Dataset Information

Safety study of live, oral human rotavirus vaccine: A cohort study in United States health insurance plans.

ABSTRACT: As part of a regulatory commitment for post-licensure safety monitoring of live, oral human rotavirus vaccine (RV1), this study compared the incidence rates (IR) of intussusception, acute lower respiratory tract infection (LRTI) hospitalization, Kawasaki disease, convulsion, and mortality in RV1 recipients versus inactivated poliovirus vaccine (IPV) recipients in concurrent (cIPV) and recent historical (hIPV) comparison cohorts. Vaccine recipients were identified in 2 claims databases from August 2008 - June 2013 (RV1 and cIPV) and January 2004 - July 2008 (hIPV). Outcomes were identified in the 0-59 days following the first 2 vaccine doses. Intussusception, Kawasaki disease, and convulsion were confirmed via medical record review. Outcome IRs were estimated. Incidence rate ratios (IRRs) were obtained from Poisson regression models. A post-hoc self-controlled case series (SCCS) analysis compared convulsion IRs in a 0-7 day post-vaccination period to a 15-30 day post-vaccination period. We identified 57,931 RV1, 173,384 cIPV, and 159,344 hIPV recipients. No increased risks for intussusception, LRTI, Kawasaki disease, or mortality were observed. The convulsion IRRs were elevated following RV1 Dose 1 (cIPV: 2.07, 95% confidence interval [CI]: 1.27 - 3.38; hIPV: 2.05, 95% CI: 1.24 - 3.38), a finding which is inconclusive as it was observed in only one of the claims databases. The IRR following RV1 Dose 1 in the SCCS analysis lacked precision (2.40, 95% CI: 0.73 - 7.86). No increased convulsion risk was observed following RV1 Dose 2. Overall, this study supports the favorable safety profile of RV1. Continued monitoring for safety signals through routine surveillance is needed to ensure vaccine safety.

SUBMITTER: Hoffman V

PROVIDER: S-EPMC6067866 | biostudies-other | 2018 Jul

REPOSITORIES: biostudies-other

ACCESS DATA

Publications

Safety study of live, oral human rotavirus vaccine: A cohort study in United States health insurance plans.

Hoffman Veena V Abu-Elyazeed Remon R Enger Cheryl C Esposito Daina B DB Doherty Michael C MC Quinlan Scott C SC Skerry Kathleen K Holick Crystal N CN Basile Peter P Friedland Leonard R LR Praet Nicolas N Wéry Stéphanie S Willame Corinne C Dore David D DD Rosillon Dominique D

Human vaccines & immunotherapeutics 20180413 7

As part of a regulatory commitment for post-licensure safety monitoring of live, oral human rotavirus vaccine (RV1), this study compared the incidence rates (IR) of intussusception, acute lower respiratory tract infection (LRTI) hospitalization, Kawasaki disease, convulsion, and mortality in RV1 recipients versus inactivated poliovirus vaccine (IPV) recipients in concurrent (cIPV) and recent historical (hIPV) comparison cohorts. Vaccine recipients were identified in 2 claims databases from Augus ...[more]

PMID: 29533129

Similar Datasets

Project description:BackgroundPrior to vaccine introduction in 2006, rotavirus was the leading cause of severe diarrhea in children under five years of age in the U.S. Vaccination of infants has led to major reductions in disease burden, a shift in the seasonal peak and the emergence of a biennial pattern of disease. However, rotavirus vaccine coverage has remained relatively low (70-75%) compared to other infant immunizations in the U.S. Part of the reason for this lower coverage is that children whose care is provided by family practitioners (FP) have considerably lower probability of being vaccinated compared to those seen be pediatricians (PE). We used a dynamic transmission model to assess the impact of improving rotavirus vaccine coverage by FP and/or PE on rotavirus gastroenteritis (RVGE) incidence and seasonal patterns.MethodsA deterministic age-structured dynamic model with susceptible, infectious, and recovered compartments (SIRS model) was used to simulate rotavirus transmission and vaccination. We estimated the reduction of RVGE cases by 2 doses of rotavirus vaccine with three vaccination scenarios: (Status Quo: 85% coverage by pediatricians and 45% coverage by family practitioners; Improved FP: 85% coverage by pediatricians and family practitioners; Improved FP+PE: 95% coverage by pediatricians and family practitioners). In addition, we tested the sensitivity of the model to the assumption of random mixing patterns between children visiting pediatricians and children visiting family practitioners.ResultsIn this model, higher vaccine coverage provided by family practitioners and pediatricians leads to lower incidence of severe RVGE cases (23% averted in Improved FP and 57% averted in Improved FP+PE compared to Status Quo) including indirect effects. One critical impact of higher total vaccine coverage is the effect on rotavirus epidemic patterns in the U.S.; the biennial rotavirus epidemic patterns shifted to reduced annual epidemic patterns. Additionally, assortative mixing patterns in children visiting pediatricians and family practitioners amplify the impact of increasing vaccine coverage.ConclusionOther high-income countries that introduced vaccine have not experienced biennial patterns, like the U.S. Our results suggest that increasing overall vaccine coverage to 85% among infants would lead to an overall reduction in incidence with annual epidemic patterns.

