Tuberculosis Clinical Trial
Official title:
Safety and Immunogenicity of Candidate Tuberculosis (TB) Vaccine MVA85A Administered by the Intramuscular Route and the Intradermal Route: a Phase I Randomised Active Controlled Trial
This is a phase I study that will compare the safety and immunogenicity of candidate tuberculosis (TB) vaccine MVA85A administered by the intramuscular route and the intradermal route in healthy adult individuals who have been previously vaccinated with Bacillus Calmette-Guerin (BCG).
Status | Completed |
Enrollment | 24 |
Est. completion date | January 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: 1. Healthy adult aged 18 - 55 years (both male and female) 2. Resident in or near Oxford for the duration of the study period 3. Confirmation of prior vaccination with BCG not less than 3 months prior to projected study vaccination date (by visible BCG scar on examination or written documentation) 4. Normal medical history and physical examination 5. Willingness to allow the Investigators to discuss the individual's medical history with their GP 6. Willingness to use continuous effective barrier contraception for three months after receiving the vaccination (males and females) 7. Willingness to use effective contraception for the duration of the study period (females only) 8. Agreement to refrain from blood donation during the course of the study 9. Give written informed consent 10. Agreement to allow the Investigator to register volunteer details with a confidential database to prevent concurrent entry into clinical trials 11. Able and willing (in the Investigator's opinion) to comply with all the study requirements Exclusion Criteria: 1. Clinical, radiological, or laboratory evidence of current active TB infection 2. Laboratory evidence at screening of latent TB infection as indicated by a positive ELISPOT test (greater than 17 sfc/million PBMC) in any ESAT6 peptide or CFP10 peptide poola 3. Previous vaccination with candidate vaccine MVA85A or another recombinant MVA vaccine 4. Clinically significant history of skin disorder, allergy, immunodeficiency (including human immunodeficiency virus [HIV]), cancer (except basal cell carcinoma [BCC] or carcinoma in situ [CIS]), cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, neurological illness, psychiatric disorder, drug or alcohol abuse 5. History of serious psychiatric condition 6. Concurrent oral or systemic steroid medication or the use of other immunosuppressive agents 7. History of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the study vaccine 8. Any clinically significant abnormality of screening blood or urine tests 9. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) or HIV antibodies 10. Female currently lactating, confirmed pregnancy or intention to become pregnant during study period 11. Use of an investigational medicinal product or non-registered drug, live vaccine, or medical device other than the study vaccine for 30 days prior to dosing with the study vaccine, or planned use during the study period 12. Administration of immunoglobulins and/or any blood products within the three months preceding the planned trial vaccination date 13. Any other significant disease, disorder, or finding, which, in the opinion of the Investigator, may either put the volunteer at risk or may influence the result of the study or may affect the volunteer's ability to participate in the study |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United Kingdom | Centre of Clinical Vaccinology and Tropical Medicine (CCVTM) Churchill Hospital | Oxford |
Lead Sponsor | Collaborator |
---|---|
University of Oxford |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety | Safety data in both groups, as assessed by the frequency, incidence, and nature of adverse events (AEs) and serious adverse events (SAEs) during the study. Safety is measured throughout the 6 months follow up period, but specifically on the following days: 2, 7, 14, 28, 56, 84 and 168 and. Blood for safety testing is taken at Days 7 and 28. | 6 months following vaccination | Yes |
Secondary | Immunogenicity | Immunogenicity data in both groups. This will be obtained from exploratory immunological laboratory investigations on blood samples taken at screening, and throughout follow up. Immunogenicity is measured throughout the 6 months follow up period, but specifically on the following days: 2, 7, 14, 28, 56, 84 and 168. | 6 months following vaccination | No |
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