NCT06845358

Safety and Challenge Study of BCG TICE(R) Vaccination to Test Tuberculosis Immunity in Heathy Humans

A Phase 1 Open-Label Human Vaccination and Challenge Study to Assess the Ability of Intradermal BCG TICE(R) Vaccination to Induce Protective TB Immunity Capable of Inhibiting Replication In Vivo in Healthy Human Volunteers

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A nonrandomized, open-label trial will be conducted with a total of 64 healthy male and non-pregnant females, ages 18-45 years. Participants in Group A will enroll 32 participants to receive 2x10\^6 colony- forming units CFU TICE(R) BCG vaccination on Day 1 and 4x10\^6 CFU challenge on Day 181. Once enrollment has been completed in Group A, participants in Group B will be enrolled sequentially to receive 4x10\^6 CFU challenge. The primary objectives are to evaluate the safety of intradermal (ID) TICE(R) BCG for use as a human challenge model for Mycobacterium tuberculosis (Mtb) infection and to examine BCG shedding from challenge sites in participants who had received ID vaccination with TICE(R) BCG or were not vaccinated six months prior.

Detailed description

A nonrandomized, open-label trial will be conducted with a total of 64 healthy male and non-pregnant females, ages 18-45 years. Participants in Group A will enroll 32 participants to receive 2x10\^6 colony- forming units (CFU) TICE(R) BCG vaccination on Day 1 and 4x10\^6 CFU challenge on Day 181. Once enrollment has been completed in Group A, participants in Group B will be enrolled sequentially to receive 4x10\^6 CFU challenge. The primary objectives are to evaluate the safety of intradermal (ID) TICE(R) BCG for use as a human challenge model for Mycobacterium tuberculosis (Mtb) infection and to examine BCG shedding from challenge sites in participants who had received ID vaccination with TICE(R) BCG or were not vaccinated six months prior. The secondary objectives are to 1) evaluate the safety of ID TICE(R) BCG after vaccination, 2) examine BCG shedding by MGIT assay from challenge sites in participants who had received ID vaccination with TICE(R) BCG or were not vaccinated six months prior, 3) examine BCG shedding from challenge sites in participants that had received ID vaccination with TICE(R) BCG or were not vaccinated six months prior using additional assays, 4) characterize the T cell responses after BCG challenge in participants that received ID vaccination with TICE(R) BCG or not vaccinated six months prior and 5) determine whether IFN-gamma correlates with levels of BCG shedding.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
BIOLOGICAL	BCG TICE strain	BCG TICE strain is an attenuated, live culture preparation of the BCG strain of Mycobacterium bovis.
OTHER	Sodium Chloride, 0.9%	0.9% Sodium Chloride Injection
OTHER	Sterile Water for Injection	A sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection

Timeline

• Start date: 2025-11-26
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2025-02-25
• Last updated: 2025-12-17

Regulatory

• FDA-regulated drug study