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

NCT03897946 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 569

Last updated 2021-03-03

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

Birth dose hepatitis B vaccine

Groups A and C will receive a birth dose of hepatitis B vaccine within 24 hours of life.

Sponsors & Collaborators

  • The American Society of Tropical Medicine and Hygiene

    collaborator OTHER

  • Burroughs Wellcome

    collaborator INDUSTRY

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Steven R Meshnick, MD, PhD · UNC-Chapel Hill

  • Peyton J Thompson, MD · UNC-Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-20
Primary Completion
2021-02-05
Completion
2021-02-05

Countries

  • Democratic Republic of the Congo

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03897946 on ClinicalTrials.gov