ISRCTN17498868
Completed
Phase 1
A phase I study evaluating the safety and immunogenicity of a new TB vaccine MVA85A, in healthy volunteers with no evidence of infection with mycobacterium tuberculosis, in Cape Town
niversity of Oxford (UK)0 sites36 target enrollmentJanuary 25, 2008
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity of Oxford (UK)
- Enrollment
- 36
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Healthy adults aged 18 to 50 years (for the first 2 arms), either sex
- •2\. Healthy adolescents (aged 12 \- 14\) for the third arm of the study, either sex
- •3\. Screening Elispot negative (less than 17 spots/million PBMC) in all three ESAT6 pools and all three CFP10 pools
- •4\. Mantoux test less than 15 mm (less than 10 mm if BCG negative)
- •5\. Chest x\-ray (CXR) normal with no evidence of active or past TB
- •6\. For females only, willingness to practice continuous effective contraception during the study and a negative pregnancy test on the day of vaccination
- •7\. Agreement to refrain from blood donation during the course of the study
- •8\. Written informed consent
- •9\. Willingness to undergo a human immunodeficiency virus (HIV) test
Exclusion Criteria
- •1\. Any deviation from the normal range in biochemistry or haematology blood tests or in urine analysis
- •2\. Mantoux greater than 15 mm
- •3\. Prior receipt of a recombinant MVA or Fowlpox vaccine
- •4\. 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
- •5\. 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).
- •6\. Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection and asplenia
- •7\. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products
- •8\. Evidence of cardiovascular disease
- •9\. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
- •10\. History of diabetes mellitus
Outcomes
Primary Outcomes
Not specified
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