Status:
COMPLETED
A Phase I Study to Assess the Safety and Immunogenicity of Tuberculosis (TB) Vaccine Candidates FP85A and MVA85A
Lead Sponsor:
University of Oxford
Conditions:
Tuberculosis
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
This is a Phase I study whose primary outcome is to assess the safety of a new tuberculosis vaccine, FP85A, when administered individually and sequentially with MVA85A in a prime-boost regime, to heal...
Detailed Description
Recombinant fowlpox virus as a vector Fowlpox virus is only infectious to avian species, but it is able to express antigens in mammalian cells and induce protective immune responses, making it a suit...
Eligibility Criteria
Inclusion
- Healthy adult aged 18 to 50 years
- Resident in or near Oxford for the duration of the vaccination study
- Immunization with BCG greater than 12 months prior to enrolment in the study
- Able and willing (in the Investigators' opinions) to comply with all study requirements
- Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner
- Agreement to practice barrier contraception from the start of the study until 3 months after the final vaccination
- For females, a negative pregnancy test on the day of vaccination and agreement to practice effective contraception for the entire duration of the study
- Agreement to refrain from blood donation during the course of the study
- Written informed consent
Exclusion
- Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period
- Prior receipt of a recombinant MVA or fowlpox vaccine
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
- Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products
- Any history of anaphylaxis in reaction to vaccination
- Close contact with fowl during the study period (e.g. chicken farming)
- History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
- History of serious psychiatric condition
- Any other chronic illness requiring hospital specialist supervision
- Suspected or known current injecting drug or alcohol abuse (as defined by an alcohol intake of greater than 42 units every week)
- Seropositive for hepatitis B surface antigen (HBsAg)
- Seropositive for hepatitis C virus (antibodies to HCV)
- For females, pregnancy, lactation or willingness/intention to become pregnant during the study
- Any other significant disease, disorder or finding, which, in the opinion of the Investigators, may either put the volunteer at risk because of participation in the study, or may influence the result of the study, or the volunteer's ability to participate in the study.
- Mantoux skin test equal to or greater than 15 millimetres
- Screening Elispot positive (greater than 17 sfc/million PBMC) in any ESAT6 peptide or CFP10 peptide pool
- Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00653770
Start Date
September 1 2007
End Date
January 1 2010
Last Update
February 9 2010
Active Locations (1)
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1
CCVTM, University of Oxford
Oxford, United Kingdom, OX3 7LJ