MedTrace Logo

BCG Revaccination With the Third Dose of Diphtheria-tetanus-pertussis Vaccine and Infant Mortality in Africa

NCT07005726 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6000

Last updated 2025-06-12

No results posted yet for this study

Summary

Studies in low-income countries show that vaccines can have important non-specific effects on other infections. Live BCG vaccine can train the immune system and reduce susceptibility to unrelated infections. In contrast, non-live diphtheria-tetanus-pertussis-containing (DTP) vaccine enhances susceptibility in females: DTP vs no DTP is associated with 2-fold higher mortality, and in DTP-vaccinated children, females have higher mortality than males. These effects are seen as long as a vaccine is the most recent vaccine. WHO recommends BCG at birth followed by three DTP vaccines. A metaanalysis based on observational studies has shown that co-administration of BCG+DTP is associated with lower mortality than BCG followed by DTP.

The investigators will implement a randomised trial in urban Guinea-Bissau, including 6000 children, to test the hypothesis that an extra dose of BCG given with DTP3 (BCG2+DTP3 vs. DTP3) can:

* reduce death and hospital admissions by 25%
* reduce the F/M severe morbidity hazard ratio

Conditions

  • Infant Morbidity
  • Infant Mortality
  • Non-Specific Effects of Vaccines
  • BCG

Interventions

BIOLOGICAL

BCG Vaccine

The WHO-prequalified BCG-Japan or BCG-Denmark

Sponsors & Collaborators

  • University of Southern Denmark

    collaborator OTHER

  • Radboud University Medical Center

    collaborator OTHER

  • Bandim Health Project

    lead OTHER

Principal Investigators

  • Christine Stabell Benn, MD, PhD, DMSc · Bandim Health Project and Danish Institute for Advanced Science, University of Southern Denmark

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
14 Weeks
Max Age
24 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-09
Primary Completion
2030-05-31
Completion
2030-07-31

Countries

  • Guinea-Bissau

Study Locations

More Related Trials

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 NCT07005726 on ClinicalTrials.gov