Tuberculosis Clinical Trial
Official title:
A Human Pilot Study to Quantify BCG From the BCG Vaccination Site, and to More Fully Characterise the Immune Response to BCG
Verified date | June 2010 |
Source | University of Oxford |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: Research Ethics Committee |
Study type | Interventional |
This is a human pilot study of 16 healthy BCG-naïve volunteers to quantify BCG from the BCG vaccination site. Volunteers will be vaccinated with BCG. The first 8 will go on to have a punch biopsy and suction blister of the vaccination sites at 2 weeks post vaccination (arm A) the second 8 will have a biopsy and blister at 1 or 4 weeks post-vaccination (arm B). Methods of mycobacterial quantification on these tissue samples will then be compared
Status | Completed |
Enrollment | 40 |
Est. completion date | April 2010 |
Est. primary completion date | April 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Subject is willing and able to give informed consent for participation in the study - Male or Female, aged 18 to 50 years - In good health - BCG-naïve - Screening elispot negative (less than 17 spot forming cells per million PBMC) for ESAT 6 and CFP 10 peptide pools - Resident in or near Oxford for the duration of the study - Female patient/subjects of child bearing potential must be willing to ensure that they practice effective contraception use during the study. - Subject has clinically acceptable laboratory results from Pre Study Screen - Able (in the Investigators opinion) and willing to comply with all study requirements - Willing to allow his or her General Practitioner to be notified of participation in the study Exclusion Criteria: - Previous BCG vaccination - Female subject who is pregnant, lactating or planning pregnancy during the course of the study - Persons suffering from malignant conditions (e.g., lymphoma, leukaemia, Hodgkin's disease or other tumours of the reticulo-endothelial system), primary or secondary immunodeficiencies, HIV infection, or moderate/severe dermatological conditions - Administration of chronic (defined as more than 14 days) immunosuppressive drugs or other immune modifying drugs within six months of vaccination. (For corticosteroids, this will mean prednisolone, or equivalent, = 0.5 mg/kg/day. Inhaled and topical steroids are allowed) - Any history of severe allergic reaction or anaphylaxis in reaction to vaccination - Administration of immunoglobulins or donation of blood products during the study or within the past 12 weeks - Suspected or known current drug and/or alcohol abuse (as defined by an alcohol intake of >42 units a week) - Any on-going chronic illness requiring hospital specialist supervision - Any other significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or may influence the result of the study, or the subject's ability to participate in the study. - Subjects who have participated in another research study involving an investigational product in the past 12 weeks |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United Kingdom | CCVTM, University of Oxford | Oxford |
Lead Sponsor | Collaborator |
---|---|
University of Oxford |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quantification of BCG after BCG vaccination | 2 or 4 weeks | No | |
Secondary | Immunogenicity of BCG vaccination | 2 or 4 weeks | No |
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