Tuberculosis Clinical Trial
Official title:
A Clinical Challenge Study to Quantify BCG at the Challenge Site of Healthy Volunteers Receiving Either Intradermal BCG SSI or BCG TICE at Standard or High Dose
TB031 is a challenge study comparing two different strains of the Bacille Calmette-Guérin (BCG) vaccine at standard and high dose.
Status | Completed |
Enrollment | 52 |
Est. completion date | January 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: Volunteers must meet all of the following criteria to enter the study: - Healthy adult aged 18-55 years - BCG naïve - Resident in or near Oxford (for CCTVM) or Birmingham (for WTCRF) for the duration of the study period - No relevant findings in medical history or on physical examination - Allow the Investigators to discuss the volunteer's medical history with their GP - Use effective contraception for the duration of the study period (females only) - Agreement to refrain from blood donation during the duration of the study - Give written informed consent - Allow the Investigator to register volunteer details with a confidential database to prevent concurrent entry into clinical trials - Able and willing (in the Investigator's opinion) to comply with all the study requirements Exclusion Criteria: Volunteers must meet none of the following criteria to enter the study: - Laboratory evidence at screening of latent M. tb infection as indicated by a positive ELISPOT response to ESAT6 or CFP10 antigens - Clinical, radiological, or laboratory evidence of current active TB disease - Previous vaccination with BCG, or any candidate TB vaccine - Within the last year had close household contact with an individual with smear positive pulmonary tuberculosis - Clinically significant history of skin disorder, allergy, immunodeficiency (including HIV), cancer (except BCC or CIS), cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, neurological illness, psychiatric disorder, drug or alcohol abuse - History of serious psychiatric condition - Concurrent oral or systemic steroid medication or the concurrent use of other immunosuppressive agents - History of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the challenge agent - 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 - Positive HBsAg, HCV or HIV antibodies - Female confirmed pregnant or intention to become pregnant during study period, or currently lactating - Current involvement in another trial that involves regular blood tests or an investigational medicinal product - Use of an investigational medicinal product or non-registered drug, live vaccine, or investigational medical device for four weeks prior to dosing with the study challenge agent - Administration of immunoglobulins and/or any blood products within the three months preceding the planned challenge date - Any other significant disease, disorder, or finding, which, in the opinion of the Investigator, may either put the volunteer at risk, or may influence the result of the study, or may affect the volunteer's ability to participate in the study |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United Kingdom | The Wellcome Trust Clinical Research Facility, University of Birmingham | Birmingham | West Midlands |
United Kingdom | Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford | Oxford | Oxfordshire |
Lead Sponsor | Collaborator |
---|---|
University of Oxford | Aeras, University of Birmingham |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Local and systemic adverse events | To evaluate and compare local and systemic adverse events between the different challenge models through actively and passively collected data on adverse events. | Up to Day 28 | Yes |
Other | Mycobacterial Growth Inhibition Assays | Use of Mycobacterial Growth Inhibition Assays to evaluate the effect of recent BCG vaccination on in-vitro ability to control Staphylococcus aureus, and potentially also Klebsiella, Group B streptococcus and Escherichia coli. | Up to day 14 | No |
Primary | Quantity of BCG at challenge site | To evaluate and compare the amount of BCG (measured by CFU count and PCR) from a biopsy taken from the intradermal BCG challenge site in healthy BCG-naïve adults receiving either BCG SSI or BCG Tice at either standard or high dose | At Day 14 | No |
Secondary | Immune response markers | To identify laboratory markers of the immune response that correlate with the levels of mycobacterial suppression at the BCG challenge site | Up to Day 14 | No |
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