drugset / Trial / NCT01599897
Phase 1 ID93 + GLA-SE Vaccine Trial in Healthy Adult Volunteers
Phase 1
Completed
60 enrolled
Access to Advanced Health Institute (AAHI)
Aeras · collabPaul G. Allen Family Foundation · collab
RandomizedSingle-groupSingle-blindPrevention
Summary
The purpose of this study is to determine the safety, tolerability, and immunogenicity in healthy adult subjects of an investigational vaccine being developed for the prevention of pulmonary tuberculosis. The vaccine, identified as ID93 + GLA-SE, consists of the recombinant four-antigen Mycobacterium tuberculosis recombinant protein ID93 together with the adjuvant GLA-SE.
Timeline
- Start
- 2012-08
- Primary completion
- 2014-05
- Completion
- 2014-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GLA-SE | Other / unclassified | 2 ug | Intramuscular |
| Subject | GLA-SE | Other / unclassified | 5 ug | Intramuscular |
| Subject | ID93 | Protein / enzyme biologic | 2 ug | Intramuscular |
| Subject | ID93 | Protein / enzyme biologic | 10 ug | Intramuscular |