TuberculosisPhase 1NCT06845358
Safety and Challenge Study of BCG TICE(R) Vaccination to Test Tuberculosis Immunity in Heathy Humans
A Phase 1 study testing BCG TICE strain, Sodium Chloride, 0.9% and Sterile Water for Injection in people with Tuberculosis, run by National Institute of Allergy and Infectious Diseases (NIAID).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- BCG TICE strain, Sodium Chloride, 0.9% and Sterile Water for Injection
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 26 Nov 2025to 1 Sep 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- Women of childbearing potentialNot sterilized via tubal ligation, bilateral oophorectomy, hysterectomy, or < 1 year of the last menses if menopausal.
- Must agree to use highly effective contraception (defined as those that result in a failure rate with correct use of less than 1 percent per year) from 30 days prior to receipt of the first dose of investigational product until at least 3 months after receipt of the last administration.
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- Includes the following methods used alone: bilateral tubal ligation/bilateral salpingectomy, intrauterine system (IUS)/intrauterine device (IUD), estrogen/progestin-only oral, injectable, and implantable contraceptives, and abstinence when it is a consistent lifestyle choice.
- The following methods must be used together: male condom with a female non-condom barrier method (including diaphragm, cervical cap, contraceptive sponge, vaginal spermicide), female condom with diaphragm, cervical cap, contraceptive sponge, vasectomy with female barrier method (including female condom, diaphragm, cervical cap, contraceptive sponge, vaginal spermicide).
- Are in good health, as judged by the investigator and determined by vital signs, medical history, physical examination, and safety labs within normal range*.
- Oral temperature, pulse rate (PR), and blood pressure (BP), medical history, physical examination, and safety labs within normal ranges (except creatinine and alanine transaminase [ALT] levels below the normal ranges that will not be considered clinically significant abnormalities). Baseline screening labs should fall within the normal range of the clinical reference lab.
- 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..
- Have a urine dipstick that is negative for glucose and is less than 1 for protein at all screening visits.
- Ability to understand and complete all study visits as required per protocol and be reachable by telephone.
- Male participants must refrain from donating sperm from the screening visit until at least 12 weeks after the last administration.
Who cannot join
- Have a history of suspected, confirmed, treated, or have other evidence of active tuberculosis, including a positive PPD skin test*
- Symptoms of pulmonary tuberculosis (TB) may include productive cough for more than two or three weeks in duration, lymphadenopathy, fever, night sweats, unintentional weight loss in a person with known or possible TB exposure, and/or past or present residence in or travel to an area where TB is endemic.
- Have any systemic symptoms within 72 hours prior to BCG administration or signs of acute febrile illness (AFI) or acute respiratory illness (ARI)**
- (e.g., fever, cough, rhinorrhea, etc.) before TICE(R) BCG administration or signs of lymphadenopathy, hepatosplenomegaly, or pulmonary disease by physical exam on day of TICE(R) BCG administration.
- Have history of any significant acute or chronic medical conditions related to immunosuppression***.
- Such as impaired immunocompromised state due to chronic or acute disease or receipt of immunosuppressant drugs or therapies, including steroids, alkylating agents, antimetabolites, or radiation.
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- 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.
- Have a known allergy to any TICE(R) BCG components.
- Received blood products or immunoglobulin within six months prior to TICE(R) BCG administration.
- Received immunotherapy within one year prior to TICE(R) BCG administration.
- Received or plan to receive live attenuated vaccines four weeks before or after TICE(R) BCG administration.
- Received or plan to receive inactivated or killed vaccines two weeks before or after TICE(R) BCG administration.
- Plans to enroll in another clinical trial that could interfere with safety assessment of the study product at any time during the study period.
- Received an experimental agent within 30 days prior to TICE(R) BCG administration or planned receipt of an experimental agent within 90 days after TICE(R) BCG administration.
- Have a history of use of a systemic antibiotic within 14 days prior to TICE(R) BCG administration or planned use of a systemic antibiotic within three months after TICE(R) BCG administration.
- Anyone working as a healthcare provider during the trial.
- Are breastfeeding or plan to breastfeed at any given time throughout the study.
- Have a history of alcohol or drug abuse in the last five years.
- Have a BMI < 18.5 or >/= 35.
- Current or history of eczema and psoriasis.
- Received prior BCG vaccination (prior to participation in this study).
- History of infection with pulmonary or extrapulmonary Nontuberculous Mycobacteria (NTM).
