Evaluating Immunogenicity of a Birth Dose of HBV Vaccine in the DRC
Hepatitis B
About this trial
This is an interventional prevention trial for Hepatitis B
Eligibility Criteria
MOTHERS
Inclusion Criteria
- HBsAg+ mothers and HBsAg- mothers will be recruited from the cohort screened during the AVERT study at 2 maternity centers (Binza and Kingasani) in Kinshasa.
Exclusion Criteria
- Any women who do not intend to stay in Kinshasa for prenatal care through delivery or who deliver at a facility other than Binza or Kingasani
- Women <18 years of age
INFANTS
Inclusion Criteria
- Infants born to HBsAg-positive and HBsAg-negative women who receive care at Binza and Kingasani maternity centers will be recruited for participation in this study.
Exclusion Criteria
- HIV-exposed infants (those born to HIV-positive mothers) will be excluded given an expected difference in immune response in these infants and inability to recruit enough HIV-exposed infants to be able to detect these differences in immune response
- HBV-unexposed infants weighing <2,000 grams at birth will not be eligible to receive the birth HBV vaccine. (HBV-exposed infants receive the birth dose vaccine regardless of birth weight because the potential benefit of preventing mother-to-child transmission outweighs the potential risk of vaccination in a low birthweight infant. The research team recognizes that Group B may include a disproportionate number of low birthweight infants compared to Group C, but will account for this in post-hoc analyses and if need be, will exclude low birthweight infants from the analysis to account for potential bias).
- Infants born at a facility other than one of the two maternity centers
Sites / Locations
- Binza and Kingasani Maternity Centers
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
No Intervention
Experimental
Group A: Hepatitis B exposed, with birth dose
Group B: Hepatitis B unexposed, no birth dose
Group C: Hepatitis B unexposed, with birth dose
The 100 HBV-exposed (born to HBsAg-positive mothers) infants who are already enrolled in the parent AVERT study will also be enrolled in the current study, as the "HBV-exposed cohort" (Group A). These exposed infants will not receive additional interventions on top of the AVERT study since they will already be receiving a birth dose vaccine through the AVERT study.
For the "HBV-unexposed cohort" in this study, the investigators will enroll 200 infants born to HBsAg-negative mothers. Half (100) of these infants will receive the routine three-dose series of HBV vaccine according to the standard EPI schedule in the DRC with no additional birth dose vaccine (Group B).
Group C will consist of the other half (100) of infants in the "HBV-unexposed cohort" who will receive four doses of HBV vaccine including a birth dose vaccine prior to the routine EPI schedule.