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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00427830 |
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Date of registration:
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25/01/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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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Date of first enrolment:
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May 2003 |
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Target sample size:
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16 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00427830 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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Phase 1
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Helen McShane, MD and PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Oxford |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy adult aged 18-55 years.
- Normal medical history and physical examination.
- Normal urine dipstick, blood count, liver enzymes, and creatinine.
Exclusion Criteria:
- Exposure to TB at any point. Previous residence in a TB endemic area.
- Clinically significant history of skin disorder (eczema, psoriasis, etc.), allergy,
immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder,
liver disease, renal disease, gastrointestinal disease, neurological illness,
psychiatric disorder, drug or alcohol abuse.
- Oral or systemic steroid medication or the use of immunosuppressive agents.
- Positive HIV antibody test, HCV antibody test or positive HBV serology except
post-vaccination.
- Heaf test greater than Grade II
- Confirmed pregnancy
- Previous MVA immunisations
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Tuberculosis
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Intervention(s)
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Biological: MVA85A
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Primary Outcome(s)
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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).
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Secondary Outcome(s)
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Proliferation assays and cytotoxic T cell assays will be performed on strong CD4+ and CD8+ responses respectively.
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Antibody titres will be measured from frozen plasma samples.
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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.
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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