Status:
COMPLETED
A BCG Challenge Model Study to Assess Anti-mycobacterial Immunity Induced by BCG and a Candidate TB Vaccine, MVA85A
Lead Sponsor:
University of Oxford
Conditions:
Tuberculosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the BCG 'challenge' model a four-arm study design has been chosen. Twelve subjects will be recruited into each arm of the study. Allocation of BCG-naïve volunt...
Eligibility Criteria
Inclusion
- Healthy adult aged 18-55 years
- Resident in or near Oxford for the duration of the study period
- No relevant findings in medical history or on physical examination
- Willingness to allow the Investigators to discuss the individual's medical history with their GP
- Willingness to use effective contraception for the duration of the study period (females only)
- Agreement to refrain from blood donation during the course of the study
- Willingness to give written informed consent
- Agreement to 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
- Additional criteria to be met for subjects in group A:
- None
- Additional criteria to be met for subjects in group B:
- Willingness to use continuous effective barrier contraception for three months after receiving
- MVA85A vaccination (males and females)
- Additional criteria to be met for subjects in group C:
- Confirmation of prior vaccination with BCG not less than three months prior to projected study enrolment date (by visible BCG scar on examination or written documentation)
- Additional criteria to be met for subjects in group D:
- Confirmation of prior vaccination with BCG not less than three months prior to projected study enrolment date (by visible BCG scar on examination or written documentation)
- Willingness to use continuous effective barrier contraception for three months after receiving MVA85A vaccination (males and females)
Exclusion
- Clinical, radiological, or laboratory evidence of current active TB disease
- Laboratory evidence at screening of latent M. tb infection as indicated by a positive ELISPOT test (\>17 sfc/million PBMC) in any ESAT6 peptide or CFP10 peptide poola
- Previous vaccination with candidate TB vaccine MVA85A or candidate TB vaccine FP85A
- 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 study 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 studyb
- Positive HBsAg, HCV or HIV antibodies
- Female currently lactating, confirmed pregnancy or intention to become pregnant during study period
- Use of an investigational medicinal product or non-registered drug, live vaccine, or medical device other than the study vaccine for 60 days prior to dosing with the study vaccine, or planned use during the study period
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned trial vaccination 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
- Additional exclusion criteria for subjects in group A:
- Previous vaccination with BCG
- Additional exclusion criteria for subjects in group B:
- Previous vaccination with a recombinant MVA vaccine other than MVA85A or FP85A
- Previous vaccination with BCG
- Additional exclusion criteria for subjects in group C:
- None
- Additional exclusion criteria for subjects in group D:
- Previous vaccination with a recombinant MVA vaccine other than MVA85A or FP85A
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01194180
Start Date
May 1 2010
End Date
January 1 2012
Last Update
August 30 2012
Active Locations (1)
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1
Centre for Clinical Vaccinology and Tropical Medicine
Oxford, Oxon, United Kingdom, OX3 7LJ