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Timing of Rotavirus Vaccine Doses and Severe Rotavirus Gastroenteritis Among Vaccinated Infants in Low- and Middle-income Countries.

ABSTRACT: BACKGROUND:Altering rotavirus vaccine schedules may improve vaccine performance in low- and middle-income countries. We analyzed data from clinical trials of the monovalent (RV1) and pentavalent (RV5) rotavirus vaccines in low- and middle-income countries to understand the association between vaccine dose timing and severe rotavirus gastroenteritis incidence. METHODS:We assessed the association between variations in rotavirus vaccine administration schedules and severe rotavirus gastroenteritis risk. We used the complement of the Kaplan-Meier survival estimator to estimate risk differences for different schedules. To adjust risk differences (RDs) for confounding, we calibrated estimates in the vaccinated arm using estimates from the placebo arm. RESULTS:There were 3,114 and 7,341 children included from the RV1 and RV5 trials, respectively. The 18-month adjusted severe rotavirus gastroenteritis risk was 4.0% (95% confidence interval [CI] = 1.1, 7.1) higher for those receiving their first RV5 dose at <6 versus ?6 weeks. For RV1, there was a 4.0% (95% CI = 0.0, 8.2) increase in 12-month adjusted risk for a 4- versus 6-week interval between doses. Further analysis revealed those receiving their first RV5 dose at 3-4 and 5-7 weeks had 2.9% (95% CI = 0.8, 5.3) and 1.3% (95% CI = -0.3, 3.0), respectively, higher risk compared with those at 9-12 weeks. Those receiving their first dose at 8 weeks had the lowest risk (RD: -2.6% [95% CI = -5.4, -0.1]) compared with those at 9-12 weeks. CONCLUSIONS:A modest delay in rotavirus vaccination start and increase in interval between doses may be associated with lower severe rotavirus gastroenteritis risk in low- and middle-income countries.

SUBMITTER: Gruber JF

PROVIDER: S-EPMC6167161 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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Timing of Rotavirus Vaccine Doses and Severe Rotavirus Gastroenteritis Among Vaccinated Infants in Low- and Middle-income Countries.

Gruber Joann F JF Becker-Dreps Sylvia S Hudgens Michael G MG Brookhart M Alan MA Thomas James C JC Jonsson Funk Michele M

Epidemiology (Cambridge, Mass.) 20181101 6

<h4>Background</h4>Altering rotavirus vaccine schedules may improve vaccine performance in low- and middle-income countries. We analyzed data from clinical trials of the monovalent (RV1) and pentavalent (RV5) rotavirus vaccines in low- and middle-income countries to understand the association between vaccine dose timing and severe rotavirus gastroenteritis incidence.<h4>Methods</h4>We assessed the association between variations in rotavirus vaccine administration schedules and severe rotavirus g ...[more]

PMID: 30074540

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Project description:BackgroundLive oral rotavirus vaccines (LORVs) have significantly reduced rotavirus hospitalizations and deaths worldwide. However, LORVs are less effective in low- and middle-income countries (LMICs). Next-generation rotavirus vaccines (NGRVs) may be more effective but require administration by injection or a neonatal oral dose, adding operational complexity. Healthcare providers (HPs) were interviewed to assess rotavirus vaccine preferences and identify delivery issues as part of an NGRV value proposition.ObjectiveDetermine HP vaccine preferences about delivering LORVs compared to injectable (iNGRV) and neonatal oral (oNGRV) NGRVs.Methods64 HPs from Ghana, Kenya, Malawi, Peru, and Senegal were interviewed following a mixed-method guide centered on three vaccine comparisons: LORV vs. iNGRV; LORV vs. oNGRV; oNGRV vs. iNGRV. HPs reviewed attributes for each vaccine in the comparisons, then indicated and explained their preference. Additional questions elicited views about co-administering iNGRV+LORV for greater public health impact, a possible iNGRV-DTP-containing combination vaccine, and delivering neonatal doses.ResultsAlmost all HPs preferred oral vaccine options over iNGRV, with many emphasizing an aversion to additional injections. Despite this strong preference, HPs described challenges delivering oral doses. Preferences for LORV vs. oNGRV were split, marked by disparate views on rotavirus disease epidemiology and the safety, need, and feasibility of delivering neonatal vaccines. Although overwhelmingly enthusiastic about an iNGRV-DTP-containing combination option, several HPs had concerns. HP views were divided on the feasibility of co-administering iNGRV+LORV, citing challenges around logistics and caregiver sensitization.ConclusionOur findings provide valuable insights on delivering NGRVs in routine immunization. Despite opposition to injectables, openness to co-administering LORV+iNGRV to improve efficacy suggests future HP support of iNGRV if adequately informed of its advantages. Rationales for LORV vs. oNGRV underscore needs for training on rotavirus epidemiology and stronger service integration. Expressed challenges delivering existing LORVs merit further examination and indicate need for improved delivery.

