NCT03246230|Completed
Systems Biology to Identify Biomarkers of Neonatal Vaccine Immunogenicity
EPIC-HIPC
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EPIC-HIPC
Sponsor study identifier
interventional
911
2 countries
2
Study Start
September 6, 2017
Actual (reported)Primary Completion
August 29, 2022
Actual (reported)Study Completion
August 29, 2022
Actual (reported)Infection is the most common cause of death in early life, especially for newborns and can be reduced by immunization but insufficient knowledge of how vaccines protect the very young limits their optimal use. To gain insight into how vaccines induce protection of the most vulnerable, this National Institutes of Health (NIH)/National Institute of Allergy \& Infectious Diseases (NIAID)-funded Human Immunology Project Consortium (HIPC) study, based at Boston Children's Hospital and conducted by the Expanded Program on Immunization Consortium (EPIC), employs two novel approaches studying newborn responses to hepatitis B vaccine (HBV): (a) systems biology that uses technologies which comprehensively measure global changes in molecules such as transcriptomics (RNA) and proteomics (proteins), as well as cell composition of the blood and (b) use of human newborn blood components, collected prior to immunization, to model vaccine responses in vitro (outside the body). Characterizing vaccine-induced molecular patterns ("signatures") that correspond to vaccine-mediated protection will accelerate development and optimization of vaccines against early life infections of major global health importance.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 29, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 4, 2017
Actual (reported)August 11, 2017
Actual (reported)September 6, 2017
Actual (reported)August 29, 2022
Actual (reported)August 29, 2022
Actual (reported)Molecular signature correlating with anti-hepatitis B vaccine antibody response
We will employ bioinformatics to define molecular signatures correlating with anti-HBV responses
1 month of age
These will be newborns who will not receive any vaccines at birth and will have delayed immunization with catch-up (i.e., HBV, BCG and polio vaccine) by Day of Life 7.
Participants in this arm will receive licensed hepatitis B vaccine (HBV) at birth (Day of Life (DOL)-0) with catch up immunization (i.e., BCG and polio vaccine) at DOL-1, -3, or -7.
Participants in this arm will receive licensed Bacillus Calmette-Guérin (BCG) vaccine at birth (Day of Life(DOL)-0) with catch up immunization (i.e., HBV and polio vaccine) at DOL-1, -3 or- 7.
Licensed pediatric HBV vaccine will be administered at birth (Day of Life 0) or delayed to Day of Life 7.
Licensed BCG vaccine will be administered at birth (Day of Life 0) or delayed to Day of Life 7.
Institute for Medical Research
Goroka, Eastern Highlands Province, Papua New Guinea
Medical Research Council Unit, The Gambia
Fajara, 000273, The Gambia
Amenyogbe N, Levy O, Kollmann TR. Systems vaccinology: a promise for the young and the poor. Philos Trans R Soc Lond B Biol Sci. 2015 Jun 19;370(1671):20140340. doi: 10.1098/rstb.2014.0340.
Lee AH, Shannon CP, Amenyogbe N, Bennike TB, Diray-Arce J, Idoko OT, Gill EE, Ben-Othman R, Pomat WS, van Haren SD, Cao KL, Cox M, Darboe A, Falsafi R, Ferrari D, Harbeson DJ, He D, Bing C, Hinshaw SJ, Ndure J, Njie-Jobe J, Pettengill MA, Richmond PC, Ford R, Saleu G, Masiria G, Matlam JP, Kirarock W, Roberts E, Malek M, Sanchez-Schmitz G, Singh A, Angelidou A, Smolen KK; EPIC Consortium; Brinkman RR, Ozonoff A, Hancock REW, van den Biggelaar AHJ, Steen H, Tebbutt SJ, Kampmann B, Levy O, Kollmann TR. Dynamic molecular changes during the first week of human life follow a robust developmental trajectory. Nat Commun. 2019 Mar 12;10(1):1092. doi: 10.1038/s41467-019-08794-x.
Ofer Levy, MD, PhD
Boston Children's Hospital
Tobias R Kollmann, MD, PhD
The University of Western Australia
Beate Kampmann, MD, PhD
Medical Research Council (MRC) Gambia
911 participants (actual enrollment reported by the registry).
