Clinical trialNCT03897946CompletedPhase 4Interventional

Evaluating Immunogenicity of a Birth Dose of HBV Vaccine in the DRC

SponsorUniversity of North Carolina, Chapel HillEnrollment569Hepatitis B

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This project will assess the immunogenicity of a birth dose of hepatitis B vaccine in hepatitis B-exposed and hepatitis B-unexposed infants in Kinshasa, Democratic Republic of the Congo. A better understanding of the protection offered by the addition of birth dose vaccine to the EPI schedule is necessary in order to promote universal adoption of a birth dose vaccine in the DRC and throughout SSA.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Peyton J Thompson, MD
UNC-Chapel Hill
Principal Investigator
clinicaltrials.gov ↗
Steven R Meshnick, MD, PhD
UNC-Chapel Hill
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Democratic Republic of the Congo

Binza and Kingasani Maternity Centers
Kinshasa, Democratic Republic of the Congo

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Birth dose hepatitis B vaccine

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 20 Aug 2019
Primary completion: 5 Feb 2021
Completion: 5 Feb 2021
Last update posted: 3 Mar 2021
Registered enrollment: 569
Registry id: NCT03897946

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.