A Phase I Study of a New Tuberculosis (TB) Vaccine, MVA85A, in Healthy Volunteers With HIV
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ClinicalTrials.gov Identifier: NCT00731471 |
Recruitment Status
:
Completed
First Posted
: August 11, 2008
Last Update Posted
: March 28, 2011
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Sponsor:
University of Oxford
Collaborator:
Centre Hospitalier Universitaire Le Dantec, Dakar, Senegal
Information provided by:
University of Oxford
Tracking Information | |||||||
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First Submitted Date ICMJE | August 6, 2008 | ||||||
First Posted Date ICMJE | August 11, 2008 | ||||||
Last Update Posted Date | March 28, 2011 | ||||||
Study Start Date ICMJE | August 2008 | ||||||
Actual Primary Completion Date | January 2011 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Safety of MVA85A [ Time Frame: Six months ] | ||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | Complete list of historical versions of study NCT00731471 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
Immunogenicity of MVA85A [ Time Frame: Six months ] | ||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Outcome Measures ICMJE | Not Provided | ||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | A Phase I Study of a New Tuberculosis (TB) Vaccine, MVA85A, in Healthy Volunteers With HIV | ||||||
Official Title ICMJE | A Phase I Study Evaluating the Safety and Immunogenicity of a New TB Vaccine, MVA85A, in Healthy Volunteers Who Are Infected With HIV | ||||||
Brief Summary | 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. | ||||||
Detailed Description | 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. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase | Phase 1 | ||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE | Tuberculosis | ||||||
Intervention ICMJE | Biological: MVA85A
Modified vaccinia virus Ankara expressing antigen 85A from Mycobacterium tuberculosis. Both arms will receive two vaccinations six months apart. |
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Study Arms |
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Publications * | Dieye TN, Ndiaye BP, Dieng AB, Fall M, Brittain N, Vermaak S, Camara M, Diop-Ndiaye H, Ngom-Gueye NF, Diaw PA, Toure-Kane C, Sow PS, Mboup S, McShane H. Two doses of candidate TB vaccine MVA85A in antiretroviral therapy (ART) naïve subjects gives comparable immunogenicity to one dose in ART+ subjects. PLoS One. 2013 Jun 28;8(6):e67177. doi: 10.1371/journal.pone.0067177. Print 2013. Erratum in: PLoS One. 2013;8(10). doi:10.1371/annotation/67550546-cacf-4063-8d62-d165da14ca61. Britain, Nathaniel [corrected to Brittain, Nathaniel]. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Estimated Enrollment ICMJE |
24 | ||||||
Original Estimated Enrollment ICMJE |
12 | ||||||
Actual Study Completion Date | January 2011 | ||||||
Actual Primary Completion Date | January 2011 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 50 Years (Adult) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Senegal | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00731471 | ||||||
Other Study ID Numbers ICMJE | TB019 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Dr Helen McShane, University of Oxford | ||||||
Study Sponsor ICMJE | University of Oxford | ||||||
Collaborators ICMJE | Centre Hospitalier Universitaire Le Dantec, Dakar, Senegal | ||||||
Investigators ICMJE |
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PRS Account | University of Oxford | ||||||
Verification Date | March 2011 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |