Investigational Vaccine for the Prevention of Disseminated Tuberculosis in HIV Infected People
NCT00052195 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1975
Last updated 2016-02-19
Summary
A significant number of HIV infected patients in Africa also have disseminated tuberculosis (infection throughout multiple organs). This type of tuberculosis is a significant cause of mortality in these patients. The purpose of this study is to evaluate the safety and effectiveness of a vaccine designed to prevent disseminated tuberculosis.
Conditions
- Tuberculosis
- HIV Infections
Interventions
- BIOLOGICAL
-
SRL-172
5 doses of 0.1mL vaccine or placebo given intradermally over 12-months
Sponsors & Collaborators
-
National Institute of Allergy and Infectious Diseases (NIAID)
collaborator NIH -
Dartmouth-Hitchcock Medical Center
lead OTHER
Principal Investigators
-
C. Fordham F von Reyn, MD · Dartmouth-Hitchcock Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2001-09-30
- Primary Completion
- 2008-12-31
- Completion
- 2009-05-31
Countries
- Tanzania
Study Locations
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