Tuberculosis InfectionPhase 3TIPINCT04453293
Immunization With BCG Vaccine to Prevent Tuberculosis Infection
A Phase 3 study testing BCG (Tokyo 172) vaccine in people with Tuberculosis Infection, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 7 sites in United States.
Trial summary
The purpose of this research is to find out if a single dose of pre-travel vaccination with BCG can lessen tuberculosis (TB) infection by producing an immune response when given to adults traveling to countries with a high or moderate burden of TB. BCG will be compared with a placebo (an inactive vaccine). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis Infection
- What is being tested?
- BCG (Tokyo 172) vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Dec 2021to 16 Jan 2026
- Phase
- Phase 3
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants will be eligible for study participation if they meet all of the following criteria:
- Participant is willing to participate in the study as evidenced by providing voluntary written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization prior to conducting any trial related procedures
- Participant is male or female, age ≥ 18 years and ≤ 65 years at time of consent
- Participant is in good general health, confirmed by medical history, laboratory screening, and physical examination
- Participant has no known history of Mtb infection
- Participant has no prior history of BCG vaccination, or previous receipt of an investigational Mtb vaccine
Show all 16Show fewer
- Participant is assessed to be at risk for TB exposure (particularly drug resistant TB) during planned travel and has planned to work in high or moderate TB burden countries for a duration of a minimum of 10 days and not greater than 6 months for HCW
- Participant presents at least 4 weeks prior to travel departure
- Participant is willing to forego any periodic tuberculin skin test screening procedures for 6 months after receiving BCG/placebo vaccine
- Participant is willing to wait after receiving a COVID-19 vaccine for 7 days before receiving BCG/placebo vaccine
- Participant is willing to complete all study visits as required by the protocol and is reachable by telephone or email during the study
- Participant agrees to medical record access for purposes of relevant medical history collection
- For Females of Childbearing Potential Only:
- Participant has a negative urine pregnancy test prior to starting study treatment
- Participant is willing to use effective contraception for at least 30 days before and 6 weeks after BCG/placebo vaccination
- Lactating female that is willing to refrain from breast-feeding for 6 weeks post-vaccination
Who cannot join
- Participants will be ineligible for study participation if they meet any of the following criteria:
- Participant has known positive tuberculin skin test (>10 mm) or positive IGRA
- Participant has medical condition for which BCG vaccination is contraindicated (e.g., HIV or other immunocompromised conditions)
- Participant is currently receiving (within last 30 days) immune-compromising treatments, such as TNF-α blockade
- Participant has history of chronic (≥ 30 days) oral steroid use or intravenous (IV) steroids within the last 90 days
- Participant has received radiation therapy or chemotherapy within the last 180 days
Show all 20Show fewer
- Participant has received BCG treatment for bladder cancer
- Participant is female and is pregnant (as defined by positive urine βHCG test) or intends to become pregnant in next 3 months, or is breast-feeding at screening or vaccination visit
- Participant is unwilling to complete all required study elements (e.g., HIV testing)
- Participant has received 2 or more live vaccinations (e.g., measles and yellow fever) within 30 days prior to receipt of BCG/placebo vaccine (Visit 2)
- Participant has known or suspected hypersensitivity to BCG vaccine or related products
- Participant has positive/borderline IGRA test at screening
- Participant has positive/indeterminate HIV test at screening unless has received prior HIV vaccine
- Participant has a history of life-threatening adverse event following receipt of any immunization
- Participant is known to have a behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand or cooperate with the requirements of the study protocol
- Participant has other concurrent condition(s) that in the opinion of the investigator would jeopardize the safety or rights of a participant participating in the trial or would render the participant unable to comply with the protocol and/or compromise study objectives
- Participant has had tuberculin skin testing performed within 1 month prior to Visit 1
- Participant has received a COVID-19 vaccine within 7 days prior to BCG/placebo vaccine
- Participant has had a probable exposure to TB (defined as to someone with suspected or confirmed pulmonary TB who is likely infectious) within 8-10 weeks of Visit 1
- Participant has prior history of nontuberculous mycobacterial disease, not colonization only
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Johns Hopkins Bloomberg School of Public Health, Department of International Health, Center for Immunization Research
Baltimore, Maryland, 21205
The Brigham and Women's Hospital Center for Clinical Investigation
Boston, Massachusetts, 02115
Hope Clinic of the Emory University Vaccine Center, Emory University
Decatur, Georgia, 30030
Baylor College of Medicine
Houston, Texas, 77030
Yale University School of Medicine
New Haven, Connecticut, 06510
University of Utah School of Medicine
Salt Lake City, Utah, 84108
MedStar Washington Hospital Center/MedStar Health Research Institute
Washington D.C., District of Columbia, 20010
About this study
Official title: A Proof-of Concept, Randomized, Controlled Study of Tuberculosis Immunization With BCG to Prevent Infection in Healthy Adults (TIPI Trial)
The purpose of this research is to find out if a single dose of pre-travel vaccination with BCG can lessen tuberculosis (TB) infection by producing an immune response when given to adults traveling to countries with a high or moderate burden of TB. BCG will be compared with a placebo (an inactive vaccine). BCG (Japan) is used globally but is not approved for use in the United States, therefore it is considered experimental. Participants choosing to take part in this research study, will be randomly assigned (this is like a coin flip) to BCG or placebo. 2000 eligible volunteers will be enrolled.
