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ACTIVE NOT RECRUITING
NCT05547464
PHASE1/PHASE2

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

Sponsor: BioNTech SE

View on ClinicalTrials.gov

Summary

This is a two-part randomized, placebo-controlled, observer-blind, safety and dose-finding Phase Ib/IIa study. This study will evaluate up to four dose levels of the BNT164 investigational vaccines (BNT164a1 and BNT164b1) to select a safe and tolerable dose in a three-dose schedule. This study includes: Part A (Phase Ib) and Part B (Phase IIa).

Official title: A Phase Ib/IIa Two-part, Randomized, Placebo-controlled, Observer-blind, Dose-finding Evaluation Trial to Describe the Safety, Reactogenicity, and Immunogenicity of Two Investigational Vaccines Against Tuberculosis in BCG Vaccinated, HIV-negative Subjects

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

497

Start Date

2023-07-31

Completion Date

2027-01

Last Updated

2026-03-18

Healthy Volunteers

Yes

Conditions

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

Locations (8)

Centro de Investigação em Saúde de Manhiça (CISM) (recruiting participants for Part B only)

Manhiça, Mozambique

Centro de Investigação e Treino em Saúde da Polana Caniço (CISPOC) (recruiting participants for Part B only)

Maputo, Mozambique

CAPRISA eThekweni Clinical Research Site

Berea, South Africa

South African Tuberculosis Vaccine Initiative SATVI

Cape Town, South Africa

Centre for Lung Infection and Immunity UCT Lung Institute

Cape Town, South Africa

Desmond Tutu Health Foundation - Masiphumele Research Office

Cape Town, South Africa

Africa Health Research Institute (AHRI)

Mtubatuba, South Africa

The Aurum Institute Tembisa CRC Clinic 4

Tembisa, South Africa