NCT03246230: EPIC-HIPC

Systems Biology to Identify Biomarkers of Neonatal Vaccine Immunogenicity

Completed NA Last updated 6 December 2023

What this trial tests

NA trial testing Hepatitis B vaccine (HBV) in Newborn Vaccine Immunogenicity in 911 participants. Completed in 29 August 2022.

Timeline

6 September 2017

Primary endpoint
29 August 2022

29 August 2022

Quick facts

Lead sponsor	Boston Children's Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	911
Start date	6 September 2017
Primary completion	29 August 2022
Estimated completion	29 August 2022
Sites	2 locations across The Gambia, Papua New Guinea

Drugs / interventions tested

• Hepatitis B vaccine (HBV) — full drug profile →
• Bacillus Calmette-Guérin (BCG) — full drug profile →

Conditions studied

• Newborn Vaccine Immunogenicity — all drugs for Newborn Vaccine Immunogenicity →

Sponsor

Boston Children's Hospital

Who can join

Adults 0 Days to 1 Day, any sex, with Newborn Vaccine Immunogenicity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. BCG vaccination-induced emergency granulopoiesis provides rapid protection from neonatal sepsis.
   Brook B, Harbeson DJ, Shannon CP, Cai B, et al · · 2020 · cited 99× · PMID 32376769 · DOI 10.1126/scitranslmed.aax4517
2. 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.
   Idoko OT, Smolen KK, Wariri O, Imam A, et al · · 2020 · cited 19× · PMID 32426309 · DOI 10.3389/fped.2020.00197
3. Ontogeny of plasma cytokine and chemokine concentrations across the first week of human life.
   Smolen KK, Plotkin AL, Shannon CP, Idoko OT, et al · · 2021 · cited 10× · PMID 34597920 · DOI 10.1016/j.cyto.2021.155704
4. DNA Methylation signatures underpinning blood neutrophil to lymphocyte ratio during first week of human life.
   Martino D, Kresoje N, Amenyogbe N, Ben-Othman R, et al · · 2024 · cited 9× · PMID 39289350 · DOI 10.1038/s41467-024-52283-9
5. Plasma Adenosine Deaminase (ADA)-1 and -2 Demonstrate Robust Ontogeny Across the First Four Months of Human Life.
   Odumade OA, Plotkin AL, Pak J, Idoko OT, et al · · 2021 · cited 8× · PMID 34122398 · DOI 10.3389/fimmu.2021.578700
6. Predictive gene expression signature diagnoses neonatal sepsis before clinical presentation.
   An AY, Acton E, Idoko OT, Shannon CP, et al · · 2024 · cited 6× · PMID 39472236 · DOI 10.1016/j.ebiom.2024.105411
7. A single birth dose of Hepatitis B vaccine induces polyfunctional CD4⁺ T helper cells.
   Strandmark J, Darboe A, Diray-Arce J, Ben-Othman R, et al · · 2022 · cited 4× · PMID 36426360 · DOI 10.3389/fimmu.2022.1043375
8. Breastfeeding and Neonatal Age Influence Neutrophil-Driven Ontogeny of Blood Cell Populations in the First Week of Human Life.
   Montante S, Ben-Othman R, Amenyogbe N, Angelidou A, et al · · 2024 · cited 3× · PMID 39081632 · DOI 10.1155/2024/1117796