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| Sponsored by: |
University of Oxford |
|---|---|
| Information provided by: | University of Oxford |
| ClinicalTrials.gov Identifier: | NCT00423566 |
Purpose
This study is to assesss the safety and immunogenicity of vaccine based on Modified Vaccinia Ankara (MVA) expressing the 85A antigen (from Mycobacterium.
tuberculosis). This vaccine is delivered intrdermally by a needle injection in healthy volunteers.
| Condition | Intervention | Phase |
|---|---|---|
|
Tuberculosis |
Biological: MVA85A (Tuberculosis vaccine) |
Phase I |
| Study Type: | Interventional |
| Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| 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. |
| Estimated Enrollment: | 14 |
| Study Start Date: | September 2002 |
| Estimated Study Completion Date: | July 2003 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United Kingdom, Oxfordshire | |
| University of Oxford, Centre for Clinical Vaccinology and Tropical Medicine | |
| Oxford, Oxfordshire, United Kingdom, OX3 7LJ | |
| Principal Investigator: | Helen McShane, MD and PhD | University of Oxford |
More Information
| Study ID Numbers: | TB002 |
| Study First Received: | January 17, 2007 |
| Last Updated: | January 17, 2007 |
| ClinicalTrials.gov Identifier: | NCT00423566 History of Changes |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Mycobacterium tuberculosis 85A antigen Recombinant Modified Vaccinia virus Ankara Phase I study Immunogenicity |
|
Bacterial Infections Virus Diseases Gram-Positive Bacterial Infections Vaccinia |
Mycobacterium Infections Tuberculosis Healthy |
|
Bacterial Infections Gram-Positive Bacterial Infections Mycobacterium Infections Tuberculosis Actinomycetales Infections |