Safety and Challenge Study of BCG TICE(R) Vaccination to Test Tuberculosis Immunity in Heathy Humans (NCT06845358) | Clinical Trial Compass
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 range
18 Years – 45 Years
Sex
ALL
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
2
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
3
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
4
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
5
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
6
The number of participants reporting Grade 3 (severe) or higher adverse events (AEs) related to intradermal (ID) TICE (R) Bacille Calmette-Guerin (BCG) challenge
Trial details
NCT IDNCT06845358
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. 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
. Have a history of suspected, confirmed, treated, or have other evidence of active tuberculosis, including a positive PPD skin test\*
. Have any systemic symptoms within 72 hours prior to BCG administration or signs of acute febrile illness (AFI) or acute respiratory illness (ARI)\*\*
. Have history of any significant acute or chronic medical conditions related to immunosuppression\*\*\*.
. Chronic medications that, in the opinion of the investigator, will interfere with immunity or affect safety.
. Receipt of \>/= 20 milligrams (mg)/day of prednisone or equivalent for \>/= 14 consecutive days in a four-week period prior to signing the informed consent.
. Have any history of excessive scarring or keloid formation.
. Have household contact or occupation involving significant close contact, such as living with or directly working with someone who is immunocompromised.
. Have a pacemaker, prosthetic valve, or implantable cardiac devices, endovascular grafts, prosthetic joint implants, intramedullary nails, or titanium brain implants.