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Sponsors and Collaborators: |
University of Oxford Centre Hospitalier Universitaire Le Dantec, Dakar, Senegal |
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Information provided by: | University of Oxford |
ClinicalTrials.gov Identifier: | NCT00731471 |
This is an open Phase I study of a candidate TB vaccine, MVA85A, in healthy subjects who are infected with HIV. It is designed to study the safety and immunogenicity of the vaccine.
Condition | Intervention | Phase |
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Tuberculosis |
Biological: MVA85A |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase I Study Evaluating the Safety and Immunogenicity of a New TB Vaccine, MVA85A, in Healthy Volunteers Who Are Infected With HIV |
Estimated Enrollment: | 12 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
12 Healthy adults infected with HIV
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Biological: MVA85A
Modified vaccinia virus Ankara expressing antigen 85A from Mycobacterium tuberculosis
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This study is designed to evaluate the safety of MVA85A in healthy volunteers in Senegal who are infected with HIV. In phase I studies, a single vaccination with MVA85A, when administered at a dose of 5 x 107pfu intradermally, has been shown to be safe in both mycobacterially naïve individuals, those previously vaccinated with BCG and latently infected individuals. We will use 1 x 10^8 pfu MVA85A intradermally in this study. A trial in BCG vaccinated subjects showed that the higher dose (1 x 10^8 pfu MVA85A) induced a significantly higher immune response but did not have a higher AE profile. In addition, because of a variable immune response, the trial in HIV positive subjects in the UK is split into two groups, the first getting 5 x 10^7 pfu and the second getting 1 x 10^8 pfu MVA85A. It has, therefore, been decided to use the higher dose in order to maximise the immune response whilst maintaining a good safety profile.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Senegal | |
Centre Hospitalier Le Dantec | |
Dakar, Senegal, BP 7325 |
Principal Investigator: | Helen McShane | University of Oxford |
Principal Investigator: | Souleymane Mboup | Centre Hospitalier Universitaire Le Dantec |
Responsible Party: | University of Oxford ( Dr Helen McShane ) |
Study ID Numbers: | TB019 |
Study First Received: | August 6, 2008 |
Last Updated: | August 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00731471 |
Health Authority: | Senegal: Ministere de la sante |
Bacterial Infections Gram-Positive Bacterial Infections HIV Infections Acquired Immunodeficiency Syndrome |
Mycobacterium Infections Tuberculosis Healthy |
Actinomycetales Infections |