# The impact of a Hepatitis B birth dose vaccine on HBV immunogenicity and incidence in children in the DRC

> **NIH NIH F30** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2021 · $38,463

## Abstract

PROJECT SUMMARY
Over the past few decades, viral hepatitis has become a leading cause of death globally, causing more deaths
each year than malaria, HIV/AIDS, or tuberculosis. When considering Hepatitis B (HBV), this large burden of
disease is largely driven by childhood infections, as 90% of infants infected with HBV will develop chronic
hepatitis with lifelong sequelae. Childhood HBV infection occurs through vertical transmission (from mothers to
children during childbirth) and through horizontal transmission (between members of the same household or
community). In sub-Saharan Africa (SSA), where HBV remains endemic, children are vaccinated against HBV
at 6, 10, and 14 weeks of age. This schedule does not protect against vertical transmission, and an estimated
1% of newborns (367,250 infants) in SSA continue to be infected with HBV at birth each year. Administration of
the monovalent HBV vaccine at birth has been shown to have up to 95% protective efficacy against vertical
transmission in the WHO Western Pacific region. However, few studies have been conducted to
characterize the potential impact of providing a birth dose of HBV vaccine in sub-Saharan African
settings. Our partners for this project, the Ministry of Health in the Democratic Republic of the Congo (DRC)
are particularly interested in understanding whether to adopt a national HBV birth dose intervention.
This translational study will provide estimates of the effectiveness and impact of a 4-dose HBV vaccine series
(including a birth dose) in the DRC. The proposed research will utilize previously collected data and dried blood
spots from two trials in Kinshasa Province, DRC: the Birth Dose Immunogenicity Study and the Continuous
Quality Improvement Study. Using advanced epidemiological methods and mathematical modeling, this
proposal aims to 1) compare the proportion of infants who achieve protective immunity to HBV at 12
months of age by vaccine dose series and mothers' HBV and HIV status and 2) model the impact of
adopting a national 4-dose HBV vaccine series, including the birth dose, on the incidence of HBV in
children under 5 in the DRC. The results will provide valuable estimates of the immunogenicity and potential
impact of an HBV birth dose that will inform vaccine policy in the DRC and greater sub-Saharan African region.
Through the completion of these research aims, the trainee will gain a unique set of skills in advanced
epidemiologic methods, mathematical modeling, and vaccine intervention research. Expert mentors in
vaccinology, immunology, modeling, and epidemiology will support the trainee's successful completion of the
proposed research, associated training plan, and MD/PhD degree at the University of North Carolina at Chapel
Hill. This F30 fellowship will aid the applicant's development as a future interdisciplinary physician-scientist
practicing at the intersection of infectious disease, infant health, and interventional epidemiology.

## Key facts

- **NIH application ID:** 10312874
- **Project number:** 1F30AI164818-01
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** Samantha Tulenko
- **Activity code:** F30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $38,463
- **Award type:** 1
- **Project period:** 2021-08-01 → 2026-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10312874

## Citation

> US National Institutes of Health, RePORTER application 10312874, The impact of a Hepatitis B birth dose vaccine on HBV immunogenicity and incidence in children in the DRC (1F30AI164818-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10312874. Licensed CC0.

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