Tuberculosis Clinical Trial
Official title:
A Phase I Study to Assess the Safety and Immunogenicity of New TB Vaccine Candidates FP85A and MVA85A, in Healthy Adults Who Have Previously Been Immunized With BCG, Using a Prime-boost Delivery Schedule
Verified date | February 2010 |
Source | University of Oxford |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: Department of Health |
Study type | Interventional |
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 healthy volunteers, who have previously been vaccinated with BCG. The secondary outcome is to assess the cellular immune response in the same population. The trial consists of 36 subjects in 3 groups. The first group will be vaccinated with FP85A alone, the second group will be vaccinated with MVA85A followed by FP85A 28 days later and the third group will be vaccinated with FP85A followed by MVA85A 28 days later.
Status | Completed |
Enrollment | 31 |
Est. completion date | January 2010 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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 | To assess the safety of a new tuberculosis vaccine, FP85A, when administered individually and sequentially with MVA85A in a prime-boost regime, to healthy volunteers, who have previously been vaccinated with BCG | 3 months | Yes | |
Secondary | To assess the cellular immune response generated by FP85A, when administered individually and sequentially with MVA85A in a prime-boost regime to healthy volunteers, who have previously been vaccinated with BCG. | 12 months | No |
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