Read the detailed description
This study is a multi-center, prospective, randomized, placebo-controlled, participant and laboratory-blinded clinical trial to evaluate a single pre-travel vaccination with investigational freeze-dried glutamate BCG (Japan) to prevent Mycobacterium tuberculosis complex (Mtb) infection in healthy adult travelers, 18-65 years of age, exposed to persons with TB in high or moderate burden countries.
The goals of this study are both public health and scientific. The public health goal of this study is to offer possible protection against TB to US workers traveling abroad to work in countries with a high burden of TB where there is a risk for multidrug resistant/extensively drug resistant TB exposure and where effective TB infection control interventions are infrequently fully implemented. A long-term scientific goal is to test the hypothesis that TB vaccination prevents primary TB infection as measured by peripheral blood TB interferon gamma release assay (IGRA) conversion at return from travel visit, as well as sustained conversion at approximately 4-6 months post-return from travel. Rates of IGRA conversion in BCG-vaccinated recipients as compared to placebo recipients will be evaluated. Additionally, this study will collect information regarding exposure to and infection with TB, assessing risk factors for TB infection during the participant's travel.
This study will recruit health care workers (public health workers or students in training status) traveling to countries with a high or moderate burden of TB where there is a risk for multidrug resistant/extensively drug resistant (MDR/XDR) for a minimum of 10 days up through 6 months, with planned exposure to the local population such as patient care activities. Performance sites will not enroll anyone traveling for greater than 6 months or longer.
High or moderate TB burden countries for this study are defined as countries identified in the World Health Organization (WHO) Global Tuberculosis Report 2020 to have a TB incidence of ≥20/100,000. Targeted participant population of travelers at-risk for high TB exposure will work specifically in one or more of the 131 highest ranked TB burden countries as recognized by the WHO 2020 report.
Participants enrolled will be required to complete typically 4, but up to 6 study visits composed of: screening and eligibility assessments, vaccination with study vaccine (BCG or placebo), a subsequent post-vaccination follow-up assessment visit to identify potential adverse event occurrences, a post-travel follow-up visit to assess the risk factors for Mtb infection and assess the primary endpoint (IGRA conversion from negative to positive), and if applicable, an additional visit for those participants who are found to have a borderline IGRA result. For participants found to have post-travel IGRA conversion results, an additional visit will be requested for assessment of sustained TB IGRA conversion and reversion.
Different evaluations, tests and/or procedures to be performed during study visits include: interviews relevant to their medical history and general well-being between study visits; physical examinations and vital signs; completion of a pre-travel questionnaire and post-travel questionnaires to collect information regarding exposure to TB and risk factors for infection, as well as any information regarding development of active TB disease, both pulmonary and/or extrapulmonary and evaluation for the presence and severity of self-reported symptomatic all-cause respiratory infection occurrences while traveling abroad; keeping a record to assess for occurrence of local reactions at the injection site and incidence of selected symptoms for the first 14 days post-vaccination; and blood draws (2 up to 4 depending on what previous blood test results reveal).
The study design is endpoint driven; designed to observe 56 total IGRA conversions. Therefore, enrollment into this study will be stopped if the target endpoint (56 IGRA conversions) are met earlier than expected.
