Trials / Completed
CompletedNCT02465216
Phase 2a ID93 + GLA-SE Vaccine Trial in TB Patients After Treatment Completion
A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Evaluate the Safety and Immunogenicity of the ID93 + GLA-SE Vaccine in HIV Uninfected Adult TB Patients After Treatment Completion
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Access to Advanced Health Institute (AAHI) · Academic / Other
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and immunogenicity of ID93 + GLA-SE vaccine when administered to adult pulmonary Tuberculosis (TB) patients, following successful completion of TB treatment with confirmed bacteriologic cure, in preparation for a future Phase 2b prevention of TB recurrence trial in the same population.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Placebo | Placebo |
| BIOLOGICAL | ID93 + GLA-SE | ID93 + GLA-SE |
Timeline
- Start date
- 2015-06-01
- Primary completion
- 2017-01-01
- Completion
- 2017-01-01
- First posted
- 2015-06-08
- Last updated
- 2019-03-12
- Results posted
- 2018-11-09
Locations
3 sites across 1 country: South Africa
Source: ClinicalTrials.gov record NCT02465216. Inclusion in this directory is not an endorsement.