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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
Clinical protocol for a longitudinal cohort study employing systems biology to identify markers of vaccine immunogenicity in newborn infants in the gambia and papua New Guinea
Frontiers in Pediatrics, Volume 8, Article 197, Year 2020
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Description
Background: Infection contributes to significant morbidity and mortality particularly in the very young and in low- and middle-income countries. While vaccines are a highly cost-effective tool against infectious disease little is known regarding the cellular and molecular pathways by which vaccines induce protection at an early age. Immunity is distinct in early life and greater precision is required in our understanding of mechanisms of early life protection to inform development of new pediatric vaccines. Methods and Analysis: We will apply transcriptomic, proteomic, metabolomic, multiplex cytokine/chemokine, adenosine deaminase, and flow cytometry immune cell phenotyping to delineate early cellular and molecular signatures that correspond to vaccine immunogenicity. This approach will be applied to a neonatal cohort in The Gambia (N ∼ 720) receiving at birth: (1) Hepatitis B (HepB) vaccine alone, (2) Bacille Calmette Guerin (BCG) vaccine alone, or (3) HepB and BCG vaccines, (4) HepB andBCG vaccines delayed till day 10 at the latest. Each study participant will have a baseline peripheral blood sample drawn at DOL0 and a second blood sample at DOL1,−3, or−7 as well as late timepoints to assess HepB vaccine immunogenicity. Blood will be fractionated via a “small sample big data” standard operating procedure that enables multiple downstream systems biology assays. We will apply both univariate and multivariate frameworks and multi-OMIC data integration to identify features associated with anti-Hepatitis B (anti-HB) titer, an established correlate of protection. Cord blood sample collection from a subset of participants will enable human in vitro modeling to test mechanistic hypotheses identified in silico regarding vaccine action. Maternal anti- HB titer and the infant microbiome will also be correlated with our findings which will be validated in a smaller cohort in Papua New Guinea (N ∼ 80). Ethics and Dissemination: The study has been approved by The Gambia Government/MRCG Joint Ethics Committee and The Boston Children’s Hospital Institutional Review Board. Ethics review is ongoing with the Papua New Guinea Medical Research Advisory Committee. All de-identified data will be uploaded to public repositories following submission of study output for publication. Feedback meetings will be organized to disseminate output to the study communities. Clinical Trial Registration: Clinicaltrials.gov Registration Number: NCT03246230. © 2020 Idoko, Smolen, Wariri.
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC7205022/bin/Data_Sheet_1.docx
Authors & Co-Authors
Idoko, Olubukola T.
United Kingdom, London
London School of Hygiene & Tropical Medicine
United States, Boston
Boston Children's Hospital
Germany, Munich
Ludwig-maximilians-universität München
Smolen, K. K.
United States, Boston
Boston Children's Hospital
United States, Boston
Harvard Medical School
Wariri, Oghenebrume
United Kingdom, London
London School of Hygiene & Tropical Medicine
Imam, Abdulazeez
United Kingdom, London
London School of Hygiene & Tropical Medicine
Shannon, Casey P.
Canada, Vancouver
Proof Centre of Excellence
Diray-Arce, Joann
United States, Boston
Boston Children's Hospital
United States, Boston
Harvard Medical School
Darboe, Alansana
United Kingdom, London
London School of Hygiene & Tropical Medicine
Ben-Othman, Rym
Canada, Vancouver
Bc Children's Hospital
Odumade, Oludare A.
United States, Boston
Boston Children's Hospital
United Kingdom, London
London School of Hygiene & Tropical Medicine
United States, Boston
Harvard Medical School
McEnaney, Kerry
United States, Boston
Boston Children's Hospital
Amenyogbe, Nelly A.
Australia, Perth
The University of Western Australia
Pomat, William S.
Papua new Guinea, Goroka
Papua new Guinea Institute of Medical Research
Van Haren, Simon Daniël
United States, Boston
Boston Children's Hospital
United States, Boston
Harvard Medical School
Sánchez-Schmitz, Guzmán
United States, Boston
Boston Children's Hospital
United States, Boston
Harvard Medical School
Brinkman, Ryan R.
Canada, Vancouver
British Columbia Cancer Agency
Canada, Vancouver
The University of British Columbia
Steen, Hanno
United States, Boston
Boston Children's Hospital
United States, Boston
Harvard Medical School
Hancock, Robert E.W.
Canada, Vancouver
The University of British Columbia
Tebbutt, Scott J.
Canada, Vancouver
Proof Centre of Excellence
Canada, Vancouver
Centre for Heart Lung Innovation
Canada, Vancouver
The University of British Columbia
Richmond, Peter
Australia, Perth
The University of Western Australia
Australia, Perth
Uwa Medical School
van den Biggelaar, Anita Huiberdina Johanna
Australia, Perth
The University of Western Australia
Kollmann, Tobias R.
Australia, Perth
The University of Western Australia
Levy, Ofer
United States, Boston
Boston Children's Hospital
United States, Boston
Harvard Medical School
United States, Cambridge
Massachusetts Institute of Technology
Ozonoff, Al
United States, Boston
Boston Children's Hospital
United States, Boston
Harvard Medical School
Kampmann, Beate B.
United Kingdom, London
London School of Hygiene & Tropical Medicine
Statistics
Citations: 10
Authors: 24
Affiliations: 13
Identifiers
Doi:
10.3389/fped.2020.00197
ISSN:
22962360
Research Areas
Health System And Policy
Infectious Diseases
Maternal And Child Health
Study Design
Cohort Study
Study Approach
Quantitative
Study Locations
Gambia
Guinea