Abstract
BackgroundRotavirus infection has been proposed as a risk factor for coeliac disease (CD) and type 1 diabetes (T1D). The UK introduced infant rotavirus vaccination in 2013. We have previously shown that rotavirus vaccination can have beneficial off-target effects on syndromes, such as hospitalised seizures. We therefore investigated whether rotavirus vaccination prevents CD and T1D in the UK.MethodsA cohort study of children born between 2010 and 2015 was conducted using primary care records from the Clinical Practice Research Datalink. Children were followed up from 6 months to 7 years old, with censoring for outcome, death or leaving the practice. CD was defined as diagnosis of CD or the prescription of gluten-free goods. T1D was defined as a T1D diagnosis. The exposure was rotavirus vaccination, defined as one or more doses. Mixed-effects Cox regression was used to estimate hazard ratios (HR) and 95% confidence intervals (CIs). Models were adjusted for potential confounders and included random intercepts for general practices.ResultsThere were 880,629 children in the cohort (48.8% female). A total of 343,113 (39.0%) participants received rotavirus vaccine; among those born after the introduction of rotavirus vaccination, 93.4% were vaccinated. Study participants contributed 4,388,355 person-years, with median follow-up 5.66 person-years. There were 1657 CD cases, an incidence of 38.0 cases per 100,000 person-years. Compared with unvaccinated children, the adjusted HR for a CD was 1.05 (95% CI 0.86–1.28) for vaccinated children. Females had a 40% higher hazard than males. T1D was recorded for 733 participants, an incidence of 17.1 cases per 100,000 person-years. In adjusted analysis, rotavirus vaccination was not associated with risk of T1D (HR = 0.89, 95% CI 0.68–1.19).ConclusionsRotavirus vaccination has reduced diarrhoeal disease morbidity and mortality substantial since licencing in 2006. Our finding from this large cohort study did not provide evidence that rotavirus vaccination prevents CD or T1D, nor is it associated with increased risk, delivering further evidence of rotavirus vaccine safety.
Highlights
Rotavirus infection has been proposed as a risk factor for coeliac disease (CD) and type 1 diabetes (T1D)
We aimed to address the uncertainty in the evidence around these potential associations by researching whether children born in England between 2010 and 2015 who received rotavirus vaccination (Rotarix®) have a different risk of developing CD and T1D than those without this vaccination
Study participants The study dataset extracted from Clinical Practice Research Datalink (CPRD) Aurum contained 926,013 participants
Summary
Rotavirus infection has been proposed as a risk factor for coeliac disease (CD) and type 1 diabetes (T1D). The incidence rate of T1D for children in England and Wales was estimated to be 24.5 cases per 100, 000 per year in 2018/19, with incidence peaking in those under 5 years of age and again during puberty [4, 5]. Both CD and T1D have a complex aetiology, which include strong genetic risk factors for susceptibility, as well as environmental exposures being influential. One such possible risk factor for both is rotavirus infection
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