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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00052195 on ClinicalTrials.gov