Systems Biology to Identify Biomarkers of Neonatal Vaccine Immunogenicity

Summary

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.

Conditions

• Newborn Vaccine Immunogenicity

Interventions

BIOLOGICAL

Hepatitis B vaccine (HBV)

Licensed pediatric HBV vaccine will be administered at birth (Day of Life 0) or delayed to Day of Life 7.

BIOLOGICAL

Bacillus Calmette-Guérin (BCG)

Licensed BCG vaccine will be administered at birth (Day of Life 0) or delayed to Day of Life 7.

Sponsors & Collaborators

• Medical Research Council Unit, The Gambia

  collaborator OTHER

• University of British Columbia

  collaborator OTHER

• Institute for Medical Research, Papua New Guinea

  collaborator UNKNOWN

• The University of Western Australia

  collaborator OTHER

• Boston Children's Hospital

  lead OTHER

Principal Investigators

• 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

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

0 Days

Max Age

1 Day

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-09-06

Primary Completion

2022-08-29

Completion

2022-08-29

Countries

• Papua New Guinea
• The Gambia

Study Locations