|
Welcome
|
|
11 February 2012
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| A phase I study to assess the safety and immunogenicity of new tuberculosis (TB) vaccine candidates FP85A and MVA85A, in healthy adults who have previously been immunised with Bacillus Calmette-Guerin (BCG), using a prime-boost delivery schedule |
| ISRCTN | ISRCTN12385972 |
| ClinicalTrials.gov identifier | NCT00653770 |
| Public title | A phase I study to assess the safety and immunogenicity of new tuberculosis (TB) vaccine candidates FP85A and MVA85A, in healthy adults who have previously been immunised with Bacillus Calmette-Guerin (BCG), using a prime-boost delivery schedule |
| Scientific title | The safety and immunogenicity of new tuberculosis (TB) vaccine candidates FP85A and MVA85A, in healthy adults who have previously been immunised with Bacillus Calmette-Guerin (BCG), using a prime-boost delivery schedule: a phase I open label study |
| Acronym | N/A |
| Serial number at source | 076943; TB017 |
| Study hypothesis | This is a phase I study whose primary outcome is to assess the safety of a new tuberculosis (TB) vaccine, FP85A, when administered individually and sequentially with MVA85A in a prime-boost regime, to healthy volunteers, who have previously been vaccinated with Bacillus Calmette-Guerin (BCG). The secondary outcome is to assess the cellular immune response in the same population. The trial consists of 36 subjects in three groups. The first group will be vaccinated with FP85A alone, the second group will be vaccinated with MVA85A followed by FP85A 28 days later and the third group will be vaccinated with FP85A followed by MVA85A 28 days later. |
| Lay summary | |
| Ethics approval | Gene Therapy Advisory Committee (GTAC) approved on the 29th March 2007 (ref: GTAC 130; EudraCT No.: 2007-000014-37) |
| Study design | Open label three arm active-controlled phase I study |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Tuberculosis |
| Participants - inclusion criteria |
1. Healthy adult aged 18 to 50 years (male or female)
2. Resident in or near Oxford for the duration of the vaccination study 3. Immunisation with BCG greater than 12 months prior to enrolment in the study 4. Able and willing (in the Investigators’ opinions) to comply with all study requirements 5. Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner 6. Agreement to practice barrier contraception from the start of the study until 3 months after the final vaccination 7. For females, a negative pregnancy test on the day of vaccination and agreement to practice effective contraception for the entire duration of the study 8. Agreement to refrain from blood donation during the course of the study 9. Written informed consent |
| Participants - exclusion criteria |
1. Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period
2. Prior receipt of a recombinant MVA or fowlpox vaccine 3. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate 4. Any confirmed or suspected immunosuppressive or immunodeficient state, including human immunodeficiency virus (HIV) infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed) 5. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products 6. Any history of anaphylaxis in reaction to vaccination 7. Close contact with fowl during the study period (e.g. chicken farming) 8. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ) 9. History of serious psychiatric condition 10. Any other chronic illness requiring hospital specialist supervision 11. Suspected or known current injecting drug or alcohol abuse (as defined by an alcohol intake of greater than 42 units every week) 12. Seropositive for hepatitis B surface antigen (HBsAg) 13. Seropositive for hepatitis C virus (antibodies to HCV) 14. For females, pregnancy, lactation or willingness/intention to become pregnant during the study 15. Any other significant disease, disorder or finding, which, in the opinion of the Investigators, may either put the volunteer at risk because of participation in the study, or may influence the result of the study, or the volunteer's ability to participate in the study 16. Mantoux skin test equal to or greater than 15 millimetres 17. Screening Elispot positive (greater than 17 sfc/million PBMC) in any ESAT6 peptide or CFP10 peptide pool 18. Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis |
| Anticipated start date | 16/07/2007 |
| Anticipated end date | 01/02/2010 |
| 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 | 36 |
| Interventions |
FP85A is a modified fowlpox virus expressing antigen 85A from Mycobacterium tuberculosis. MVA85A is a modified vaccinia virus Ankara expressing antigen 85A from Mycobacterium tuberculosis. Dosing is as follows:
Group 1: 1 dose of FP85A day 0 Group 2: 1 dose of MVA85A day 0; 1 dose of FP85A day 28 Group 3: 1 dose of FP85A day 0; 1 dose of MVA85A day 28 There is no control group. Total duration of follow-up: 12 months |
| Primary outcome measure(s) | To assess the safety of a new tuberculosis vaccine, FP85A, when administered individually and sequentially with MVA85A in a prime-boost regime to healthy volunteers, who have previously been vaccinated with BCG. Safety is measured throughout the one year follow up period, but specifically on the following days: 2, 7, 28, 56, 84, 168 and 364. Blood for safety testing is taken at Days 7 and 28. |
| Secondary outcome measure(s) | To assess the cellular immune response generated by FP85A, when administered individually and sequentially with MVA85A in a prime-boost regime to healthy volunteers, who have previously been vaccinated with BCG. Immunogenicity is measured throughout the one year follow up period, but specifically on the following days: 2, 7, 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 |
|
|
|
|
|
| © 2012 ISRCTN unless otherwise stated. | |
|
|
|
|