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Association Between Rotavirus Vaccination and Risk of Intussusception Among Neonates and Infants: A Systematic Review and Meta-analysis.

ABSTRACT: 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.

SUBMITTER: Lu HL

PROVIDER: S-EPMC6784808 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Association Between Rotavirus Vaccination and Risk of Intussusception Among Neonates and Infants: A Systematic Review and Meta-analysis.

Lu Hai-Ling HL Ding Ying Y Goyal Hemant H Xu Hua-Guo HG

JAMA network open 20191002 10

<h4>Importance</h4>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.<h4>Objective</h4>To evaluate the association between rotavirus vaccination and risk of intussusception.<h4>Data sources</h4>For this systematic review and meta-analysis, PubMed, Web of Science, Cochrane library, and Embase databases were searched from January 1, 1999, through ...[more]

PMID: 31584679

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Project description:BackgroundIntussusception is a prevalent pediatric issue causing acute abdominal pain, with potential links to rotavirus vaccines. The variety of these vaccines has grown in recent years. This meta-analysis study aims to evaluate the impact of various rotavirus vaccines on intussusception incidence.MethodsWe executed a thorough search across databases like PubMed, Cochrane Library, Embase, and Web of Science, leading to the selection of 15 credible randomized controlled trials (RCTs) that encompass various types of rotavirus vaccines. From each study, we extracted essential details such as vaccine types and intussusception occurrences. We assessed the risk of bias using the Cochrane Collaboration's tool, conducted statistical analysis with R (version 4.2.3), determined relative risk (RR) using a random effects model, and performed a subgroup analysis for vaccines of differing brands and types.ResultsWe included 15 randomized controlled studies from various countries. While intussusception incidence differed between vaccinated and control groups, this difference was not statistically significant. The overall risk ratio (RR), calculated using a random effects model, was 0.81, with a 95% confidence interval of [0.53, 1.23]. This crossing 1 shows that vaccination didn't notably change disease risk. Additionally, the 0% group heterogeneity suggests consistency across studies, strengthening our conclusions. Subgroup analysis for different vaccine brands and types (RV1 (Rotarix, Rotavac, RV3-BB), RV3 (LLR3), RV5 (RotasiiL, RotaTeq), and RV6) showed no significant variation in intussusception incidence. Despite variations in RR among subgroups, these differences were not statistically significant (P > 0.05).ConclusionsOur study indicates that rotavirus vaccination does not significantly increase the incidence of intussusception. Despite varying impacts across different vaccine brands and types, these variations are insignificant. Given the substantial benefits outweighing the risks, promoting the use of newly developed rotavirus vaccines remains highly valuable.Systematic review registrationwww.crd.york.ac.uk/prospero/, Identifier CRD42023425279.

Project description:ImportanceBecause rotavirus infection is a hypothesized risk factor for type 1 diabetes, live attenuated rotavirus vaccination could increase or decrease the risk of type 1 diabetes in children.ObjectiveTo examine whether there is an association between rotavirus vaccination and incidence of type 1 diabetes in children aged 8 months to 11 years.Design, setting, and participantsA retrospective cohort study of 386 937 children born between January 1, 2006, and December 31, 2014, was conducted in 7 US health care organizations of the Vaccine Safety Datalink. Eligible children were followed up until a diagnosis of type 1 diabetes, disenrollment, or December 31, 2017.ExposuresRotavirus vaccination for children aged 2 to 8 months. Three exposure groups were created. The first group included children who received all recommended doses of rotavirus vaccine by 8 months of age (fully exposed to rotavirus vaccination). The second group had received some, but not all, recommended rotavirus vaccines (partially exposed to rotavirus vaccination). The third group did not receive any doses of rotavirus vaccines (unexposed to rotavirus vaccination).Main outcomes and measuresIncidence of type 1 diabetes among children aged 8 months to 11 years. Type 1 diabetes was identified by International Classification of Diseases codes: 250.x1, 250.x3, or E10.xx in the outpatient setting. Cox proportional hazards regression models were used to analyze time to type 1 diabetes incidence from 8 months to 11 years. Hazard ratios and 95% CIs were calculated. Models were adjusted for sex, race/ethnicity, birth year, mother's age, birth weight, gestational age, number of well-child visits, and Vaccine Safety Datalink site.ResultsIn a cohort of 386 937 children (51.1% boys and 41.9% non-Hispanic white), 360 169 (93.1%) were fully exposed to rotavirus vaccination, 15 765 (4.1%) were partially exposed to rotavirus vaccination, and 11 003 (2.8%) were unexposed to rotavirus vaccination. Children were followed up a median of 5.4 years (interquartile range, 3.8-7.8 years). The total person-time follow-up in the cohort was 2 253 879 years. There were 464 cases of type 1 diabetes in the cohort, with an incidence rate of 20.6 cases per 100 000 person-years. Compared with children unexposed to rotavirus vaccination, the adjusted hazard ratio was 1.03 (95% CI, 0.62-1.72) for children fully exposed to rotavirus vaccination and 1.50 (95% CI, 0.81-2.77) for children partially exposed to rotavirus vaccination.Conclusions and relevanceThe findings of this study suggest that rotavirus vaccination does not appear to be associated with type 1 diabetes in children.

Project description:BackgroundThe cost-effectiveness of universal rotavirus (RV) vaccination is controversial in developed countries. As a result, RV vaccination programs do not currently exist in most European countries. Hospitalization is the main driver of RV disease costs, and prematurity, low birth weight (LBW) and underlying medical conditions have been associated with RV hospitalization and complications. We investigated the cost-effectiveness of targeted RV vaccination of high-risk infants and universal RV vaccination versus no vaccination.MethodsDisease burden, mortality and healthcare costs of RV hospitalization for children with and without prematurity, LBW and congenital pathology were quantified in two hospital-based observational studies in the Netherlands. Cost-effectiveness analysis was based on an age-structured stochastic multi-cohort model of the Dutch population comparing universal RV vaccination and targeted vaccination of high-risk infants to no vaccination. The primary endpoint was the incremental cost-effectiveness ratio (ICER), with a threshold of €35,000/quality-adjusted life year (QALY) from the healthcare provider perspective. Sensitivity analyses included vaccine price and coverage, herd-immunity and QALY losses.ResultsA total of 936 children with RV infection were included. Prematurity, LBW and congenital pathology were associated with increased risks of RV hospitalization (relative risks (RR) ranging from 1.6 to 4.4), ICU admission (RR ranging from 4.2 to 7.9), prolonged hospital stay (1.5 to 3.0 excess days) and higher healthcare costs (€648 to €1,533 excess costs). Seven children succumbed due to RV complications, all belonging to the high-risk population. Targeted RV vaccination was highly cost-effective and potentially cost-saving from the healthcare provider perspective with ICERs below €20,000/QALY in all scenarios with total (undiscounted) annual healthcare costs between -€0.1 and €0.5 million/year. Results were most sensitive to mortality rates, but targeted vaccination remained highly cost-effective up to reductions of 90% compared to observed mortality. Universal RV vaccination was not considered cost-effective (mean ICER: €60,200/QALY) unless herd-immunity and caretaker QALY losses were included and vaccine prices were €60 at most (mean ICER: €21,309/QALY).ConclusionWe recommend targeted RV vaccination for high-risk infants in developed countries.

Dataset Information

Association Between Rotavirus Vaccination and Risk of Intussusception Among Neonates and Infants: A Systematic Review and Meta-analysis.

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Association Between Rotavirus Vaccination and Risk of Intussusception Among Neonates and Infants: A Systematic Review and Meta-analysis.

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