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 Previously Received BCG
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|ClinicalTrials.gov Identifier: NCT00427830|
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|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||16 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 Previously Received BCG|
|Study Start Date :||May 2003|
|Study Completion Date :||January 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 immunisation (and after 7 days).
- 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 on strong CD4+ and CD8+ responses respectively.
- Antibody titres will be measured from frozen plasma samples.
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): NCT00427830
|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|