WithdrawnPhase 1

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

Stopped: Study not implemented due to funding.

0Started 2025-11-26

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Provide written informed consent prior to initiation of any study procedures.
✓. Stated willingness to be available for all study visits and comply with all trial procedures throughout the duration of the trial.
✓. Are males or non-pregnant females between the ages of 18 and 45 years, inclusive, at the time of enrollment.
✓. For women of childbearing potential, negative serum pregnancy test at screening and negative urine pregnancy test within 24 hours prior to vaccination and challenge of TICE(R) BCG.
✓. Are in good health, as judged by the investigator and determined by vital signs, medical history, physical examination, and safety labs within normal range\*\*\*\*\*.
✓. Have a negative HIV-1 ELISA test at first screening visit.
✓. Have negative serology tests for hepatitis B surface antigen and hepatitis C virus antibody at first screening visit.
✓. Have a negative QuantiFERON(R) - (tuberculosis)TB Gold test at first screening visit..

Exclusion criteria

What they're measuring

Distribution of the area under the curve (AUC) for repeated measures of shedding over time from mycobacteria growth indicator tube (MGIT) BACTEC assays after intradermal (ID) TICE (R) Bacille Calmette-Guerin (BCG) challenge

Timeframe: Day 185 through Day 237

Serious adverse events (SAE) and/ or Medically Attended Adverse Events (MAAEs) related to intradermal (ID) TICE (R) Bacille Calmette-Guerin (BCG) challenge

Timeframe: Day 181 through Day 361

The number of participants experiencing Grade 3 (severe) or higher clinical safety laboratory adverse events (AEs) following intradermal (ID) TICE(R) Bacille Calmette-Guerin (BCG) challenge

Timeframe: Day 181 through Day 188

The number of participants experiencing Grade 3 (severe) or higher solicited injection site reactions following intradermal (ID) TICE(R) Bacille Calmette-Guerin (BCG) challenge

Timeframe: Day 181 through Day 236

The number of participants experiencing Grade 3 (severe) or higher solicited systemic reactions following intradermal (ID) TICE(R) Bacille Calmette-Guerin (BCG) challenge

Timeframe: Day 181 through Day 195

The number of participants reporting Grade 3 (severe) or higher adverse events (AEs) related to intradermal (ID) TICE (R) Bacille Calmette-Guerin (BCG) challenge

Timeframe: Day 181 through Day 237

Trial details

NCT IDNCT06845358

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2026-09-01

View on ClinicalTrials.gov More Tuberculosis trials