Noninterference of Rotavirus Vaccine With Measles-Rubella Vaccine at 9 Months of Age and Improvements in Antirotavirus Immunity: A Randomized Trial

Zaman, Khalequ; Fleming, Jessica A.; Victor, John C.; Yunus, Muhammad; Bari, Tajul I; Azim, Tasnim; Rahman, Mustafizur; Mowla, Syed Mohammad Niaz; Bellini, William J.; McNeal, Monica; Icenogle, Joseph P.; Lopman, Ben; Parashar, Umesh D.; Cortese, Margaret M.; Steele, A. Duncan; Neuzil, Kathleen M.

doi:10.1093/infdis/jiw024

Cited by 43 publications

(44 citation statements)

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“…Second, following the successful strategy applied to the measles vaccine, a modified RV schedule or additional doses of vaccine when maternal antibody has waned may improve vaccine responsiveness. In fact, studies of the monovalent RV from Ghana, South Africa, and Bangladesh all suggest a benefit of this strategy (84)(85)(86). These studies showed benefits in immunogenicity of delaying the first dose of RV from 6 until 10 weeks of life and adding a third dose of RV either at 14 weeks or at 9 months of age.…”

Section: Discussionmentioning

confidence: 99%

Contribution of Maternal Immunity to Decreased Rotavirus Vaccine Performance in Low- and Middle-Income Countries

Mwila

Chilengi

Simuyandi

et al. 2017

Clin Vaccine Immunol

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The role of maternal immunity, received by infants either transplacentally or orally from breast milk, in rotavirus vaccine (RV) performance is evaluated here. Breastfeeding withholding has no effect on vaccine responses, but higher levels of transplacental rotavirus-specific IgG antibody contribute to reduced vaccine seroconversion. The gaps in knowledge on the factors associated with low RV efficacy in low-and middle-income countries (LMIC) remain, and further research is needed to shed more light on these issues. KEYWORDS immunization, low-and middle-income countries, maternal, rotavirus D espite the progress seen with the global introduction of rotavirus vaccines (RV), diarrhea is still a leading cause of death in children under the age of 5 years, and a substantial proportion of disease cases are still attributable to rotavirus infection. The latest estimates show that approximately 215,000 children die each year from rotavirusassociated diarrhea, and approximately 56% of these deaths are in sub-Saharan Africa (1). The World Health Organization (WHO) recommended the introduction of oral RV into national immunization programs (2), and many countries have heeded this call. As of September 2016, the WHO lists 86 countries as having included RV in their national immunization programs, and 6 more are in the course of doing so in 2016 (www.who.int/immunization/monitoring_surveillance/VaccineIntroStatus.pptx). Approximately 50% of the countries in Africa and Asia, over 80% of those in North America, South America, and Australia, and approximately 40% of those in Europe have introduced RV. Following RV introduction, there was a notable reduction in the number of deaths due to diarrhea (1). However, there is consistent evidence from clinical trials that RV have lower efficacies in low-and middle-income countries (LMIC): vaccine efficacies are 80 to 90% in high-income countries (HIC) and 40 to 60% in LMIC (3-8). Indeed, there is growing evidence from vaccine effectiveness studies emerging from the field that in real-life use, vaccine effectiveness is also consistently lower in LMIC (9-12).In addition to the differences in observed vaccine efficacy and effectiveness, there are also marked differences in vaccine-elicited immunity as reported by various vaccine-elicited antibody titers following rotavirus immunization (13)(14)(15)(16)(17)(18). A number of hypotheses have been put forward to explain the differences in efficacy and vaccineelicited immunity between HIC and LMIC. The hypotheses include (i) maternal factors (such as interference from transplacental antibodies and antibody and nonantibody breast milk components [13,[19][20][21][22][23] [38,39]). A better understanding of these factors which decrease the efficacy of RV in LMIC may help to inform interventions to improve efficacy and to further reduce the number of child deaths due to rotavirus disease. This review examines the correlations between maternal immune factors and RV responses and their potential effect on vaccine efficacy. NATURAL ROTAVIRUS...

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Section: Discussionmentioning

confidence: 99%

Contribution of Maternal Immunity to Decreased Rotavirus Vaccine Performance in Low- and Middle-Income Countries

Mwila

Chilengi

Simuyandi

et al. 2017

Clin Vaccine Immunol

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“…The total female population size (33,976,774 for 2013) and the proportion of DRC's population living in urban 206 and rural settings (35.4% and 64.6% respectively for 2013) were extracted from United Nations (UN) population 207 sources, and the two were multiplied together to obtain the number of females living in urban and rural areas in 208 DRC [20,21]. These numbers were then scaled up by 28%, to account for a 28% difference between the 209 population size according to UN sources and that in the DRC EPI-MOPH projections for 2013 (67,513,677 vs 210 86,508,633, respectively).…”

Section: Estimating Crs Incidence and The Number Of Crs Cases Born Inmentioning

confidence: 99%

“…The 14 women with equivocal determination were distributed among 4 study sites as follows: Mikalayi 167 (n=6, ages in years=17, 19,22,23,37,38), Vanga (n=1, age in years =34), Tshikapa (n=4, ages in years=17, 29, 34, 168 35), and Kinshasa (n=3, ages in years=17, 17, 18). Immune individuals with ELISA-determined IgG <10 IU/ml 169 should be too small in number to affect the results presented in this report [20]. 170…”

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confidence: 94%

Estimating the burden of rubella virus infection and congenital rubella syndrome through a rubella immunity assessment among pregnant women in the Democratic Republic of the Congo: Potential impact on vaccination policy

