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MTBVAC Study in Adults With and Without Latent Tuberculosis Infection in South Africa — A-050  

Tuberculosis Clinical Trial

Official title:
MTBVAC Phase 1b/2a Randomized, Double-blind, Active-controlled,Safety, Immunogenicity, and Dose-escalation Study in Adults With and Without Latent Tuberculosis Infection in South Africa

Clinical Trial 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.

Clinical Trial Description

This is a Phase 1b/2a, double-blind, randomized, BCG-controlled, dose-escalation safety and immunogenicity study in 144 healthy adults with and without LTBI. All participants will have received previous BCG vaccination in infancy. The investigational product is 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 meeting the inclusion/exclusion criteria will be randomized within a study cohort to receive a single dose of MTBVAC or BCG revaccination administered intradermally on Study Day 0. The study will be conducted at one site in South Africa. Participants will be enrolled into one of eight cohorts and followed for safety and immunogenicity endpoints through Study Day 365. The estimated time to complete enrolment is approximately 12 months. Cohorts 1-8 will include 72 QFT-negative (Cohorts 1-4) and 72 QFT-positive (Cohorts 5-8) participants. Participants will be randomized within each cohort, to receive either MTBVAC (N=96) or BCG (N=48). The cohorts will be enrolled as described in the protocol, as long as no pausing/stopping rules are triggered ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02933281
Study type Interventional
Source International AIDS Vaccine Initiative
Contact
Status Completed
Phase Phase 1/Phase 2
Start date May 14, 2018
Completion date September 5, 2021
View Details
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