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Phase 2a ID93 + GLA-SE Vaccine Trial in TB Patients After Treatment Completion

NCT02465216 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-03-12

Study results available
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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

  • Pulmonary Tuberculosis

Interventions

OTHER

Placebo

Placebo

BIOLOGICAL

ID93 + GLA-SE

ID93 + GLA-SE

Sponsors & Collaborators

  • Wellcome Trust

    collaborator OTHER

  • South African Tuberculosis Vaccine Initiative

    collaborator OTHER

  • Access to Advanced Health Institute (AAHI)

    lead OTHER

Principal Investigators

  • Mark Hatherill, MD · South African Tuberculosis Vaccine Initiative

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • South Africa

Study Locations

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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 NCT02465216 on ClinicalTrials.gov