drugset / Trial / NCT06670755
ID93/GLA-SE Vaccination + BCG Challenge
Non-randomizedParallel-groupOpen-labelOther
Summary
The purpose of this study is to: 1. Demonstrate the safety of a novel TB vaccine (ID93/GLA-SE) when given to both BCG-vaccinated and BCG-naïve volunteers. 2. Provide preliminary immunogenicity data of this novel TB vaccine (ID93/GLA-SE). This clinical trial will apply an aerosol BCG challenge model involving 48 participants - 24 historically BCG-vaccinated volunteers and 24 BCG-naïve volunteers. Bronchoscopies will be performed 14 days post-challenge to measure BCG recovered from bronchial samples. Blood tests will be taken to look at potential immunological markers of immunity.
Timeline
- Start
- 2024-12-18
- Primary completion
- 2027-07
- Completion
- 2027-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ID93 | Protein / enzyme biologic | — | Intramuscular |