A Phase I Study to Assess the Safety and Immunogenicity of Tuberculosis (TB) Vaccine Candidates FP85A and MVA85A

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00653770
• Date of registration: 02/04/2008
• Prospective Registration: No
• Primary sponsor: University of Oxford
• Public title: A Phase I Study to Assess the Safety and Immunogenicity of Tuberculosis (TB) Vaccine Candidates FP85A and MVA85A
• Scientific title: A Phase I Study to Assess the Safety and Immunogenicity of New TB Vaccine Candidates FP85A and MVA85A, in Healthy Adults Who Have Previously Been Immunized With BCG, Using a Prime-boost Delivery Schedule
• Date of first enrolment: September 2007
• Target sample size: 31
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00653770
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: Phase 1

Countries of recruitment

United Kingdom

Contacts

• Name: Helen McShane
• Affiliation: University of Oxford

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy adult aged 18 to 50 years

- Resident in or near Oxford for the duration of the vaccination study

- Immunization with BCG greater than 12 months prior to enrolment in the study

- Able and willing (in the Investigators' opinions) to comply with all study
requirements

- Willing to allow the investigators to discuss the volunteer's medical history with
their General Practitioner

- Agreement to practice barrier contraception from the start of the study until 3
months after the final vaccination

- For females, a negative pregnancy test on the day of vaccination and agreement to
practice effective contraception for the entire duration of the study

- Agreement to refrain from blood donation during the course of the study

- Written informed consent

Exclusion Criteria:

- Participation in another research study involving an investigational product in the
30 days preceding enrolment, or planned use during the study period

- Prior receipt of a recombinant MVA or fowlpox vaccine

- Administration of immunoglobulins and/or any blood products within the three months
preceding the planned administration of the vaccine candidate

- Any confirmed or suspected immunosuppressive or immunodeficient state, including 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)

- History of allergic disease or reactions likely to be exacerbated by any component of
the vaccine, e.g. egg products

- Any history of anaphylaxis in reaction to vaccination

- Close contact with fowl during the study period (e.g. chicken farming)

- History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in
situ)

- History of serious psychiatric condition

- Any other chronic illness requiring hospital specialist supervision

- Suspected or known current injecting drug or alcohol abuse (as defined by an alcohol
intake of greater than 42 units every week)

- Seropositive for hepatitis B surface antigen (HBsAg)

- Seropositive for hepatitis C virus (antibodies to HCV)

- For females, pregnancy, lactation or willingness/intention to become pregnant during
the study

- 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.

- Mantoux skin test equal to or greater than 15 millimetres

- Screening Elispot positive (greater than 17 sfc/million PBMC) in any ESAT6 peptide or
CFP10 peptide pool

- Any clinically significant abnormal finding on screening biochemistry or haematology
blood tests or urinalysis



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Tuberculosis

Intervention(s)

Biological: MVA85A

Biological: FP85A

Primary Outcome(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 [Time Frame: 3 months]

Secondary Outcome(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. [Time Frame: 12 months]

Secondary ID(s)

TB017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors