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MTBVAC Study in Adults With and Without Latent Tuberculosis Infection in South Africa

NCT02933281 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2023-02-27

No results posted yet for this study

Summary

MTBVAC at four dose levels: 5 x 10\^3 CFU, 5 x 10\^4 CFU, 5 x 10\^5 CFU, and 5 x 10\^6 CFU. The active control is BCG (5 x 10\^5 CFU). Participants will receive a single dose of MTBVAC or BCG revaccination administered intradermally on Study Day 0.

Conditions

Interventions

BIOLOGICAL

MTBVAC

Escalating dose levels (5 x 10\^3 CFU, 5 x 10\^4 CFU, 5 x 10\^5 CFU, and 5 x 10\^6 CFU

BIOLOGICAL

BCG

BCG 5 x 10\^5 CFU

Sponsors & Collaborators

  • Biofabri, S.L

    collaborator INDUSTRY

  • Universidad de Zaragoza

    collaborator OTHER

  • South African Tuberculosis Vaccine Initiative

    collaborator OTHER

  • International AIDS Vaccine Initiative

    lead NETWORK

Principal Investigators

  • Angelique Luabeya, MD · SATVI

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-14
Primary Completion
2021-09-05
Completion
2021-09-05
FDA Drug
Yes

Countries

  • South Africa

Study Locations

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Entities

Drugs
Diseases

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 NCT02933281 on ClinicalTrials.gov