NCT04152161

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

A Randomized, Placebo Controlled, Observer-Blind, Phase IIb Study to Evaluate the Efficacy, Safety, and Immunogenicity of BCG Revaccination in Healthy Adolescents for the Prevention of Sustained Infection With Mycobacterium Tuberculosis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,836 (actual)
• Sponsor: Gates Medical Research Institute · Academic / Other
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
BIOLOGICAL	BCG vaccine SSI	Participants will receive a single 0.1 milliliter (mL) volume of BCG vaccine SSI, administered intradermally in deltoid region of the upper arm.
BIOLOGICAL	Placebo	Participants will receive a single 0.1 mL volume of normal saline, administered intradermally in deltoid region of the upper arm.

Timeline

• Start date: 2019-10-16
• Primary completion: 2024-05-14
• Completion: 2024-05-14
• First posted: 2019-11-05
• Last updated: 2025-06-19
• Results posted: 2025-06-19

Locations

5 sites across 1 country: South Africa