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Sponsored by: |
University of Oxford |
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Information provided by: | University of Oxford |
ClinicalTrials.gov Identifier: | NCT00395720 |
This study is designed to evaluate the safety of MVA85A in healthy volunteers in the UK who are infected with HIV. In phase I studies, a single vaccination with MVA85A, when administered at a dose of 5 x 10^7pfu intradermally, has been shown to be safe in both mycobacterially naïve individuals, those previously vaccinated with BCG and latently infected individuals. Additionally, 5 x 10^7 pfu MVA containing HIV antigens administered twice, 4 weeks apart, in HIV positive individuals, is safe. We will use 5 x 107 pfu MVA85A intradermally in this study. Subjects will be identified from HIV clinics in the Oxford Radcliffe Hospitals NHS Trust and also from Swindon and Marlborough NHS Trust and St. Mary's Hospital NHS Trust if our recruitment targets are not met.
Condition | Intervention | Phase |
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Tuberculosis HIV Infections |
Biological: MVA85A (TB vaccine) Biological: MVA 85A |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Parallel 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: | 20 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | October 2008 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Group 1 (10 volunteers): 5 x 10^7 pfu
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Biological: MVA85A (TB vaccine)
Intradermal vaccine
Biological: MVA 85A
Intradermal vaccine
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2: Active Comparator
Group 2 (10 volunteers): 1 x 10^8 pfu
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Biological: MVA85A (TB vaccine)
Intradermal vaccine
Biological: MVA 85A
Intradermal vaccine
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Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
(For corticosteroids, this will mean prednisolone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
Contact: Helen McShane, Dr | 01865 857417 | helen.mcshane@ndm.ox.ac.uk |
Contact: Angela Minnasian, Dr | 01865 857425 | angela.minassian@ndm.ox.ac.uk |
United Kingdom, Oxfordshire | |
Centre for Clinical Vaccinology and Tropical Medicine | Recruiting |
Oxford, Oxfordshire, United Kingdom, OX3 7LJ |
Principal Investigator: | Helen McShane, Dr | University of Oxford |
Responsible Party: | University of Oxford ( Dr Helen McShane ) |
Study ID Numbers: | TB010 |
Study First Received: | November 2, 2006 |
Last Updated: | April 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00395720 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
TB Tuberculosis HIV Vaccine |
MVA85A HIV HIV Therapeutic Vaccine |
Bacterial Infections Virus Diseases Gram-Positive Bacterial Infections Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Mycobacterium Infections Tuberculosis Healthy Retroviridae Infections Immunologic Deficiency Syndromes |
Bacterial Infections RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Actinomycetales Infections Immunologic Deficiency Syndromes |
Virus Diseases Gram-Positive Bacterial Infections HIV Infections Sexually Transmitted Diseases Lentivirus Infections Mycobacterium Infections Tuberculosis Retroviridae Infections |