- Conditions
- Tuberculosis Infection
- Being tested
- BCG (Tokyo 172) vaccine, Placebo
- Keywords
- BCG Vaccine, Tuberculosis vaccine
- Medical subject headings
- Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCG (Tokyo 172) vaccineBiological
Freeze-Dried Glutamate Bacillus Calmette-Guérin BCG Vaccine (Japan BCG Laboratory), 0.1 mL given as single dose by intradermal injection over the outer lower aspect of the deltoid region
PlaceboDrug
Also called sodium glutamate
Placebo vaccine diluent, 0.1 mL given as single dose by intradermal injection over the outer lower aspect of the deltoid region
| Study group | Role | What they receive |
|---|---|---|
| BCG vaccine | Experimental | Freeze-dried Glutamate Bacillus Calmette-Guérin (BCG) (Tokyo 172) vaccine Receives: Biological: BCG (Tokyo 172) vaccine |
| Placebo | Placebo comparator | Vaccine diluent [sodium glutamate] Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in TB IGRA blood test results from baseline pre-travel and post-travel return
Conversion change of TB IGRA from pre-travel baseline value of negative to positive post-travel, using FDA-approved breakpoints as a measure of Mycobacterium tuberculosis infection. Response will be assessed using technology of the T-SPOT.TB test method. Specifically, the test measures the number of spots from T cells sensitized to TB infection on a plate containing 4 different antigens: nil (negative control), 2 TB antigens (ESAT-6 and CFP-10, also called Panel A and Panel B), and phytohemagglutinin (positive control). Results are interpreted by subtracting the spot count in the negative (NIL) control from the spot count in Panels A and B:
- Positive ≥ 8 spots
- Negative ≤ 4 spots (this includes values less than zero)
- Borderline 5, 6, or 7 spots
- Invalid
Measured: At baseline, and 8-10 weeks post-travel return
Secondary outcomes (5)
Number of Participants with sustained conversion and reversion in the TB IGRA converters
Participants identified as having positive TB IGRA blood test results will undergo a TB IGRA re-test to determine sustained (positive result) conversion and reversion (defined as negative/borderline) using the T-SPOT.TB test method. The rate of conversion for each study group will be calculated as the number of conversions divided by person-months of travel
Measured: 4-6 months from return post-travel
Number of Participants with history of TB disease/symptoms while deployed
Participants with response of symptoms suggestive of TB disease (i.e., bloody cough, cough ≥ 2 weeks, chest pain, fever ≥ 2 weeks, night sweats, and unintentional weight loss), development of active TB disease (possible, probable, or definite) and TB treatment that may have occurred during travel to high or moderate burden TB country or up to the time of IGRA testing.
Measured: Through final IGRA testing, expected average time 8-10 weeks post-travel return
Identify potential risk factors for Mtb infection in the targeted study population collected on Post-Travel Questionnaire
Questionnaire responses from participants after travel will collect information regarding exposure to TB and risk factors for infection, as well as any information regarding risk reduction activities taken (i.e. personal protective measures) that may have occurred during travel to countries with high burden TB identified in the 2020 World Health Organization (WHO) TB report. Travelers will be asked if they had contact with anyone known to have TB disease or if they worked with populations at risk for HIV while abroad. They will also be asked about accommodations, daily routine, and if they used public transportation such as mini-buses and if so, how frequently. A final open-ended question e.g., "Do you have reason to believe you were exposed?" will be asked of all travelers
Measured: Through final IGRA testing, expected average time 8-10 weeks post-travel return
Number of Participants with treatment-related adverse effects following intradermal administration of BCG vaccine
Post-vaccination response to assess for occurrence of selected local injection site reactions (pain/tenderness, redness, ulceration, drainage, vesicle [blister], induration [swelling] and scarring), axillary/ cervical lymphadenopathy, and selected systemic symptoms (fever, headache, chills, dizziness, tiredness, nausea, gastrointestinal problems, rash, muscle and joint pain and general well-being) using the 2007 U.S. FDA guidance Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. For each reaction, the highest grade will be determined for each traveler. Participants will be provided with a memory aid card to record any occurrences of selected local reactions and systemic symptoms that may occur during the first 14-days post-vaccination
Measured: Baseline (pre-administration of vaccine), within 30 minutes of vaccination, 14-days post-vaccination, and 2 to 6 weeks post-vaccination (Visit 3)
Number of Participants with self-reported symptoms of all-cause respiratory infections acquired while traveling abroad
Questionnaire responses obtained from participants will assess self-reported symptomatic all-cause respiratory infection symptoms in five domains (nose, throat, chest, systemic, neurological) for presence, frequency of occurrence and severity, impact of acute symptoms on functional activities or productivity, and medical care encounters and treatment as a result of respiratory illness while traveling abroad.
