RECRUITING

Immunization With BCG Vaccine to Prevent Tuberculosis Infection

Conditions

Tuberculosis Infection BCG Vaccine Tuberculosis vaccine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 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.

Official Title

A Proof-of Concept, Randomized, Controlled Study of Tuberculosis Immunization With BCG to Prevent Infection in Healthy Adults (TIPI Trial)

Quick Facts

Study Start:2021-12-01

Study Completion:2027-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04453293

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Participants will be eligible for study participation if they meet all of the following criteria: 1. 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 2. Participant is male or female, age ≥ 18 years and ≤ 65 years at time of consent 3. Participant is in good general health, confirmed by medical history, laboratory screening, and physical examination 4. Participant has no known history of Mtb infection 5. Participant has no prior history of BCG vaccination, or previous receipt of an investigational Mtb vaccine 6. Participant is assessed to be at risk for TB exposure (particularly drug resistant TB) during planned travel and has planned to work in high TB burden countries for a duration of \>4 weeks and \<6 months for HCW, or ≥6 months and ≤2.5 years if long term traveler and/or/HCW 7. Participant presents at least 4 weeks prior to travel departure 8. Participant is willing to forego any periodic tuberculin skin test screening procedures for 6 months after receiving BCG/placebo vaccine 9. Participant is willing to wait after receiving a COVID-19 vaccine for 7 days before receiving BCG/placebo vaccine 10. Participant is willing to complete all study visits as required by the protocol and is reachable by telephone or email during the study 11. Participant agrees to medical record access for purposes of relevant medical history collection 12. Participant has a negative urine pregnancy test prior to starting study treatment 13. Participant is willing to use effective contraception for at least 30 days before and 6 weeks after BCG/placebo vaccination 14. Lactating female that is willing to refrain from breast-feeding for 6 weeks post-vaccination	* Participants will be ineligible for study participation if they meet any of the following criteria: 1. Participant has known positive tuberculin skin test (\>10 mm) or positive IGRA 2. Participant has medical condition for which BCG vaccination is contraindicated (e.g., HIV or other immunocompromised conditions) 3. Participant is currently receiving (within last 30 days) immune-compromising treatments, such as TNF-α blockade 4. Participant has history of chronic (≥ 30 days) oral steroid use or intravenous (IV) steroids within the last 90 days 5. Participant has received radiation therapy or chemotherapy within the last 180 days 6. Participant has received BCG treatment for bladder cancer 7. 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 8. Participant is unwilling to complete all required study elements (e.g., HIV testing) 9. 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) 10. Participant has known or suspected hypersensitivity to BCG vaccine or related products 11. Participant has positive/borderline IGRA test at screening 12. Participant has positive/indeterminate HIV test at screening unless has received prior HIV vaccine 13. Participant has a history of life-threatening adverse event following receipt of any immunization 14. 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 15. 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 16. Participant has had tuberculin skin testing performed within 1 month prior to Visit 1 17. Participant has received a COVID-19 vaccine within 7 days prior to BCG/placebo vaccine 18. 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 19. Participant has prior history of nontuberculous mycobacterial disease, not colonization only

Inclusion Criteria

Exclusion Criteria

* Participants will be eligible for study participation if they meet all of the following criteria:
1. 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
2. Participant is male or female, age ≥ 18 years and ≤ 65 years at time of consent
3. Participant is in good general health, confirmed by medical history, laboratory screening, and physical examination
4. Participant has no known history of Mtb infection
5. Participant has no prior history of BCG vaccination, or previous receipt of an investigational Mtb vaccine
6. Participant is assessed to be at risk for TB exposure (particularly drug resistant TB) during planned travel and has planned to work in high TB burden countries for a duration of \>4 weeks and \<6 months for HCW, or ≥6 months and ≤2.5 years if long term traveler and/or/HCW
7. Participant presents at least 4 weeks prior to travel departure
8. Participant is willing to forego any periodic tuberculin skin test screening procedures for 6 months after receiving BCG/placebo vaccine
9. Participant is willing to wait after receiving a COVID-19 vaccine for 7 days before receiving BCG/placebo vaccine
10. Participant is willing to complete all study visits as required by the protocol and is reachable by telephone or email during the study
11. Participant agrees to medical record access for purposes of relevant medical history collection
12. Participant has a negative urine pregnancy test prior to starting study treatment
13. Participant is willing to use effective contraception for at least 30 days before and 6 weeks after BCG/placebo vaccination
14. Lactating female that is willing to refrain from breast-feeding for 6 weeks post-vaccination

* Participants will be ineligible for study participation if they meet any of the following criteria:
1. Participant has known positive tuberculin skin test (\>10 mm) or positive IGRA
2. Participant has medical condition for which BCG vaccination is contraindicated (e.g., HIV or other immunocompromised conditions)
3. Participant is currently receiving (within last 30 days) immune-compromising treatments, such as TNF-α blockade
4. Participant has history of chronic (≥ 30 days) oral steroid use or intravenous (IV) steroids within the last 90 days
5. Participant has received radiation therapy or chemotherapy within the last 180 days
6. Participant has received BCG treatment for bladder cancer
7. 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
8. Participant is unwilling to complete all required study elements (e.g., HIV testing)
9. 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)
10. Participant has known or suspected hypersensitivity to BCG vaccine or related products
11. Participant has positive/borderline IGRA test at screening
12. Participant has positive/indeterminate HIV test at screening unless has received prior HIV vaccine
13. Participant has a history of life-threatening adverse event following receipt of any immunization
14. 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
15. 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
16. Participant has had tuberculin skin testing performed within 1 month prior to Visit 1
17. Participant has received a COVID-19 vaccine within 7 days prior to BCG/placebo vaccine
18. 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
19. Participant has prior history of nontuberculous mycobacterial disease, not colonization only

Contacts and Locations

Study Contact

Kelly A. Hummer, RN, BSN

CONTACT

703-408-6273

kelly.hummer.ctr@usuhs.edu

Marianne Spevak

CONTACT

240-694-2067

mspevak@hjf.org

Principal Investigator

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

Study Locations (Sites)

Yale University School of Medicine

New Haven, Connecticut, 06510

United States

MedStar Washington Hospital Center/MedStar Health Research Institute

Washington, District of Columbia, 20010

United States

Hope Clinic of the Emory University Vaccine Center, Emory University

Decatur, Georgia, 30030

United States

The Brigham and Women's Hospital Center for Clinical Investigation

Boston, Massachusetts, 02115

United States

Baylor College of Medicine

Houston, Texas, 77030

United States

University of Utah School of Medicine

Salt Lake City, Utah, 84108

United States

Collaborators and Investigators

Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-01

Study Completion Date2027-09-30

Study Record Updates

Study Start Date2021-12-01

Study Completion Date2027-09-30

Terms related to this study

Keywords Provided by Researchers

BCG Vaccine
Tuberculosis vaccine

Additional Relevant MeSH Terms

Tuberculosis Infection