Tuberculosis Clinical Trial
Official title:
Evaluation of the Heterologous Effects of Bacille Calmette-Guérin (BCG) Vaccination in Healthy UK Adults
Verified date | October 2016 |
Source | University of Oxford |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: Research Ethics Committee |
Study type | Interventional |
TB038 is a clinical study to assess the non-specific effects of BCG vaccination and gain a better understanding of how the body's immune system reacts to BCG and in turn potentially prevents infection from other bacteria.
Status | Completed |
Enrollment | 36 |
Est. completion date | November 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: Volunteers must meet all of the following criteria to enter the study: - Healthy adult aged 18-45 years - BCG naïve - Resident in or near Oxford (for CCTVM and John Warin Ward) or Birmingham (for NIHR 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 and for a period of 3 months after their last visit - Give written informed consent - Allow the Investigator to register volunteer details with a confidential database to prevent concurrent entry into clinical trials or studies - 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 IGRA response - 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 - Concurrent use of long term antibiotic therapy - History of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the BCG vaccine - 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 study or 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 vaccine - 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: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United Kingdom | NIHR 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 |
United Kingdom | Oxford University Hospitals- John Warin Ward, University of Oxford | Oxford | Oxfordshire |
Lead Sponsor | Collaborator |
---|---|
University of Oxford |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Background levels of S. aureus, K. pneumonia, Group B streptococci and E.coli carriage. | Use of bacterial antibody titres, nasal swab culture and faecal culture to determine background levels of S. aureus, K. pneumonia, Group B streptococci and E.coli carriage in subjects in this study. | Up to Day 14 | No |
Other | Confounding effects of BCG on bacterial growth. | Use of bacterial antibody titres, nasal swab culture and faecal culture to evaluate confounding effects of BCG on the growth of S. aureus, K. pneumonia, Group B streptococci and E.coli. | Up tp Day 14 | No |
Primary | Growth inhibition assays | Determine the heterologous effects of BCG vaccination in healthy UK adults using in-vitro Growth Inhibition Assays as a surrogate marker to assess the individuals' capacity to control growth of S. aureus, K. pneumonia, Group B streptococci and E.coli. | Up to Day 84 | No |
Secondary | Immune response markers | Evaluation of laboratory markers of the immune response that correlate with levels of bacterial growth inhibition identified using the in-vitro GIAs. | Up to Day 84 | No |
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