Abstract
The WHO recommends hepatitis B birth-dose vaccination (HepB-BD), but it is not routinely given in most sub-Saharan African countries. We aimed to assess the immunogenicity of HepB-BD in addition to the existing hepatitis B vaccine (HepB3) schedule in Kinshasa, Democratic Republic of Congo among HBV-unexposed and HBV-exposed infants. Using an open-label, randomised, controlled design, HBV-unexposed infants were randomised (1:1) to receive the standard HepB3 vaccine series (group U3), or to receive HepB-BD in addition to HepB3 (group U4). A supplemental cohort of HBV-exposed infants (group E4) received HepB-BD and HepB3. We compared the proportion of infants with protective antibodies against HBV (HBV surface antibody ≥ 10 mIU/mL) between groups U3 and U4 and groups U4 and E4 at 12 months of age. Between August 20 and October 9, 2019, we enrolled 281 mother/infant dyads; 88 (31.3%) returned at 12 months. Most infants had protective antibodies against HBV at 12 months: 92.9% (75.7%–98.2%) in group U3, 85.7% (67.5%–94.5%) in group U4 and 96.9% (95% CI: 81.2%–99.6%) in group E4. Trends held in estimates adjusted for loss-to-follow-up (LTFU) and baseline imbalance across groups. In this first randomised trial assessing the addition of HepB-BD to the hepatitis B vaccine schedule in SSA, we found that HBV-unexposed infants who received the 3-dose and 4-dose vaccine series had similar immunogenicity against HBV at 12 months. A high proportion of infants, and notably HBV-exposed infants, had protective antibodies. Though extrapolation of findings may be limited by LTFU, this study adds real-world evidence regarding HepB-BD implementation in sub-Saharan Africa. Trial Registration: ClinicalTrials.gov identifier: NCT03897946.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 795-807 |
| Number of pages | 13 |
| Journal | Journal of Viral Hepatitis |
| Volume | 31 |
| Issue number | 12 |
| DOIs | |
| State | Published - Dec 2024 |
Funding
The HBV\u2010BDI study was funded by a postdoctoral fellowship in tropical medicine from ASTMH/Burroughs\u2010Wellcome Fund granted to P.T. The preceding AVERT\u2010HBV study was funded by the Gillings Innovation Laboratory award\u2014funded by the 2007 Gillings Gift to the University of North Carolina\u2013Chapel Hill's Gillings School of Global Public Health. The HIV prevention of mother\u2010to\u2010child transmission study whose infrastructure was leveraged for this project was supported by NIH grants (NICHD R01HD087993, NICHD R01HD105526, and NIAID U01AI096299; PI Yotebieng). S.E.T. is funded by an NIH pre\u2010doctoral training grant (F30AI164818). S.B.\u2010D. received salary support from an NIH grant (NIAID K24AI141744). P.T. received salary support from an NIH grant (NIAID K08AI148607). The content is solely the authors' responsibility and does not necessarily represent the official views of the National Institutes of Health. We are grateful to all of the women and infants who participated in this study, the staff at the Binza and Kingasani maternity clinics, and provincial and national health authorities in Kinshasa and DRC. We would like to thank Dr. Noro Ravelomanana, Dr. Malongo Fathy and Dr. Bienvenu Kawende for their contributions to this study. We also acknowledge the support of administrative staff at the Kinshasa School of Public Health and at the University of North Carolina. We grieve the loss of Dr. Steven Meshnick, whose vision and mentorship were critical to the success of this study. Funding: This work was supported by the National Institute of Allergy and Infectious Diseases, National Institute of Child Health and Human Development, UNC Gillings School of Public Health, Burroughs Wellcome Fund and American Society of Tropical Medicine and Hygiene The HBV-BDI study was funded by a postdoctoral fellowship in tropical medicine from ASTMH/Burroughs-Wellcome Fund granted to P.T. The preceding AVERT-HBV study was funded by the Gillings Innovation Laboratory award\u2014funded by the 2007 Gillings Gift to the University of North Carolina\u2013Chapel Hill's Gillings School of Global Public Health. The HIV prevention of mother-to-child transmission study whose infrastructure was leveraged for this project was supported by NIH grants (NICHD R01HD087993, NICHD R01HD105526, and NIAID U01AI096299; PI Yotebieng). S.E.T. is funded by an NIH pre-doctoral training grant (F30AI164818). S.B.-D. received salary support from an NIH grant (NIAID K24AI141744). P.T. received salary support from an NIH grant (NIAID K08AI148607). The content is solely the authors' responsibility and does not necessarily represent the official views of the National Institutes of Health. We are grateful to all of the women and infants who participated in this study, the staff at the Binza and Kingasani maternity clinics, and provincial and national health authorities in Kinshasa and DRC. We would like to thank Dr. Noro Ravelomanana, Dr. Malongo Fathy and Dr. Bienvenu Kawende for their contributions to this study. We also acknowledge the support of administrative staff at the Kinshasa School of Public Health and at the University of North Carolina. We grieve the loss of Dr. Steven Meshnick, whose vision and mentorship were critical to the success of this study. Outside of the submitted work, J.B.P. and P.T. report research support from Gilead Sciences and non\u2010financial support from Abbott Diagnostics; R.J. reports research support from Saol Therapeutics and GSK. R.J. receives consulting fees from AstraZeneca, Seqirus and Dynavax; payment for expert testimony from Quinn Johnson (Peoria, IL); and editorial stipends from Elsevier and the Paediatric Infectious Diseases Society. J.B.P. also receives research support from the World Health Organization and the Bill and Melinda Gates Foundation, consulting fees from Zymeron Corp and an honorarium from Virology Education.
Keywords
- Democratic Republic of the Congo
- hepatitis B vaccines
- hepatitis B virus
- infectious disease transmission
ASJC Scopus subject areas
- Hepatology
- Infectious Diseases
- Virology
