Phase 1 ID93 + GLA-SE Vaccine Trial in BCG-Vaccinated Healthy Adult Volunteers
NCT01927159 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66
Last updated 2018-02-01
Summary
The purpose of this study is to determine the safety, tolerability, and immunogenicity in BCG-vaccinated healthy adult subjects of an investigational vaccine being developed for the prevention of pulmonary tuberculosis.
Conditions
- Pulmonary Tuberculosis
Interventions
- BIOLOGICAL
-
ID93 + GLA-SE
- OTHER
-
Placebo
Sponsors & Collaborators
-
Aeras
collaborator OTHER -
South African Tuberculosis Vaccine Initiative
collaborator OTHER -
Access to Advanced Health Institute (AAHI)
lead OTHER
Principal Investigators
-
Michele Tameris, M.B.Ch.B. · SATVI
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2013-09-30
- Primary Completion
- 2015-07-31
- Completion
- 2015-07-31
Countries
- South Africa
Study Locations
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