Safety and Immunogenicity of MVA85A in Volunteers Latently Infected With TB.
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 intradermally, is safe in both mycobacterially naïve individuals and those previously vaccinated with BCG. We will use the same vaccination regime in this study. Subjects will be defined as being latently infected if they have a positive elispot response to ESAT6 or CFP10. Subjects will be identified from TB contact clinics.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|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.|
- 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.
|Study Start Date:||August 2005|
|Study Completion Date:||April 2007|
|Centre for Clinical Vaccinology and Tropical Medicine|
|Oxford, Oxfordshire, United Kingdom, OX3 7LJ|
|Principal Investigator:||Helen McShane||University of Oxford|