10.3389/fped.2020.00197.s001
Olubukola T. Idoko
Olubukola T.
Idoko
Kinga K. Smolen
Kinga K.
Smolen
Oghenebrume Wariri
Oghenebrume
Wariri
Abdulazeez Imam
Abdulazeez
Imam
Casey P. Shannon
Casey P.
Shannon
Tida Dibassey
Tida
Dibassey
Joann Diray-Arce
Joann
Diray-Arce
Alansana Darboe
Alansana
Darboe
Julia Strandmark
Julia
Strandmark
Rym Ben-Othman
Rym
Ben-Othman
Oludare A. Odumade
Oludare A.
Odumade
Kerry McEnaney
Kerry
McEnaney
Nelly Amenyogbe
Nelly
Amenyogbe
William S. Pomat
William S.
Pomat
Simon van Haren
Simon
van Haren
Guzmán Sanchez-Schmitz
Guzmán
Sanchez-Schmitz
Ryan R. Brinkman
Ryan R.
Brinkman
Hanno Steen
Hanno
Steen
Robert E. W. Hancock
Robert E. W.
Hancock
Scott J. Tebbutt
Scott J.
Tebbutt
Peter C. Richmond
Peter C.
Richmond
Anita H. J. van den Biggelaar
Anita H. J.
van den Biggelaar
Tobias R. Kollmann
Tobias R.
Kollmann
Ofer Levy
Ofer
Levy
Al Ozonoff
Al
Ozonoff
Beate Kampmann
Beate
Kampmann
Data_Sheet_1_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.docx
Frontiers
2020
markers
newborn
vaccine
immunogenicity
systems biology
OMICS
2020-04-30 16:11:16
Dataset
https://frontiersin.figshare.com/articles/dataset/Data_Sheet_1_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_docx/12221771
<p>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.</p><p>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 and BCG 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).</p><p>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.</p><p>Clinical Trial Registration: Clinicaltrials.gov Registration Number: NCT03246230</p>