Immunization With BCG Vaccine to Prevent Tuberculosis Infection

• Status: Not yet recruiting
• Trial end date: 2024-05-14
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Collaborators: Uniformed Services University of the Health Sciences; United States Department of Defense

Criteria

Inclusion Criteria:

• Subjects will be eligible for study participation if they meet all of the following criteria:

1. Subject 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. Subject is male or female, age ≥ 18 years and ≤ 65 years at time of consent

3. Subject is in good general health, confirmed by medical history, laboratory screening, and physical examination

4. Subject has no known history of Mtb infection

5. Subject has no prior history of BCG vaccination, or previous receipt of an investigational Mtb vaccine

6. Subject 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. Subject presents at least 4 weeks prior to travel departure

8. Subject is willing to forego any periodic tuberculin skin test screening procedures for 6 months after receiving BCG/placebo vaccine

9. Subject is willing to complete all study visits as required by the protocol and is reachable by telephone or email during the study

10. Subject agrees to medical record access for purposes of relevant medical history collection

For Females of Childbearing Potential Only:

11. Subject has a negative urine pregnancy test prior to starting study treatment

12. Subject is willing to use effective contraception for at least 30 days before and 6 weeks after BCG/placebo vaccination

13. Lactating female that is willing to refrain from breast-feeding for 6 weeks post-vaccination

Exclusion Criteria:

• Subjects will be ineligible for study participation if they meet any of the following criteria:

1. Subject has known positive tuberculin skin test (>10 mm) or positive IGRA

2. Subject has medical condition for which BCG vaccination is contraindicated (e.g., HIV or other immunocompromised conditions)

3. Subject is currently receiving (within last 30 days) immune-compromising treatments, such as TNF-α blockade

4. Subject has history of chronic (≥ 30 days) oral steroid use or intravenous (IV) steroids within the last 90 days

5. Subject has received radiation therapy or chemotherapy within the last 180 days

6. Subject has received BCG treatment for bladder cancer

7. Subject 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. Subject is unwilling to complete all required study elements (e.g., HIV testing)

9. Subject 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. Subject has known or suspected hypersensitivity to BCG vaccine or related products