南非口服单价轮状病毒疫苗接种后肠套叠的评估。

Evaluation of Intussusception After Oral Monovalent Rotavirus Vaccination in South Africa.

机构信息

Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences.

Department of Science and Technology/National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand, Johannesburg, South Africa.

出版信息

Clin Infect Dis. 2020 Apr 10;70(8):1606-1612. doi: 10.1093/cid/ciz431.

DOI:10.1093/cid/ciz431

PMID:31125061

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7146001/

Abstract

BACKGROUND

Postlicensure studies have shown an association between rotavirus vaccination and intussusception. We assessed the risk of intussusception associated with Rotarix (RV1) administration, at 6 and 14 weeks of age, in an upper-middle-income country, South Africa.

METHODS

Active prospective surveillance for intussusception was conducted in 8 hospitals from September 2013 through December 2017. Retrospective case enrollment was done at 1 hospital from July 2012 through August 2013. Demographic characteristics, symptom onset, and rotavirus vaccine status were ascertained. Using the self-controlled case-series method, we estimated age-adjusted incidence rate ratios within 1-7, 8-21, and 1-21 days of rotavirus vaccination in children aged 28-275 days at onset of symptoms. In addition, age-matched controls were enrolled for a subset of cases (n = 169), and a secondary analysis was performed.

RESULTS

Three hundred forty-six cases were included in the case-series analysis. Post-dose 1, there were zero intussusception cases within 1-7 days, and 5 cases within 8-21 days of vaccination. Post-dose 2, 15 cases occurred within 1-7 days, and 18 cases within 8-21 days of vaccination. There was no increased risk of intussusception 1-7 days after dose 1 (no cases observed) or dose 2 (relative incidence [RI], 1.71 [95% confidence interval {CI} .83-3.01]). Similarly, there was no increased risk 8-21 days after the first (RI, 4.01 [95% CI, .87-10.56]) or second dose (RI, .96 [95% CI, .52-1.60]). Results were similar for the case-control analysis.

CONCLUSIONS

The risk of intussusception in the 21 days after the first or second dose of RV1 was not higher than the background risk among South Africa infants.

CLINICAL TRIALS REGISTRATION

South African National Clinical Trial Register (DOH-27-0913-4183).

摘要

背景

疫苗上市后研究表明，轮状病毒疫苗接种与肠套叠之间存在关联。我们评估了在中高收入国家南非，6 周和 14 周龄时接种罗特律克斯（RV1）与肠套叠相关的风险。

方法

2013 年 9 月至 2017 年 12 月，8 家医院开展了肠套叠主动前瞻性监测。2012 年 7 月至 2013 年 8 月，在 1 家医院进行回顾性病例登记。确定人口统计学特征、症状发作和轮状病毒疫苗接种情况。使用自我对照病例系列法，我们估计了接种后 1-7、8-21 和 1-21 天内，接种时年龄为 28-275 天的儿童中，年龄调整的发病率比值。此外，还为部分病例（n=169）招募了年龄匹配的对照，并进行了二次分析。

结果

病例系列分析共纳入 346 例病例。接种第 1 剂后，1-7 天内无肠套叠病例，8-21 天内有 5 例。接种第 2 剂后，1-7 天内有 15 例，8-21 天内有 18 例。第 1 剂后 1-7 天（无观察到病例）或第 2 剂后 1-7 天（相对发病率 [RI]，1.71 [95%置信区间 {CI}.83-3.01]），肠套叠风险无增加。同样，第 1 剂后 8-21 天（RI，4.01 [95% CI，.87-10.56]）或第 2 剂后 8-21 天（RI，.96 [95% CI，.52-1.60]）风险也无增加。病例对照分析结果相似。