Systems Biology to Identify Biomarkers of Neonatal Vaccine Immunogenicity (EPIC-HIPC)
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ClinicalTrials.gov Identifier: NCT03246230 |
Recruitment Status :
Active, not recruiting
First Posted : August 11, 2017
Last Update Posted : March 21, 2022
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Condition or disease | Intervention/treatment | Phase |
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Newborn Vaccine Immunogenicity | Biological: Hepatitis B vaccine (HBV) Biological: Bacillus Calmette-Guérin (BCG) | Not Applicable |

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 : | June 30, 2022 |
Estimated Study Completion Date : | September 30, 2022 |

Arm | Intervention/treatment |
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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.
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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.
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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.
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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.
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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. |
- 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 |
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

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
Gambia | |
Medical Research Council Unit, The Gambia | |
Fajara, Gambia, 000273 | |
Papua New Guinea | |
Institute for Medical Research | |
Goroka, Eastern Highlands, Papua New Guinea |
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 |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: | March 21, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
newborn vaccine responses |
BCG Vaccine Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |