drugset / Trial / NCT03265977
A Phase II Study of H56:IC31 in Healthy Adolescents
Phase 2
Withdrawn
Aeras
Aurum Institute · collabNational Institute for Medical Research, Tanzania · collabOslo University Hospital · collabSouth African Tuberculosis Vaccine Initiative · collabStatens Serum Institut · collabUniversity of Bergen · collabUniversity of Copenhagen · collab
RandomizedParallel-groupTriple-blindPrevention
Summary
This clinical trial will evaluate safety, immunogenicity, and efficacy (prevention of Mtb infection as measured by IGRA conversions) of H56:IC31 in remotely BCG vaccinated adolescents.
Timeline
- Start
- 2018-06
- Primary completion
- 2021-04-30
- Completion
- 2021-06-30
Outcome
Outcome not reported
Stopped: “Design, sponsorship changed prior to initiation. No study procedures done.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | H56 | Protein / enzyme biologic | 5 ug | Intramuscular |
| Subject | IC31 | Other / unclassified | 0.0005 mmol | Intramuscular |