Safety and Immune Responses After Vaccination with Two Investigational RNA-based Vaccines Against Tuberculosis in BCG Vaccinated Volunteers
Trial status:Recruitment Complete
Trial ID:
BNT164-02
NCT ID:
EudraCT ID:
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
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).
Medical Condition
Trial Drug
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Phase
Phase 1/Phase 2
Type
Interventional
Estimated Enrolment
732
Estimated Trial Date
Jul 2023 - Jun 2026
Trial Participant Requirements
Age
18+ years
Sex
Female & Male
Healthy Volunteers
Yes
Trial Locations
Location
Status
Location
Centro de Investigação em Saúde de Manhiça (CISM)
Manhiça, Mozambique, 1929
Status
Location
Centro de Investigação e Treino em Saúde da Polana Caniço (CISPOC)
Maputo, Mozambique, 1102
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