drugset / Trial / NCT03912207
Investigating Immune Responses to Aerosol BCG Challenge in Healthy UK Adults
Phase 1
Unknown
94 enrolled
University of Oxford
National Institute for Health Research, United Kingdom · collabUniversity of Leicester · collabWellcome Trust · collab
RandomizedParallel-groupTriple-blindOther
Summary
TB043 is a clinical challenge trial primarily to evaluate the safety of BCG challenge administered by the aerosol inhaled route in healthy, BCG naive (Group 1-7) as well as historically BCG vaccinated UK adults (Group 8) . The trial will also look to evaluate and compare the amount of BCG recovered from the lungs as various points after challenge.
Timeline
- Start
- 2019-04-19
- Primary completion
- 2024-06
- Completion
- 2024-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BCG Danish | Vaccine | 1e+06 unknown | Inhaled |
| Subject | BCG Danish | Vaccine | 1e+07 unknown | Inhaled |