BNT164‑02

Durada

2024 - 2029

Coordinador

Clara Suñer

Finançadors

BioNTech

ISGlobal’s partners are supporting a first-of-its-kind clinical trial testing two RNA-based vaccine candidates, BNT164a1 and BNT164b1, aimed at preventing tuberculosis (TB). This Phase Ib/IIa study focuses on safety, tolerability, and immune responses in adults who have previously received BCG vaccination. The trial is randomized, placebo-controlled, and carefully designed to find the optimal dose while evaluating early signs of immune protection.

The study is conducted in two parts. In Part A, participants are assigned to multiple dose groups to identify doses that are well tolerated and generate a strong immune response. Part B extends the evaluation of the most promising doses to a larger, more diverse population, ensuring the vaccine is safe in real-world settings.

Professor Alberto García-Basteiro is site principal investigator for Part B of the trial. He is joined by Dr. Clara Suñer as project coordinator, Dr. Lucía Carratalá as medical investigator, and CISM’s dedicated, multidisciplinary TB research team.

This landmark study marks one of the very first global efforts to bring mRNA technology to tuberculosis prevention—a thrilling and critical step forward towards a new generation of TB vaccines. Read more here: https://clinicaltrials.gov/study/NCT05547464?term=BNT164&rank=2