Status:
COMPLETED
Safety and Immunogenicity of MVA85A in Volunteers Latently Infected With TB.
Lead Sponsor:
University of Oxford
Conditions:
Tuberculosis
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
This study is designed to evaluate the safety of MVA85A in healthy volunteers in the UK who are latently infected with M.tb. A single vaccination with MVA85A, when administeredat a dose of 5 x 107pfu ...
Detailed Description
Tuberculosis (TB) kills about three million people annually. It is estimated that one third of the world's population are latently infected with Mycobacterium tuberculosis (M.tb) (Dye, 1999). These la...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Healthy adults aged 18 to 50 years
- Resident in or near Oxford for the duration of the vaccination study
- Willingness to allow the investigators to discuss the volunteer's medical history with the volunteer's GP
- Screening Elispot positive (more than 50 spots/million PBMC) for at least any 1 of the 3 ESAT6 peptide pools or any one of the 3 CFP10 pools ; and screening Elispot positive for PPD.
- Heaf test grade II-IV or positive Mantoux test.
- CXR normal; or abnormal but not clinically significant CXR findings with no evidence of past/present TB infection or disease on the CXR.
- For females only, willingness to practice continuous effective contraception during the study and a negative pregnancy test on the day of vaccination
- Agreement to refrain from blood donation during the course of the study
- Written informed consent
- Willingness to undergo an HIV
- Exclusion Criteria
- Any deviation from the normal range in biochemistry or haematology blood tests or in urine analysis
- Heaf grade IV
- Prior receipt of a recombinant MVA or Fowlpox vaccine
- Use of any investigational or non-registered drug, live vaccine or medical device other than the study vaccine within 30 days preceding dosing of study vaccine, or planned use during the study period
- 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, ε 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection and asplenia
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products
- Evidence of cardiovascular disease
- History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
- History of insulin requiring diabetes mellitus
- Chronic or active neurological disease requiring ongoing specialist supervision
Exclusion
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00456183
Start Date
August 1 2005
End Date
April 1 2007
Last Update
May 31 2007
Active Locations (1)
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1
Centre for Clinical Vaccinology and Tropical Medicine
Oxford, Oxfordshire, United Kingdom, OX3 7LJ