Immunization With BCG Vaccine to Prevent Tuberculosis Infection

Launched by HENRY M. JACKSON FOUNDATION FOR THE ADVANCEMENT OF MILITARY MEDICINE · Jun 26, 2020

Keywords

ClinConnect Summary

This clinical trial is studying whether a single dose of the BCG vaccine can help prevent tuberculosis (TB) infection in adults who are traveling to countries where TB is common. Researchers want to see if this vaccine can boost the immune system to fight off TB. Participants in the study will be randomly assigned to receive either the BCG vaccine or a placebo (an inactive substance that looks like the vaccine). The trial is open to 2,000 volunteers aged 18 to 65 who are in good health and have no history of TB infection or previous BCG vaccination. It is especially looking for people who are planning to travel to high TB risk areas for at least 4 weeks.

If you decide to join the study, you'll need to give your consent and undergo some health screenings. You'll receive the vaccine or placebo at least four weeks before your travel, and you'll be asked to attend follow-up visits. It's important to note that the BCG vaccine is not approved for use in the United States, so participating in this trial means you are part of an experimental study. Additionally, there are some criteria that could exclude you from participation, such as having a weakened immune system or being pregnant. If you think you meet the eligibility requirements and are interested, this trial could be an opportunity to help researchers learn more about preventing TB.

Gender

ALL

Eligibility criteria

• Inclusion 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
• For Females of Childbearing Potential Only:
• • 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
• Exclusion Criteria:
• * 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