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 Who Have Received BCG Immunisation 1 Month Previously
This is a phase I study to test the immunogenicity of a recombinant vaccine based on Modified Vaccinia Ankara (MVA) expressing the antigen 85A (from Mycobacterium tuberculosis). This vaccine is delivered intradermally by a needle injection in healthy volunteers previously vaccinated with BCG.
Status | Completed |
Enrollment | 12 |
Est. completion date | March 2005 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
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/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. - Heaf test greater than Grade 0 - 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 | Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford, Churchill Hospital | Oxford | Oxfordshire |
Lead Sponsor | Collaborator |
---|---|
University of Oxford |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 mmunisation (and after 7 days). | |||
Primary | Blood will be taken at: the screening visit, prior to the BCG vaccination, 1 and 4 weeks after the BCG vaccination, and also at 1,4, 8, 12 and 24 weeks after the MVA85A vaccination. | |||
Secondary | 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. | |||
Secondary | Proliferation assays and cytotoxic T cell assays will be performed. Other serological measures of immune response, i.e. antibody titres will be analysed on frozen plasma samples. |
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