Measured: Through final IGRA testing, expected average time 8-10 weeks post-travel return
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start1 Dec 2021
- Primary completion16 Jan 2026
- Study completion16 Jan 2026
Why it stopped: The sponsor has elected to discontinue/terminate the study prematurely due to slower-than-anticipated recruitment and limited remaining research funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis InfectionStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled trial of BCG (Tokyo 172) vaccine single dose given intradermally compared to placebo vaccine (diluent) given intradermally single dose
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Uniformed Services University of the Health Sciences
- Responsible party
- Sponsor
- Investigators
- Naomi E. Aronson, MD, Study chair, Uniformed Services University of the Health SciencesMerlin L. Robb, MD, Study director, Henry M. Jackson Foundation for the Advancement of Military Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453293
- Sponsor's protocol ID
- 2019-01
- Other IDs
- BAA 170090
- Acronym
- TIPI
- Status last verified
- Jan 2026
- First submitted
- 17 Jun 2020
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof-of Concept, Randomized, Controlled Study of Tuberculosis Immunization With BCG to Prevent Infection in Healthy Adults (TIPI Trial)
- ClinicalTrials.gov ID
- NCT04453293
- Acronym / sponsor ID
- TIPI / 2019-01
- Conditions
- Tuberculosis Infection
- Keywords
- BCG Vaccine, Tuberculosis vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The sponsor has elected to discontinue/terminate the study prematurely due to slower-than-anticipated recruitment and limited remaining research funding.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- United States Department of Defense, Uniformed Services University of the Health Sciences
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 16 Jan 2026 (actual)
- Study completion
- 16 Jan 2026 (actual)
- First posted
- 1 Jul 2020 (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.
The purpose of this research is to find out if a single dose of pre-travel vaccination with BCG can lessen tuberculosis (TB) infection by producing an immune response when given to adults traveling to countries with a high or moderate burden of TB. BCG will be compared with a placebo (an inactive vaccine). BCG (Japan) is used globally but is not approved for use in the United States, therefore it is considered experimental. Participants choosing to take part in this research study, will be randomly assigned (this is like a coin flip) to BCG or placebo. 2000 eligible volunteers will be enrolled.
Detailed description
This study is a multi-center, prospective, randomized, placebo-controlled, participant and laboratory-blinded clinical trial to evaluate a single pre-travel vaccination with investigational freeze-dried glutamate BCG (Japan) to prevent Mycobacterium tuberculosis complex (Mtb) infection in healthy adult travelers, 18-65 years of age, exposed to persons with TB in high or moderate burden countries.
The goals of this study are both public health and scientific. The public health goal of this study is to offer possible protection against TB to US workers traveling abroad to work in countries with a high burden of TB where there is a risk for multidrug resistant/extensively drug resistant TB exposure and where effective TB infection control interventions are infrequently fully implemented. A long-term scientific goal is to test the hypothesis that TB vaccination prevents primary TB infection as measured by peripheral blood TB interferon gamma release assay (IGRA) conversion at return from travel visit, as well as sustained conversion at approximately 4-6 months post-return from travel. Rates of IGRA conversion in BCG-vaccinated recipients as compared to placebo recipients will be evaluated. Additionally, this study will collect information regarding exposure to and infection with TB, assessing risk factors for TB infection during the participant's travel.
This study will recruit health care workers (public health workers or students in training status) traveling to countries with a high or moderate burden of TB where there is a risk for multidrug resistant/extensively drug resistant (MDR/XDR) for a minimum of 10 days up through 6 months, with planned exposure to the local population such as patient care activities. Performance sites will not enroll anyone traveling for greater than 6 months or longer.
High or moderate TB burden countries for this study are defined as countries identified in the World Health Organization (WHO) Global Tuberculosis Report 2020 to have a TB incidence of ≥20/100,000. Targeted participant population of travelers at-risk for high TB exposure will work specifically in one or more of the 131 highest ranked TB burden countries as recognized by the WHO 2020 report.
Participants enrolled will be required to complete typically 4, but up to 6 study visits composed of: screening and eligibility assessments, vaccination with study vaccine (BCG or placebo), a subsequent post-vaccination follow-up assessment visit to identify potential adverse event occurrences, a post-travel follow-up visit to assess the risk factors for Mtb infection and assess the primary endpoint (IGRA conversion from negative to positive), and if applicable, an additional visit for those participants who are found to have a borderline IGRA result. For participants found to have post-travel IGRA conversion results, an additional visit will be requested for assessment of sustained TB IGRA conversion and reversion.
