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| [ Print-friendly version ] |
| A phase I study to compare the safety and immunogenicity of candidate tuberculosis (TB) vaccine MVA85A administered by the intramuscular route and the intradermal route |
| ISRCTN | ISRCTN46804531 |
| ClinicalTrials.gov identifier | |
| Public title | A phase I study to compare the safety and immunogenicity of candidate tuberculosis (TB) vaccine MVA85A administered by the intramuscular route and the intradermal route |
| Scientific 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 |
| Acronym | N/A |
| Serial number at source | 076943; TB022 |
| Study hypothesis | 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). |
| Lay summary | |
| Ethics approval | Oxfordshire Research Ethics Committee (OXREC) approved on the 2nd December 2009 (ref: OXREC ref 09/H0604/128; EudraCT No.: 2009-015973-11) |
| Study design | Phase I randomised active controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Tuberculosis |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/01/2010 |
| Anticipated end date | 31/10/2010 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 24 |
| Interventions |
MVA85A is a modified vaccinia virus Ankara expressing antigen 85A from Mycobacterium tuberculosis. All subjects will receive a single vaccination of 1 x 10^8 pfu (plaque forming units) of MVA85A, one group via the intramuscular route and one group via the intradermal route.
Total duration of follow-up: 6 months. |
| Primary outcome measure(s) | 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 one year follow up period, but specifically on the following days: 2, 7, 14, 28, 56, 84, 168 and 364. Blood for safety testing is taken at Days 7 and 28. |
| Secondary outcome measure(s) | 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 one year follow up period, but specifically on the following days: 2, 7, 14, 28, 56, 84, 168 and 364. |
| Sources of funding | The Wellcome Trust (UK) - Senior Clinical Fellowship Grant (grant ref: 076943) |
| Trial website | |
| Publications | |
| Contact name | Dr Helen McShane |
| Address |
Jenner Institute
Old Road Campus Research Building University of Oxford |
| City/town | Oxford |
| Zip/Postcode | OX3 7DQ |
| Country | United Kingdom |
| Sponsor | University of Oxford (UK) |
| Address |
Centre of Clinical Vaccinology and Tropical Medicine (CCVTM)
Churchill Hospital |
| City/town | Oxford |
| Zip/Postcode | OX3 7LJ |
| Country | United Kingdom |
| Sponsor website: | http://www.ox.ac.uk/ |
| Date applied | 15/12/2009 |
| Last edited | 18/12/2009 |
| Date ISRCTN assigned | 18/12/2009 |
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| © 2012 ISRCTN unless otherwise stated. | |
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