Project description:BackgroundRotavirus vaccines are now globally recommended by the World Health Organization (WHO), but in early 2009 WHO's Strategic Advisory Group of Experts on Immunization reviewed available data and concluded that there was no evidence for the efficacy or effectiveness of a two-dose schedule of the human rotavirus vaccine (HRV; Rotarix) given early at 6 and 10 wk of age. Additionally, the effectiveness of programmatic rotavirus vaccination, including possible indirect effects, has not been assessed in low-resource populations in Asia.Methods and findingsIn Bangladesh, we cluster-randomized (1:1) 142 villages of the Matlab Health and Demographic Surveillance System to include two doses of HRV with the standard infant vaccines at 6 and 10 wk of age or to provide standard infant vaccines without HRV. The study was initiated November 1, 2008, and surveillance was conducted concurrently at Matlab Diarrhoea Hospital and two community treatment centers to identify children less than 2 y of age presenting with acute rotavirus diarrhea (ARD) through March 31, 2011. Laboratory confirmation was made by enzyme immunoassay detection of rotavirus antigen in stool specimens. Overall effectiveness of the HRV vaccination program (primary objective) was measured by comparing the incidence rate of ARD among all children age-eligible for vaccination in villages where HRV was introduced to that among such children in villages where HRV was not introduced. Total effectiveness among vaccinees and indirect effectiveness were also evaluated. In all, 6,527 infants were age-eligible for vaccination in 71 HRV villages, and 5,791 in 71 non-HRV villages. In HRV villages, 4,808 (73.7%) infants received at least one dose of HRV. The incidence rate of ARD was 4.10 cases per 100 person-years in non-HRV villages compared to 2.8 per 100 person-years in HRV villages, indicating an overall effectiveness of 29.0% (95% CI, 11.3% to 43.1%). The total effectiveness of HRV against ARD among vaccinees was 41.4% (95% CI, 23.2% to 55.2%). The point estimate for total effectiveness was higher against ARD during the first year of life than during the second (45.2% versus 28.9%), but estimates for the second year of life lacked precision and did not reach statistical significance. Indirect effects were not detected. To check for bias in presentation to treatment facilities, we evaluated the effectiveness of HRV against acute diarrhea associated with enterotoxigenic Escherichia coli; it was 4.0% (95% CI, -46.5% to 37.1%), indicating that bias likely was not introduced. Thirteen serious adverse events were identified among recipients of HRV, but none were considered related to receipt of study vaccine. The main limitation of this study is that it was an open-label study with an observed-only control group (no placebo).ConclusionsThe two-dose HRV rotavirus vaccination program significantly reduced medically attended ARD in this low-resource population in Asia. Protection among vaccinees was similar to that in other low-resource settings. In low-resource populations with high rotavirus incidence, large-scale vaccination across a wide population may be required to obtain the full benefit of rotavirus vaccination, including indirect effects.Trial registrationClinicalTrials.gov NCT00737503.

Dataset Information

Safety study of live, oral human rotavirus vaccine: A cohort study in United States health insurance plans.

Publications

Safety study of live, oral human rotavirus vaccine: A cohort study in United States health insurance plans.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets