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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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Title: 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
Authors: Sindhu, KNC
Cunliffe, N
Peak, M
Turner, M
Darby, A
Grassly, N
Gordon, M
Dube, Q
Babji, S
Praharaj, I
Verghese, V
Iturriza-Gomara, M
Kang, G
Item Type: Journal Article
Abstract: Introduction Gastroenteritis 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 analysis The 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 dissemination Ethical 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.
Issue Date: 1-Mar-2017
Date of Acceptance: 28-Feb-2017
URI: http://hdl.handle.net/10044/1/53769
DOI: https://dx.doi.org/10.1136/bmjopen-2017-016577
ISSN: 2044-6055
Publisher: BMJ Journals
Journal / Book Title: BMJ Open
Volume: 7
Issue: 3
Copyright Statement: This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/
Sponsor/Funder: Medical Research Council (MRC)
Funder's Grant Number: JXR11990
Keywords: Science & Technology
Life Sciences & Biomedicine
Medicine, General & Internal
General & Internal Medicine
PLACEBO-CONTROLLED TRIAL
DEVELOPING-COUNTRIES
IMMUNE-RESPONSE
BIRTH COHORT
DOUBLE-BLIND
BREAST-MILK
CHILDREN
MORTALITY
EFFICACY
BURDEN
Publication Status: Published
Article Number: e016577
Appears in Collections:Epidemiology, Public Health and Primary Care



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