Thomas Inns1,2, Kate M Fleming3, Miren Iturriza-Gomara2,4,5, Daniel Hungerford6,7,8. 1. St Helens and Knowsley Teaching Hospitals NHS Trust, Merseyside, UK. 2. NIHR HPRU in Gastrointestinal Infections at University of Liverpool, Liverpool, UK. 3. Institute of Population Health, University of Liverpool, Liverpool, UK. 4. Department of Clinical Infection, Microbiology and Immunology, University of Liverpool, Liverpool, UK. 5. Centre for Vaccine Innovation and Access, PATH, Geneva, Switzerland. 6. NIHR HPRU in Gastrointestinal Infections at University of Liverpool, Liverpool, UK. d.hungerford@liverpool.ac.uk. 7. Department of Clinical Infection, Microbiology and Immunology, University of Liverpool, Liverpool, UK. d.hungerford@liverpool.ac.uk. 8. Department of Clinical Infection, Microbiology and Immunology, Institute of Infection, Veterinary & Ecological Sciences, University of Liverpool, The Ronald Ross Building, 8 West Derby Street, Liverpool, L69 7BE, UK. d.hungerford@liverpool.ac.uk.
Abstract
BACKGROUND: Rotavirus 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. METHODS: A 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. RESULTS: There 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). CONCLUSIONS: Rotavirus 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.
BACKGROUND:Rotavirus 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. METHODS: A 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. RESULTS: There 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). CONCLUSIONS: Rotavirus 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.
Entities:
Keywords:
Coeliac disease; Cohort study; Infectious disease; Observation study; Rotavirus vaccine; Survival analysis; Type I diabetes; Vaccines
Authors: Lars C Stene; Margo C Honeyman; Edward J Hoffenberg; Joel E Haas; Ronald J Sokol; Lisa Emery; Iman Taki; Jill M Norris; Henry A Erlich; George S Eisenbarth; Marian Rewers Journal: Am J Gastroenterol Date: 2006-10 Impact factor: 10.864
Authors: M C Honeyman; B S Coulson; N L Stone; S A Gellert; P N Goldwater; C E Steele; J J Couper; B D Tait; P G Colman; L C Harrison Journal: Diabetes Date: 2000-08 Impact factor: 9.461
Authors: Christina J Atchison; Julia Stowe; Nick Andrews; Sarah Collins; David J Allen; Sameena Nawaz; David Brown; Mary E Ramsay; Shamez N Ladhani Journal: J Infect Dis Date: 2015-07-30 Impact factor: 5.226
Authors: Daniel James Hungerford; Neil French; Miren Iturriza-Gómara; Jonathan M Read; Nigel A Cunliffe; Roberto Vivancos Journal: J Epidemiol Community Health Date: 2019-09-11 Impact factor: 3.710
Authors: Janet K Snell-Bergeon; Jennifer Smith; Fran Dong; Anna E Barón; Kathy Barriga; Jill M Norris; Marian Rewers Journal: Diabetes Care Date: 2012-10-05 Impact factor: 19.112
Authors: Daniel Hungerford; Roberto Vivancos; Jonathan M Read; Miren Iturriza-Gόmara; Neil French; Nigel A Cunliffe Journal: BMC Med Date: 2018-01-29 Impact factor: 8.775