sing the BCG vaccine to understand tuberculosis infectio

Not Applicable

• Conditions: The use of a human challenge model for tuberculosis using BCG, which could be used to test vaccines and therapeutics; Infections and Infestations

• Registration Number: ISRCTN94098600
• Lead Sponsor: iverpool School of Tropical Medicine

Brief Summary

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39219857/ (added 02/09/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-29
• Last Update Posted: 9 September 2024
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Healthy adults aged 18-50 years (inclusive)
2. Resident near Liverpool School of Tropical Medicine (LSTM) (<1 h drive) for the duration of the study period
3. Allows the investigators to discuss the volunteer’s medical history with their GP
4. Females of childbearing potential with a negative urine pregnancy test at screening and willing to practice adequate birth control measures during the study.
5. Fluent spoken English - to ensure a comprehensive understanding of the research project and their proposed involvement
6. Capacity to provide written informed consent
7. Able and willing (in the investigator's opinion) to comply with all the study requirements

Exclusion Criteria

1. Laboratory evidence at screening of latent M. tb infection as indicated by a positive ELISPOT response to ESAT6 or CFP10 antigens
2. Clinical, radiological, or laboratory evidence of current active TB disease
3. Previous vaccination with BCG, or any candidate TB vaccine
4. Within the last year had close household contact with an individual with smear-positive pulmonary tuberculosis
5. Clinically significant history of skin disorder, allergy, immunodeficiency (including HIV), cancer, cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, neurological illness or psychiatric disorder
6. Current medical issues:
6.1. Acute respiratory tract infection in the 4 weeks preceding recruitment
6.2. Any uncontrolled medical or surgical condition at the discretion of the study doctor
7. Maternal:
7.1. Female participants who are pregnant
7.2. Female participants who are lactating
7.3. Female participants who intend to become pregnant during the study
7.4. Female participants who are unable to take contraception measures during the study
8. Smoking:
8.1. Current (defined as =5/week) or ex-smoker (cigarettes/cigars/e-cigarette /vaping/smoking of recreational drugs) in the last 6 months
8.2. Previous significant smoking history (more than 20 cigarettes per day for 20 years or the equivalent [>20 pack years])
9. Current alcohol and recreational drug use
9.1. Regularly drinks =3 units/day (male) or =2 units/day (female)
9.2. Uses recreational drugs
9.3. Participants may be excluded at the discretion of the research clinician
10. Concurrent oral or systemic steroid medication or the concurrent use of other immunosuppressive agents
11. History of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the challenge agent
12. Has received any vaccination within one month of the screening visit
13. Has not completed at least two COVID-19 vaccination doses
14. Any abnormality of screening blood or urine tests that is deemed to be clinically significant or that may compromise the safety of the volunteer in the study
15. Positive HBsAg, HCV or HIV antibodies
16. Current involvement in another trial that involves regular blood tests or an investigational medicinal product
17. Use of an investigational medicinal product or non-registered drug, live vaccine, or investigational medical device for 4 weeks prior to dosing with the study challenge agent
18. Administration of immunoglobulins and/or any blood products within the three months preceding the planned challenge date
19. Participants who meet STOP criteria at the time of screening
20. Any other issue which, in the opinion of the study staff, may:
20.1. Put the participant or their contacts at risk because of participation in the study
20.2. Adversely affect the interpretation of the study results
20.3. Impair the participant’s ability to participate in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified