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

Completed

• Conditions: Tuberculosis; Infections and Infestations; Miliary tuberculosis

• Registration Number: ISRCTN12385972
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-18
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 36

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.