Tuberculosis Clinical Trial
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.
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.
Status | Completed |
Enrollment | 14 |
Est. completion date | July 2003 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Healthy adult aged 18-45 years. - Normal medical history and physical examination. - Normal urine dipstick, blood count, liver enzymes, and creatinine. Exclusion Criteria: - Exposure to TB/BCG vaccination 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. - Positive Heaf test - Confirmed pregnancy - Previous MVA immunisations |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Oxford, Centre for Clinical Vaccinology and Tropical Medicine | Oxford | Oxfordshire |
Lead Sponsor | Collaborator |
---|---|
University of Oxford |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Local and systemic reactions will be monitored 30 and 60 minutes after administration. | |||
Primary | A photograph of the injection will be taken at 48 hours and this injection site will be reviewed 7 days after each immunisation. | |||
Primary | Blood will be taken: 1 week after the first vaccination, 1 week after the second vaccination and then at 4, 8, 12 and 24 weeks. The blood is used for a full blood count and biochemical screen. | |||
Primary | Immunological assays are performed at all time points to determine vaccine imunogenicity (T cell responses are measured using an interferon-gamma Elispot assay). | |||
Secondary | Immunological assays are performed at all time points to determine vaccine imunogenicity (T cell responses are measured using an interferon-gamma Elispot assay). |
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