Bacille Calmette Guerin (BCG) Revaccination of Healthy Adolescents for the Prevention of Mycobacterium Tuberculosis Sustained Infection

Phase 2 Terminated 1836 enrolled Gates Medical Research Institute

RandomizedParallel-groupTriple-blindPrevention

Summary

The purpose of this study is to demonstrate the efficacy of Bacille Calmette Guerin (BCG) revaccination against sustained Mycobacterium tuberculosis infection versus placebo in previously BCG vaccinated QuantiFERON®-TB Gold Plus Assay (QFT) negative, healthy adolescents.

Timeline

Start: 2019-10-16
Primary completion: 2024-05-14
Completion: 2024-05-14

Outcome

Missed primary endpoint

Stopped (Business): “Sponsor decision”

registry p = 0.6193; Hazard Ratio (HR) 1.049 (95% CI 0.770 to 1.431); Log Rank NCT04152161 ↗

paper BCG revaccination in QFT-test negative, HIV-negative adolescents did not provide protection from sustained M. tuberculosis infection. PMID 40334156 ↗

Publications

Schmidt AC, Fairlie L, Hellstrom E, Luabeya Kany Kany A, Middelkoop K, Naidoo K, Nair G, Gela A, Nemes E, Scriba TJ, Cinar A, Frahm N, Mogg R, Kaufman D, Dunne MW, Hatherill M; BCG REVAX Study Team. BCG Revaccination for the Prevention of Mycobacterium tuberculosis Infection. N Engl J Med. 2025 May 8;392(18):1789-1800. doi: 10.1056/NEJMoa2412381.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BCG vaccine SSI	Vaccine	0.1 ml	Other