Dataset Information

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

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).

SUBMITTER: Groome MJ

PROVIDER: S-EPMC7146001 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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

Groome Michelle J MJ Tate Jacqueline E JE Arnold Marion M Chitnis Milind M Cox Sharon S de Vos Corné C Kirsten Mari M le Grange Susanna M SM Loveland Jerome J Machaea Sello S Maharaj Ashwini A Andrews Nick N Madhi Shabir A SA Parashar Umesh D UD

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 20200401 8

<h4>Background</h4>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.<h4>Methods</h4>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 ...[more]

PMID: 31125061

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Project description:BACKGROUND:A three-dose, oral rotavirus vaccine (Rotavac) was introduced in the universal immunization program in India in 2016. A prelicensure trial involving 6799 infants was not large enough to detect a small increased risk of intussusception. Postmarketing surveillance data would be useful in assessing whether the risk of intussusception would be similar to the risk seen with different rotavirus vaccines used in other countries. METHODS:We conducted a multicenter, hospital-based, active surveillance study at 27 hospitals in India. Infants meeting the Brighton level 1 criteria of radiologic or surgical confirmation of intussusception were enrolled, and rotavirus vaccination was ascertained by means of vaccination records. The relative incidence (incidence during the risk window vs. all other times) of intussusception among infants 28 to 365 days of age within risk windows of 1 to 7 days, 8 to 21 days, and 1 to 21 days after vaccination was evaluated by means of a self-controlled case-series analysis. For a subgroup of patients, a matched case-control analysis was performed, with matching for age, sex, and location. RESULTS:From April 2016 through June 2019, a total of 970 infants with intussusception were enrolled, and 589 infants who were 28 to 365 days of age were included in the self-controlled case-series analysis. The relative incidence of intussusception after the first dose was 0.83 (95% confidence interval [CI], 0.00 to 3.00) in the 1-to-7-day risk window and 0.35 (95% CI, 0.00 to 1.09) in the 8-to-21-day risk window. Similar results were observed after the second dose (relative incidence, 0.86 [95% CI, 0.20 to 2.15] and 1.23 [95% CI, 0.60 to 2.10] in the respective risk windows) and after the third dose (relative incidence, 1.65 [95% CI, 0.82 to 2.64] and 1.08 [95% CI, 0.69 to 1.73], respectively). No increase in intussusception risk was found in the case-control analysis. CONCLUSIONS:The rotavirus vaccine produced in India that we evaluated was not associated with intussusception in Indian infants. (Funded by the Bill and Melinda Gates Foundation and others.).

Project description:Importance:The conclusions from the multiple randomized clinical trials exploring the relationship between development of intussusception and rotavirus vaccination among neonates and infants have been controversial. Objective:To evaluate the association between rotavirus vaccination and risk of intussusception. Data Sources:For this systematic review and meta-analysis, PubMed, Web of Science, Cochrane library, and Embase databases were searched from January 1, 1999, through December 31, 2018, using no language restrictions. The search terms were rotavirus or RV (rotavirus vaccine) or HRV (human rotavirus vaccine), vaccin*, and intussusception. Study Selection:Randomized clinical trials of neonates and infants that compared the risk of intussusception after the vaccination with a placebo group were included. Data Extraction and Synthesis:A fixed-effects model was used to pool the data. Statistical heterogeneity was assessed with Q test and I2 statistic; relative risk (RR), risk difference (RD), and 95% CIs were calculated using the Mantel-Haenszel method. Main Outcomes and Measures:The main outcome was the diagnosis of intussusception in the analysis. The pooled and subtotal results of RR, RD, and 95% CI for the risk of intussusception were estimated at 31 days, 1 year, and 2 years after vaccination. Results:A total of 25 randomized clinical trials including 200?594 participants (104?647 receiving vaccine and 95?947 receiving placebo) in 33 countries from 4 continents were included in this meta-analysis. Twenty cases of definite intussusception were diagnosed within 31 days after rotavirus vaccination, with 11 cases (55%) in the vaccine group and 9 cases (45%) in the placebo group (RD, 0.17 per 10?000 infants [95% CI, -1.16 to 1.50 per 10?000 infants], P?=?.80; RR, 1.14 [95% CI, 0.49 to 2.64], P?=?.77). Seventy-four cases were reported within 1 year, with 37 cases (50%) in the vaccine group and 37 cases (50%) in the placebo group (RD, -0.65 per 10?000 infants [95% CI, -2.68 to 1.39 per 10?000 infants], P?=?.53; RR, 0.84 [95% CI, 0.53 to 1.32], P?=?.45). Fifty-nine cases were reported within 2 years, with 29 cases (49%) in the vaccine group and 30 cases (51%) in the placebo group (RD, -0.48 per 10?000 infants [95% CI, -3.64 to 2.69 per 10?000 infants], P?=?.77; RR, 0.91 [95% CI, 0.55 to 1.52], P?=?.73). Conclusions and Relevance:Results of this systematic review and meta-analysis suggest that monovalent, pentavalent, monovalent human-bovine, oral bovine pentavalent, and human neonatal rotavirus vaccination was not associated with an elevated risk of intussusception among neonates or infants.

Dataset Information

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

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

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