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Study to Evaluate H56:IC31 in Preventing Rate of TB Recurrence

NCT03512249 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 831

Last updated 2026-02-24

Study results available
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Summary

This is a phase 2, double-blind, randomized (1:1), placebo-controlled trial with two parallel groups.

* H56:IC31 (investigational vaccine)
* Placebo

900 HIV-negative adults with a diagnosis of drug susceptible pulmonary TB are planned to be included, recruited from TB clinics with established relationships to the trial sites at the start of their TB treatment.

5 study sites in South Africa: 2 sites from the AURUM institute (Klerksdorp and Tembisa) and 3 in Cape Town at TASK Applied Science (TASK), the University of Cape Town Lung Institute (UCTLI) and South African Tuberculosis Vaccine Initiative (SATVI) under UCT, respectively.

1 study site in Tanzania (TZ): 1 site at Mbeya Medical Research Centre (MMRC) under the National Institute for Medical Research (NIMR).

Conditions

  • Tuberculosis, Pulmonary

Interventions

BIOLOGICAL

H56:IC31

5ug H56/500 nmol IC31

BIOLOGICAL

Placebo

Sterile saline for injection

Sponsors & Collaborators

  • Statens Serum Institut

    collaborator OTHER

  • University of Cape Town Lung Institute

    collaborator OTHER

  • TASK Applied Science

    collaborator OTHER

  • The Aurum Institute NPC

    collaborator OTHER

  • National Institute for Medical Research, Tanzania

    collaborator OTHER_GOV

  • Ospedale San Raffaele

    collaborator OTHER

  • European and Developing Countries Clinical Trials Partnership (EDCTP)

    collaborator OTHER_GOV

  • South African Tuberculosis Vaccine Initiative

    collaborator OTHER

  • International AIDS Vaccine Initiative

    lead NETWORK

Principal Investigators

  • Marissa Russell · IAVI (previously Aeras)

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
2019-01-31
Primary Completion
2023-03-20
Completion
2023-03-20

Countries

  • South Africa
  • Tanzania

Study Locations

More Related Trials

Entities

Drugs

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 NCT03512249 on ClinicalTrials.gov