Project description:Background: Babies born weighing???2500 g account for more than 80% of the births in most resource-limited locations and for nearly 50% of the 28-day neonatal deaths. In contrast, in high-resource settings, 28-day neonatal mortality among this group represents only a small fraction of the neonatal deaths. Yet mortality risks for birth weight of???2500 g is limited. Knowledge regarding the factors associated with mortality in these babies will help in identifying interventions that can reduce mortality.Methods: The Global Network's Maternal Newborn Health Registry (MNHR) is a prospective, population-based observational study that includes all pregnant women and their pregnancy outcomes in defined geographic communities that has been conducted in research sites in six low-middle income countries (India, Pakistan, Democratic Republic of Congo, Guatemala, Kenya and Zambia). Study staff enroll all pregnant women as early as possible during pregnancy and conduct follow-up visits to ascertain delivery and 28-day neonatal outcomes. We analyzed the neonatal mortality rates (NMR) and risk factors for deaths by 28 days among all live-born babies with a birthweight???2500 g from 2010 to 2018 across the Global Network sites.Results: Babies born in the Global Network sites from 2010 to 2018 with a birthweight???2500 g accounted for 84.8% of the births and 45.4% of the 28-day neonatal deaths. Among this group, the overall NMR was 13.1/1000 live births. The overall 28-day NMR for ongoing clusters was highest in Pakistan (29.7/1000 live births) and lowest in the Zambian/Kenyan sites (9.3/1000) for???2500 g infants.???2500 g NMRs declined for Zambia/Kenya and India. For Pakistan and Guatemala, the NMR remained almost unchanged over the period. The???2500 g risks related to maternal, delivery and newborn characteristics varied by site. Maternal factors that increased risk and were common for all sites included nulliparity, hypertensive disease, previous stillbirth, maternal death, obstructed labor, severe postpartum hemorrhage, and abnormal fetal presentation. Neonatal characteristics including resuscitation, hospitalization, congenital anomalies and male sex, as well as lower gestational ages and birthweights were also associated with increased mortality.Conclusions: Nearly half of neonatal deaths in the Global Network sites occurred in infants born weighing???2500 g. The NMR for those infants was 13.1 per 1000 live births, much higher than rates usually seen in high-income countries. The changes in NMR over time varied across the sites. Even among babies born???2500 g, lower gestational age and birthweight were largely associated with increased risk of mortality. Since many of these deaths should be preventable, attention to preventing mortality in these infants should have an important impact on overall NMR.Trial registration: https://ClinicalTrials.gov Identifier: NCT01073475.

Project description:ImportanceSince 2000, the Lanzhou lamb rotavirus vaccine has been exclusively licensed in China for voluntary rotavirus gastroenteritis (RV-GE) prevention.ObjectiveTo evaluate the association of the Lanzhou lamb rotavirus vaccination with RV-GE among children in southern China.Design, setting, and participantsThis cross-sectional, ecological study was set in Guangzhou, China. Participants were infants possibly vaccinated (aged 2 months to 3 years) and the children ineligible for vaccination (aged ≥4 years). The study was conducted from May 1, 2007, to April 30, 2016, and the data analysis was conducted in July 2016.Main outcomes and measuresAnnual median age at onset of RV-GE and seasonal distribution of incidence. Cases of RV-GE in Guangzhou, China, diagnosed from May 1, 2007, to April 30, 2016, and reported to the National Information System for Disease Control and Prevention were examined. Poisson regression models were fitted among 32 452 children younger than 4 years and among 450 children who had been ineligible for vaccination, while controlling for secular trends, socioeconomic status, and meteorological factors. Logistic regression was used to assess the indirect effects provided by the vaccinated infants from 2009 to 2011 on unvaccinated infants aged 2 to 35 months based on a separate case-control data set.ResultsDuring 9 seasons, 119 705 patients with gastroenteritis were reported; 33 407 were confirmed for RV-GE (21 202 [63.5%] male, 32 022 [95.8%] aged <4 years, and 31 306 [93.8%] residing in urban districts). The median age at onset for all patients with RV-GE increased from 11 months during the 2007 season to 15 months during the 2015 season, and the onset, peak, and cessation of incidence were delayed. When citywide vaccination coverage in the prior 12 months was classified into high and low groups (≥8.36% vs <8.36%), the incidence rate ratio for the high coverage group decreased by 32.4% among children younger than 4 years (incidence rate ratio, 0.676; 95% CI, 0.659-0.693; P < .001). Among the children ineligible for vaccination, the incidence rate ratio in higher coverage periods was 0.790 (95% CI, 0.351-0.915; P < .001) compared with the lower coverage. Compared with districts with 14% or less vaccination coverage, the adjusted odds ratio for RV-GE among unvaccinated children younger than 3 years was 0.85 (95% CI, 0.73-0.99; P = .03) for districts with 15% to 19% of coverage, and 0.79 (95% CI, 0.67-0.93; P = .004) for districts with more than 20% of coverage.Conclusions and relevanceThis study provides evidence of the population health benefits of the Lanzhou lamb rotavirus vaccination in preventing RV-GE among children in China younger than 4 years, including herd effects.

Dataset Information

Timing of Rotavirus Vaccine Doses and Severe Rotavirus Gastroenteritis Among Vaccinated Infants in Low- and Middle-income Countries.

Publications

Timing of Rotavirus Vaccine Doses and Severe Rotavirus Gastroenteritis Among Vaccinated Infants in Low- and Middle-income Countries.

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