Different evaluations, tests and/or procedures to be performed during study visits include: interviews relevant to their medical history and general well-being between study visits; physical examinations and vital signs; completion of a pre-travel questionnaire and post-travel questionnaires to collect information regarding exposure to TB and risk factors for infection, as well as any information regarding development of active TB disease, both pulmonary and/or extrapulmonary and evaluation for the presence and severity of self-reported symptomatic all-cause respiratory infection occurrences while traveling abroad; keeping a record to assess for occurrence of local reactions at the injection site and incidence of selected symptoms for the first 14 days post-vaccination; and blood draws (2 up to 4 depending on what previous blood test results reveal).
The study design is endpoint driven; designed to observe 56 total IGRA conversions. Therefore, enrollment into this study will be stopped if the target endpoint (56 IGRA conversions) are met earlier than expected.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, controlled trial of BCG (Tokyo 172) vaccine single dose given intradermally compared to placebo vaccine (diluent) given intradermally single dose
| Arm | Type | Receives |
|---|---|---|
| BCG vaccine | Experimental | Biological: BCG (Tokyo 172) vaccineFreeze-dried Glutamate Bacillus Calmette-Guérin (BCG) (Tokyo 172) vaccine |
| Placebo | Placebo comparator | Drug: PlaceboVaccine diluent [sodium glutamate] |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Participants will be eligible for study participation if they meet all of the following criteria:
Key exclusion criteria (20 listed)
- Participants will be ineligible for study participation if they meet any of the following criteria:
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 (Tokyo 172) vaccineFreeze-Dried Glutamate Bacillus Calmette-Guérin BCG Vaccine (Japan BCG Laboratory), 0.1 mL given as single dose by intradermal injection over the outer lower aspect of the deltoid region | Biological | BCG vaccine |
| PlaceboAlso: sodium glutamatePlacebo vaccine diluent, 0.1 mL given as single dose by intradermal injection over the outer lower aspect of the deltoid region | Drug | Placebo |
Primary outcome
Change in TB IGRA blood test results from baseline pre-travel and post-travel return
Time frame: At baseline, and 8-10 weeks post-travel return
Conversion change of TB IGRA from pre-travel baseline value of negative to positive post-travel, using FDA-approved breakpoints as a measure of Mycobacterium tuberculosis infection. Response will be assessed using technology of the T-SPOT.TB test method. Specifically, the test measures the number of spots from T cells sensitized to TB infection on a plate containing 4 different antigens: nil (negative control), 2 TB antigens (ESAT-6 and CFP-10, also called Panel A and Panel B), and phytohemagglutinin (positive control). Results are interpreted by subtracting the spot count in the negative (NIL) control from the spot count in Panels A and B: * Positive ≥ 8 spots * Negative ≤ 4 spots (this includes values less than zero) * Borderline 5, 6, or 7 spots * Invalid
5 secondary outcomes
Number of Participants with sustained conversion and reversion in the TB IGRA converters
Time frame: 4-6 months from return post-travel
Number of Participants with history of TB disease/symptoms while deployed
Time frame: Through final IGRA testing, expected average time 8-10 weeks post-travel return
Identify potential risk factors for Mtb infection in the targeted study population collected on Post-Travel Questionnaire
Time frame: Through final IGRA testing, expected average time 8-10 weeks post-travel return
Number of Participants with treatment-related adverse effects following intradermal administration of BCG vaccine
Time frame: Baseline (pre-administration of vaccine), within 30 minutes of vaccination, 14-days post-vaccination, and 2 to 6 weeks post-vaccination (Visit 3)
Number of Participants with self-reported symptoms of all-cause respiratory infections acquired while traveling abroad
Time frame: Through final IGRA testing, expected average time 8-10 weeks post-travel return
Results and safety
The study was stopped early (reason given: The sponsor has elected to discontinue/terminate the study prematurely due to slower-than-anticipated recruitment and limited remaining research funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Naomi E. Aronson, MD study chair
Uniformed Services University of the Health Sciences
Merlin L. Robb, MD study director
Henry M. Jackson Foundation for the Advancement of Military Medicine
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BCG (Tokyo 172) vaccine in people with Tuberculosis Infection, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 7 sites in United States.
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 20 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: stopped early, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 stopped early (reason given: The sponsor has elected to discontinue/terminate the study prematurely due to slower-than-anticipated recruitment and limited remaining research funding.). Results are not available in the source record.
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?
Change in TB IGRA blood test results from baseline pre-travel and post-travel return (time frame: At baseline, and 8-10 weeks post-travel return). 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 23 Jan 2026.