Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in BCG Vaccinated Volunteers

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

497

Participants

Timeline

Start Date

July 31, 2023

Primary Completion Date

March 31, 2026

Study Completion Date

December 31, 2026

Conditions
Tuberculosis
Interventions
BIOLOGICAL

BNT164a1

Multi-antigen ribonucleic acid (RNA) vaccine for active immunization against tuberculosis administered as intramuscular injection

BIOLOGICAL

BNT164b1

Multi-antigen RNA vaccine for active immunization against tuberculosis administered as intramuscular injection

OTHER

Placebo

Placebo

Trial Locations (8)

1102

Centro de Investigação e Treino em Saúde da Polana Caniço (CISPOC), Maputo

1632

The Aurum Institute Tembisa CRC Clinic 4, Tembisa

1929

Centro de Investigação em Saúde de Manhiça (CISM), Manhiça

3935

Africa Health Research Institute (AHRI), Mtubatuba

4001

CAPRISA eThekweni Clinical Research Site, Berea

6850

South African Tuberculosis Vaccine Initiative SATVI, Cape Town

7700

Centre for Lung Infection and Immunity UCT Lung Institute, Cape Town

7975

Desmond Tutu Health Foundation - Masiphumele Research Office, Cape Town

Sponsors

Lead Sponsor

All Listed Sponsors
lead

BioNTech SE

INDUSTRY