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Systems Biology to Identify Biomarkers of Neonatal Vaccine Immunogenicity (EPIC-HIPC)

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ClinicalTrials.gov Identifier: NCT03246230
Recruitment Status : Recruiting
First Posted : August 11, 2017
Last Update Posted : January 27, 2020
Sponsor:
Collaborators:
Medical Research Council Unit, The Gambia
University of British Columbia
Institute for Medical Research, Papua New Guinea
The University of Western Australia
Information provided by (Responsible Party):
Ofer Levy, Boston Children’s Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Newborn Vaccine Immunogenicity Biological: Hepatitis B vaccine (HBV) Biological: Bacillus Calmette-Guérin (BCG) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 890 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Newborn infants will have delayed immunization, with catch-up immunization at day of life 7 (DOL7), or immunization at birth with hepatitis B vaccine (HBV), Bacille Calmette-Guérin (BCG) or (HBV +BCG). All participants will have peripheral blood collected at birth (DOL0) and each group will be divided into sub-groups with follow-up peripheral blood collection at DOL1, DOL3, or DOL7.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Systems Biology to Identify Biomarkers of Neonatal Vaccine Immunogenicity
Actual Study Start Date : September 6, 2017
Estimated Primary Completion Date : December 20, 2020
Estimated Study Completion Date : August 20, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: NO VACCINES AT BIRTH
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.
HBV VACCINE AT BIRTH
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.
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.

BCG VACCINE AT BIRTH
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.
Biological: Bacillus Calmette-Guérin (BCG)
Licensed BCG vaccine will be administered at birth (Day of Life 0) or delayed to Day of Life 7.

(HBV + BCG) VACCINES AT BIRTH
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.
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.




Primary Outcome Measures :
  1. Molecular signature correlating with anti-hepatitis B vaccine antibody response [ Time Frame: 1 month of age ]
    We will employ bioinformatics to define molecular signatures correlating with anti-HBV responses



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Ages Eligible for Study:   up to 1 Day   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • <24 hours of age
  • >37 weeks gestational age
  • HIV unexposed
  • Healthy (no malformations, normal temperature range and vital signs for age)

Exclusion Criteria:

  • Premature (<37 weeks gestational age)
  • Hepatitis B antigen-positive mother
  • HIV-positive or HIV-exposed
  • Febrile, unstable vital signs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03246230


Contacts
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Contact: Kerry McEnaney, BS 617-919-2934 kerry.mcenaney@childrens.harvard.edu

Locations
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Gambia
Medical Research Council Unit, The Gambia Recruiting
Fajara, Gambia, 000273
Contact: Beate Kampmann, MD PhD FRCPCH    +220 4494491    bkampmann@mrc.gm   
Contact: Olubukola Idoko, MD MSc FWACP    +220 4495442-6 ext 3031    oidoko@mrc.gm   
Papua New Guinea
Institute for Medical Research Recruiting
Goroka, Eastern Highlands, Papua New Guinea
Contact: Rebecca Ford, PhD       rebecca.ford@pngimr.org.pg   
Contact: William Pomat, PhD       william.pomat@pngimr.org.pg   
Sponsors and Collaborators
Boston Children’s Hospital
Medical Research Council Unit, The Gambia
University of British Columbia
Institute for Medical Research, Papua New Guinea
The University of Western Australia
Investigators
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Principal Investigator: Ofer Levy, MD, PhD Boston Children’s Hospital
Study Director: Tobias R Kollmann, MD, PhD The University of Western Australia
Study Chair: Beate Kampmann, MD, PhD Medical Research Council (MRC) Gambia

Additional Information:
Publications:
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Responsible Party: Ofer Levy, Staff Physician, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT03246230    
Other Study ID Numbers: IRB-P00024239
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ofer Levy, Boston Children’s Hospital:
newborn vaccine responses
Additional relevant MeSH terms:
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Vaccines
BCG Vaccine
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic