Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in BCG Vaccinated Volunteers
Trial status:Recruitment Complete
Study Identifier:
BNT164-02
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech SE
Recruitment Complete
Trial details
Medical Condition
Study Drug
Phase
Phase 1
Sex
Female & Male
Age
18 - 55 Years
Estimated Trial Date
Jul 2023 - May 2026
Protocol summary
This two-part randomized, placebo-controlled, observer-blind, safety and dose-finding Phase Ib/IIa study will be conducted in countries in Africa and Asia, including Republic of South Africa, Mozambique, and Republic of the Philippines. 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).
Trial locations
Location
Status
Location
CAPRISA eThekweni Clinical Research Site
Berea, South Africa, 4001
Status
Location
South African Tuberculosis Vaccine Initiative SATVI
Cape Town, South Africa, 6850
Status
Location
Centre for Lung Infection and Immunity UCT Lung Institute
Cape Town, South Africa, 7700
Status
Location
Desmond Tutu Health Foundation - Masiphumele Research Office
Cape Town, South Africa, 7975
Status
Location
Africa Health Research Institute (AHRI)
Mtubatuba, South Africa, 3935
Status
Location
The Aurum Institute Tembisa CRC Clinic 4
Tembisa, South Africa, 1632
Status