Safety and Immunogenicity of MVA85A in Volunteers Latently Infected With TB.
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|ClinicalTrials.gov Identifier: NCT00456183|
Recruitment Status : Completed
First Posted : April 4, 2007
Last Update Posted : May 31, 2007
|Condition or disease||Intervention/treatment||Phase|
|Tuberculosis||Biological: MVA 85A||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study Evaluating the Safety and Immunogenicity of a New TB Vaccine, MVA85A, in Healthy Volunteers Who Are Latently Infected With Mycobacterium Tuberculosis.|
|Study Start Date :||August 2005|
|Actual Study Completion Date :||April 2007|
- Safety of a single intradermal injection of 5 x 107pfu MVA85A [ Time Frame: One year ]
- Efficacy [ Time Frame: One year ]
- latently infected with MVA85A on the immune response, both to antigen 85A (the antigen in
- the vaccine) and to ESAT6/CFP10 antigens (M.tb specific).
- The specific endpoints for safety and reactogenicity will be actively and passively collected
- data on adverse events (AEs). The specific endpoints for immunogenicity will be markers of
- cell-mediated immunity as described below.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00456183
|Centre for Clinical Vaccinology and Tropical Medicine|
|Oxford, Oxfordshire, United Kingdom, OX3 7LJ|
|Principal Investigator:||Helen McShane||University of Oxford|