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

Evaluation of Intussusception After Oral Monovalent Rotavirus Vaccination in South Africa

Michelle J Groome  1   2 , Jacqueline E Tate  3 , Marion Arnold  4   5 , Milind Chitnis  6 , Sharon Cox  4 , Corné de Vos  5 , Mari Kirsten  7 , Susanna M le Grange  8 , Jerome Loveland  9 , Sello Machaea  6 , Ashwini Maharaj  10 , Nick Andrews  11 , Shabir A Madhi  1   2 , Umesh D Parashar  3
Affiliations

Evaluation of Intussusception After Oral Monovalent Rotavirus Vaccination in South Africa

Michelle J Groome et al. Clin Infect Dis. .

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).

Keywords: infant; intussusception; rotavirus vaccine; safety.

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Figures

Figure 1.
Figure 1.
Age at rotavirus (Rotarix [RV1]) vaccination and at onset of intussusception symptoms among cases.
Figure 2.
Figure 2.
Cases of intussusception occurring during the first 60 days after dose 1 (A) and dose 2 (B) of rotavirus vaccine (Rotarix [RV1]). Three hundred thirteen intussusception cases occurred >60 days after dose 1; 183 cases occurred >60 days after dose 2.
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