- Currently living with someone or in close contact with someone with active TB.
- PPD skin test within two months prior to TICE(R) BCG administration or receipt during the study.
- Participants who meet eligibility criteria for Group A, but decline will not be eligible to enroll in Group B.
About this study
Official title: 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
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.
Read the 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
- Being tested
- BCG TICE strain, Sodium Chloride, 0.9%, Sterile Water for Injection
- Keywords
- BCG Vaccination, Intradermal, Open-label, Phase 1, Protective Immunity, Tuberculosis
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCG TICE strainBiological
BCG TICE strain is an attenuated, live culture preparation of the BCG strain of Mycobacterium bovis.
Sodium Chloride, 0.9%Other
0.9% Sodium Chloride Injection
Sterile Water for InjectionOther
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
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Subjects will receive 0.1 mL dose of 2x10^6 colony-forming units (CFU) Bacille Calmette-Guerin (BCG) TICE (R) vaccine, administered intradermally over the deltoid muscle of the preferred arm on Day 1. Subjects will then be challenged with 0.1mL of 4x10^6 colony-forming units (CFU) Bacille Calmette-Guerin (BCG) TICE (R) administered intradermally 6 months after vaccination. N=32 Receives: Biological: BCG TICE strain; Other: Sodium Chloride, 0.9%; Other: Sterile Water for Injection |
| Arm 2 | Experimental | Subjects will receive a 0.1mL dose of 4x10^6 colony-forming units (CFU) Bacille Calmette-Guerin (BCG) TICE (R) administered intradermally over the deltoid muscle of the preferred arm after complete enrollment of Arm 1 subjects. N=32 Receives: Biological: BCG TICE strain; Other: Sodium Chloride, 0.9%; Other: Sterile Water for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 181 through Day 237
Secondary outcomes (10)
Analyze the adaptive immune responses associated with immunogenicity and reactogenicity
Measured using IFN-gamma ELISPOT assay
Measured: Day 181 through Day 279
Comparison of area under the curve (AUC) for repeated measures of shedding over time from MGIT BACTEC assays intradermal (ID) TICE (R) Bacille Calmette-Guerin (BCG) challenge between unvaccinated and vaccinated groups.
Measured: Day 4 through Day 57
Distribution of the area under the curve (AUC) for repeated measures of shedding over time from colony-forming units (CFU) assays after intradermal (ID) TICE (R) Bacille Calmette-Guerin (BCG) challenge.
Measured: Days 4 through Day 57
Distribution of the area under the curve (AUC) for repeated measures of shedding over time from quantitative reverse transcription polymerase chain reaction (qRT-PCR) assays after intradermal (ID) TICE (R) Bacille Calmette-Guerin (BCG) challenge.
Measured: Days 4 through Day 57
Medically Attended Adverse Events (MAAEs) and Serious adverse events related to intradermal (ID) TICE (R) Bacille Calmette-Guerin (BCG) administration after vaccination
Measured: Day 1 through Day 181
Test correlations between interferon gamma (IFN-gamma) ELISPOT responses and Bacille Calmette-Guerin (BCG) shedding
Measured: Day 181 through Day 279
The number of participants experiencing Grade 3 (severe) injection site reactions following intradermal (ID) TICE (R) Bacille Calmette-Guerin (BCG) vaccination.
Measured: Day 1 through Day 30
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) vaccination.
Measured: Day 1 through Day 181
The number of participants experiencing Grade 3 (severe) or higher solicited systemic reactions following intradermal (ID) TICE (R) Bacille Calmette-Guerin (BCG) vaccination.
Measured: Day 1 through Day 30
The number of participants reporting Grade 3 (severe) or higher adverse events (AEs) related to intradermal (ID) TICE (R) Bacille Calmette-Guerin (BCG) vaccination
Measured: Day 1 through Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start26 Nov 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Why it stopped: Study not implemented due to funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06845358
- Sponsor's protocol ID
- 22-0011
- Other IDs
- 5UM1AI148684-03
- Status last verified
- 15 May 2025
- First submitted
- 20 Feb 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06845358
- Acronym / sponsor ID
- 22-0011
- Conditions
- Tuberculosis
- Keywords
- BCG Vaccination, Intradermal, Open-label, Phase 1, Protective Immunity, Tuberculosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not implemented due to funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 26 Nov 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Biological: BCG TICE strain, Other: Sodium Chloride, 0.9%, Other: Sterile Water for InjectionSubjects will receive 0.1 mL dose of 2x10^6 colony-forming units (CFU) Bacille Calmette-Guerin (BCG) TICE (R) vaccine, administered intradermally over the deltoid muscle of the preferred arm on Day 1. Subjects will then be challenged with 0.1mL of 4x10^6 colony-forming units (CFU) Bacille Calmette-Guerin (BCG) TICE (R) administered intradermally 6 months after vaccination. N=32 |
| Arm 2 | Experimental | Biological: BCG TICE strain, Other: Sodium Chloride, 0.9%, Other: Sterile Water for InjectionSubjects will receive a 0.1mL dose of 4x10^6 colony-forming units (CFU) Bacille Calmette-Guerin (BCG) TICE (R) administered intradermally over the deltoid muscle of the preferred arm after complete enrollment of Arm 1 subjects. N=32 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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.
