; study power was insufficient to evaluate inpatient RV1 VE. No waning of immunity was evident during the first 4 years of life for RV5, nor during the first 2 years of life for RV1. RV5 provided genotype-specific protection against each of the predominant strains (G1P[8], G2P[4], G3P[8], G12P[8]), while RV1 VE was statistically significant for the most common genotype, G3P[8].
Both RV5 and RV1 significantly protected against medically attended rotavirus gastroenteritis in this real-world assessment.
我们评估了 RotaTeq（RV5；3 剂）和 Rotarix（RV1；2 剂）在减少美国儿童轮状病毒急性胃肠炎（AGE）住院和急诊（ED）就诊中的疫苗有效性（VE）。
我们招募了 2009 年 11 月至 2010 年 6 月和 2010 年 11 月至 2011 年 6 月期间在 7 家医疗机构因 AGE 症状住院或就诊的<5 岁儿童。通过酶免疫测定法和基因分型检测粪便标本中的轮状病毒。比较实验室确诊的轮状病毒病例与轮状病毒阴性 AGE 对照组的疫苗接种情况。回归模型计算了每种疫苗、年龄、种族、基因型和临床环境的 VE 估计值。
RV5 特异性分析包括 359 例轮状病毒病例和 1811 例轮状病毒阴性 AGE 对照组。RV1 特异性分析包括 60 例轮状病毒病例和 155 例轮状病毒阴性 AGE 对照组。RV5 和 RV1 对 ED 和住院的轮状病毒相关就诊的有效性分别为 84%（95%置信区间[CI]，78%-88%）和 70%（95%CI，39%-86%）。按临床环境划分，RV5 对 ED 和住院的轮状病毒相关就诊的 VE 分别为 81%（95%CI，70%-84%）和 86%（95%CI，74%-91%）。RV1 对 ED 轮状病毒疾病的有效性为 78%（95%CI，46%-91%）；评估 RV1 对住院的 VE 的研究效力不足。在生命的前 4 年，RV5 没有出现免疫力减弱的迹象，在生命的前 2 年，RV1 也没有出现免疫力减弱的迹象。RV5 对每种主要流行株（G1P[8]、G2P[4]、G3P[8]、G12P[8]）均提供了基因型特异性保护，而 RV1 VE 对最常见的基因型 G3P[8]具有统计学意义。
在这项真实世界评估中，RV5 和 RV1 均显著预防了有医疗记录的轮状病毒肠胃炎。
