A Phase I Study of the Safety and Immunogenicity of a Recombinant MVA Vaccine Encoding a Secreted Antigen From M. Tuberculosis, Antigen 85A, Delivered Intradermally by a Needle Injection in Healthy Volunteers Who Have Received BCG Immunisation 1 Month Previously
|ClinicalTrials.gov Identifier: NCT00427453|
Recruitment Status : Completed
First Posted : January 29, 2007
Last Update Posted : January 29, 2007
|Condition or disease||Intervention/treatment||Phase|
|Tuberculosis||Biological: MVA85A||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of the Safety and Immunogenicity of a Recombinant MVA Vaccine Encoding a Secreted Antigen From M. Tuberculosis, Antigen 85A, Delivered Intradermally by a Needle Injection in Healthy Volunteers Who Have Received BCG Immunisation 1 Month Previously|
|Study Start Date :||June 2003|
|Study Completion Date :||March 2005|
- The occurance and severity of local and systemic side effects will be monitored. Vital signs and local reactions will be monitored at 30 and 60 minutes after each mmunisation (and after 7 days).
- Blood will be taken at: the screening visit, prior to the BCG vaccination, 1 and 4 weeks after the BCG vaccination, and also at 1,4, 8, 12 and 24 weeks after the MVA85A vaccination.
- Immunogenicity will be measured: The induction of T cell responses (as measured by an interferon-gamma Elispot assay) will be performed on PBMCs from blood samples taken at the specified time points.
- Proliferation assays and cytotoxic T cell assays will be performed. Other serological measures of immune response, i.e. antibody titres will be analysed on frozen plasma samples.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00427453
|Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford, Churchill Hospital|
|Oxford, Oxfordshire, United Kingdom, OX3 7LJ|
|Principal Investigator:||Helen McShane, MD and PhD||University of Oxford|