- Women of childbearing potentialNot sterilized via tubal ligation, bilateral oophorectomy, hysterectomy, or < 1 year of the last menses if menopausal.
Key exclusion criteria (29 listed)
- Have a history of suspected, confirmed, treated, or have other evidence of active tuberculosis, including a positive PPD skin test*
- Symptoms of pulmonary tuberculosis (TB) may include productive cough for more than two or three weeks in duration, lymphadenopathy, fever, night sweats, unintentional weight loss in a person with known or possible TB exposure, and/or past or present residence in or travel to an area where TB is endemic.
- Have any systemic symptoms within 72 hours prior to BCG administration or signs of acute febrile illness (AFI) or acute respiratory illness (ARI)**
- (e.g., fever, cough, rhinorrhea, etc.) before TICE(R) BCG administration or signs of lymphadenopathy, hepatosplenomegaly, or pulmonary disease by physical exam on day of TICE(R) BCG administration.
- Have history of any significant acute or chronic medical conditions related to immunosuppression***.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCG TICE strainBCG TICE strain is an attenuated, live culture preparation of the BCG strain of Mycobacterium bovis. | Biological | Arm 1, Arm 2 |
| Sodium Chloride, 0.9%0.9% Sodium Chloride Injection | Other | Arm 1, Arm 2 |
| Sterile Water for InjectionA 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 | Other | Arm 1, Arm 2 |
Primary outcome
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 181 through Day 237
10 secondary outcomes
Analyze the adaptive immune responses associated with immunogenicity and reactogenicity
Time frame: Day 181 through Day 279
Comparison of area under the curve (AUC) for repeated measures of shedding over time from MGIT BACTEC assays intradermal (ID) TICE (R) Bacille Calmette-Guerin (BCG) challenge between unvaccinated and vaccinated groups.
Time frame: Day 4 through Day 57
Distribution of the area under the curve (AUC) for repeated measures of shedding over time from colony-forming units (CFU) assays after intradermal (ID) TICE (R) Bacille Calmette-Guerin (BCG) challenge.
Time frame: Days 4 through Day 57
Distribution of the area under the curve (AUC) for repeated measures of shedding over time from quantitative reverse transcription polymerase chain reaction (qRT-PCR) assays after intradermal (ID) TICE (R) Bacille Calmette-Guerin (BCG) challenge.
Time frame: Days 4 through Day 57
Medically Attended Adverse Events (MAAEs) and Serious adverse events related to intradermal (ID) TICE (R) Bacille Calmette-Guerin (BCG) administration after vaccination
Time frame: Day 1 through Day 181
Test correlations between interferon gamma (IFN-gamma) ELISPOT responses and Bacille Calmette-Guerin (BCG) shedding
Time frame: Day 181 through Day 279
The number of participants experiencing Grade 3 (severe) injection site reactions following intradermal (ID) TICE (R) Bacille Calmette-Guerin (BCG) vaccination.
Time frame: Day 1 through Day 30
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) vaccination.
Time frame: Day 1 through Day 181
The number of participants experiencing Grade 3 (severe) or higher solicited systemic reactions following intradermal (ID) TICE (R) Bacille Calmette-Guerin (BCG) vaccination.
Time frame: Day 1 through Day 30
The number of participants reporting Grade 3 (severe) or higher adverse events (AEs) related to intradermal (ID) TICE (R) Bacille Calmette-Guerin (BCG) vaccination
Time frame: Day 1 through Day 57
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BCG TICE strain, Sodium Chloride, 0.9% and Sterile Water for Injection in people with Tuberculosis, run by National Institute of Allergy and Infectious Diseases (NIAID).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Day 185 through Day 237). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.