BCG (Travel vaccine)

Vaccine Platform

Mycobacterial – Live Attenuated

Phase of Development

Phase 3

Candidate Overview

The purpose of this trial (TIPI Trial), is to find out if a single dose of pre-travel vaccination with BCG can lessen tuberculosis (TB) infection by producing an immune response when given to adults traveling to countries with a high burden of TB. BCG (Tokyo 172), supplied by Japan BCG Lab, will be compared with a placebo. BCG (Tokyo 172) is used globally but is not approved for use in the United States, therefore it is considered experimental. The purpose of this study is to inform public health, neither the study sponsor nor Japan BCG Lab are seeking licensure based on this trial.

Sponsor / Lead Developer: Henry M. Jackson Foundation for the Advancement of Military Medicine

Primary Indication: Prevention of Mtb infection or sustained infection

Target Population(s): Adults

Clinical Trials

Registry NumberNCT04453293
Clinical Trial PhasePhase 3
Primary endpoint(s) for this clinical trialPrevention of Mtb infection or sustained infection
Target population(s) for clinical trialAdults
People without Mtb infection