First Submitted
August 4, 2017
First Posted
August 11, 2017
Participants in this arm will receive licensed hepatitis B vaccine (HBV) and licensed Bacillus Calmette-Guérin (BCG) vaccine at birth (Day of Life (DOL- 0) with catch up immunization (i.e., polio vaccine) at DOL-1, -3, or -7.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Checkervarty AK, Shannon CP, Blimkie TM, Dhillon BK, Falsafi R, Angelidou A, Diray-Arce J, Bennike TB, Archer NM, Idoko OT, McEnaney K, Ozonoff A, Odumade OA, Ben-Othman R, Smolen KK, Steen H; EPIC-HIPC Consortium; Kampmann B, Kollmann TR, Levy O, Lee AH, Hancock REW, Tebbutt SJ. Newborns with sickle cell trait have distinct peripheral blood molecular signatures across the first week of life. Blood Red Cells Iron. 2026 Jun;2(2):100051. doi: 10.1016/j.brci.2026.100051. Epub 2026 Mar 31.
Dhillon BK, Blimkie TM, Idoko OT, Ford R, Angelidou A, Ben-Othman R, Montante S, Amenyogbe N, Dibassey T, Diray-Arce J, Falsafi R, Imam A, McEnaney K, Odumade OA, Ozonoff A, Pomat WS, Richmond PC, Smolen KK, Wariri O; EPIC-HIPC Consortium; Levy O, van den Biggelaar AHJ, Kampmann B, Kollmann TR, Lee AHY, Hancock REW. Population-specific heterogeneity in ontogeny of the broadly-conserved blood transcriptional program during the first week of life. Nat Commun. 2026 Jun 1;17(1):5673. doi: 10.1038/s41467-026-73244-4.
Diray-Arce J, Syphurs C, Hoch A, McEnaney K, Smolen KK, Wariri O, Imam A, Dibassey T, Cole F, Ceesay F, Darboe A, Pomat WS, Ford R, Masiria G, Joseph D, Jude J, Ben-Othman R, Shannon CP, Thomas S, Leroux-Roels G, Clement F, Waerlop G, McLoughlin C, Vignolo SM, Rao S, Amenyogbe N; EPIC Consortium; Odumade O, Angelidou A, Tebbutt SJ, Marchant A, Kollmann TR, Levy O, Richmond PC, van den Biggelaar AHJ, Kampmann B, Idoko OT, Ozonoff A. A randomized prospective study of neonatal hepatitis B vaccine immunogenicity in The Gambia and Papua New Guinea. J Allergy Clin Immunol Glob. 2026 Feb 6;5(3):100653. doi: 10.1016/j.jacig.2026.100653. eCollection 2026 May.
Montante S, Ben-Othman R, Amenyogbe N, Angelidou A, van den Biggelaar A, Cai B, Chen Y, Darboe A, Diray-Arce J, Ford R, Idoko O, Lee A, Lo M, McEnaney K, Malek M, Martino D, Masiria G, Odumade OA, Pomat W, Shannon C, Smolen K, Consortium TE, Ozonoff A, Richmond P, Tebbutt S, Levy O, Kampmann B, Brinkman R, Kollmann T. Breastfeeding and Neonatal Age Influence Neutrophil-Driven Ontogeny of Blood Cell Populations in the First Week of Human Life. J Immunol Res. 2024 Jul 23;2024:1117796. doi: 10.1155/2024/1117796. eCollection 2024.
Idoko OT, Smolen KK, Wariri O, Imam A, Shannon CP, Dibassey T, Diray-Arce J, Darboe A, Strandmark J, Ben-Othman R, Odumade OA, McEnaney K, Amenyogbe N, Pomat WS, van Haren S, Sanchez-Schmitz G, Brinkman RR, Steen H, Hancock REW, Tebbutt SJ, Richmond PC, van den Biggelaar AHJ, Kollmann TR, Levy O, Ozonoff A, Kampmann B. 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. Front Pediatr. 2020 Apr 30;8:197. doi: 10.3389/fped.2020.00197. eCollection 2020.
Study Start
September 6, 2017
Actual (reported)Primary Completion
August 29, 2022
Actual (reported)Study Completion
August 29, 2022
Actual (reported)Last Updated
December 6, 2023
Record last verified: 2023-11
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