Alleman

Wannemuehler

Hao

et al. 2016

Vaccine

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A rubella antibody seroprevalence assessment was conducted using serum collected during 2008-2009 from 1,605 pregnant women aged 15-46 years attending 7 antenatal care sites in 3 of DRC's provinces. Estimates of age-and site-specific rubella antibody seroprevalence, population, and fertility rates were used in catalytic models to estimate the incidence of CRS per 100,000 live births and the number of CRS cases born in 2013 in DRC.Overall 84% (95% CI 82, 86) of the women tested were estimated to be rubella antibody seropositive. The association between age and estimated antibody seroprevalence, adjusting for study site, was not significant (p=0.10). Differences in overall estimated seroprevalence by study site were observed indicating variation by geographical area (p<=0.03 for all). Estimated seroprevalence was similar for women declaring residence in urban (84%) versus rural (83%) settings (p=0.67). In 2013 for DRC nationally, the estimated incidence of CRS was 69/100,000 live births (95% CI 0, 186), corresponding to 2886 infants (95% CI 342, 6395) born with CRS.In the 3 provinces, rubella virus transmission is endemic, and most viral exposure and seroconversion occurs before age 15 years. However, approximately 10%-20% of the women were susceptible to rubella virus infection and thus at risk for having an infant with CRS. Per World Health Organization recommendations, introduction of RCV should be accompanied by a campaign targeting children 9 months to 14 years and vaccination of women of child bearing age through routine services. Please find below our responses (in italics in blue below each reviewer's comments) to the comments and the details describing how the manuscript was revised to address each.Reviewer #1: This manuscript provides estimates of Congenital Rubella Syndrome (CRS) for the Democratic Republic of Congo (DRC) using seroprevalence data obtained from existing blood specimens from antenatal clinics. It provides an idea of the occurrence of CRS in a country with little rubella data and that has not yet introduced a rubella-containing vaccine, thus shedding light on an issue that is relevant when discussing vaccine introduction and vaccination strategies. The paper is well written and the supplemental material useful to understand the models used.Specific comments: Abstract 1. What % of the population live in the selected provinces 193-199, lines 206-211, and lines 252-257). Additional details regarding a number of elements of DRC's population have been incorporated into the Methods section of the manuscript (Please see lines Clarify that the estimated CRS incidence and cases in 2013 is for all of DRCThe abstract has been revised to read "In 2013 for DRC nationally, the estimated incidence of CRS was 69/100,000 live births (95% CI 0, 186), corresponding to 2886 infants (95% CI 342, 6395) born with CRS."

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“…Despite efforts to study the interactions between commensal bacteria and host immune responses, the role of the intestinal microbiota on vaccine response remains underinvestigated, especially in heterogeneous populations. Evaluation of immunogenicity of oral RV vaccines given with OPV and potential for interference have been described from Bangladesh, but not with vaccination on a routine immunisation schedule 49. This study will evaluate performance of the RV vaccine in the routine schedule in two developing counties where OPV may be soon phased out to be replaced with IPV as per the Global Polio Eradication Initiative (GPEI) Strategic Plan for 2013–2018.…”

Section: Discussionmentioning

confidence: 99%

Impact of maternal antibodies and infant gut microbiota on the immunogenicity of rotavirus vaccines in African, Indian and European infants: protocol for a prospective cohort study

et al. 2017

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IntroductionGastroenteritis is the leading cause of morbidity and mortality among young children living in resource-poor settings, majority of which is attributed to rotavirus. Rotavirus vaccination can therefore have a significant impact on infant mortality. However, rotavirus vaccine efficacy in Sub-Saharan Africa and Southeast Asia is significantly lower than in high-income countries. Maternally derived antibodies, infant gut microbiota and concomitant oral polio vaccination have been proposed as potential reasons for poor vaccine performance in low-income settings. The overall aim of this study is to compare the role of maternally derived antibodies and infant gut microbiota in determining immune response to rotavirus vaccine in high-income and low-income settings, using the same vaccine and a similar study protocol.Methods and analysisThe study is an observational cohort in three countries—Malawi, India and UK. Mothers will be enrolled in third trimester of pregnancy and followed up, along with infants after delivery, until the infant completes two doses of oral rotavirus vaccine (along with routine immunisation). The levels of prevaccination maternally derived rotavirus-specific antibodies (IgG) will be correlated with infant seroconversion and antibody titres, 4 weeks after the second dose of rotavirus vaccine. Both within-country and between-country comparisons of gut microbiome will be carried out between children who seroconvert and those who do not. The impact of oral polio vaccine coadministration on rotavirus vaccine response will be studied in Indian infants.Ethics and disseminationEthical approvals have been obtained from Integrated Research Application System (IRAS, NHS ethics) in UK, College of Medicine Research and Ethics Committee (COMREC) in Malawi and Institutional Review Board (IRB), Christian Medical College, Vellore in India. Participant recruitment and follow-up is ongoing at all three sites. Analysis of data, followed by publication of the results, is expected in 2018.

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Noninterference of Rotavirus Vaccine With Measles-Rubella Vaccine at 9 Months of Age and Improvements in Antirotavirus Immunity: A Randomized Trial

Cited by 43 publications

References 42 publications

Contribution of Maternal Immunity to Decreased Rotavirus Vaccine Performance in Low- and Middle-Income Countries

Contribution of Maternal Immunity to Decreased Rotavirus Vaccine Performance in Low- and Middle-Income Countries

Estimating the burden of rubella virus infection and congenital rubella syndrome through a rubella immunity assessment among pregnant women in the Democratic Republic of the Congo: Potential impact on vaccination policy

Impact of maternal antibodies and infant gut microbiota on the immunogenicity of rotavirus vaccines in African, Indian and European infants: protocol for a prospective cohort study

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