Safety and Immunogenicity of MVA85A in Volunteers Latently Infected With TB.

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00456183
• Date of registration: 03/04/2007
• Prospective Registration: No
• Primary sponsor: University of Oxford
• Public title: Safety and Immunogenicity of MVA85A in Volunteers Latently Infected With TB.
• Scientific title: A Phase I Study Evaluating the Safety and Immunogenicity of a New TB Vaccine, MVA85A, in Healthy Volunteers Who Are Latently Infected With Mycobacterium Tuberculosis.
• Date of first enrolment: August 2005
• Target sample size: 12
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00456183
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group 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 adults aged 18 to 50 years

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

- Willingness to allow the investigators to discuss the volunteer’s medical history
with the volunteer’s GP

- Screening Elispot positive (more than 50 spots/million PBMC) for at least any 1 of
the 3 ESAT6 peptide pools or any one of the 3 CFP10 pools ; and screening Elispot
positive for PPD.

- Heaf test grade II-IV or positive Mantoux test.

- CXR normal; or abnormal but not clinically significant CXR findings with no evidence
of past/present TB infection or disease on the CXR.

- For females only, willingness to practice continuous effective contraception during
the study and a negative pregnancy test on the day of vaccination

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

- Written informed consent

- Willingness to undergo an HIV

Exclusion Criteria

- Any deviation from the normal range in biochemistry or haematology blood tests or in
urine analysis

- Heaf grade IV

- Prior receipt of a recombinant MVA or Fowlpox vaccine

- Use of any investigational or non-registered drug, live vaccine or medical device
other than the study vaccine within 30 days preceding dosing of study vaccine, or
planned use during the study period

- Administration of chronic (defined as more than 14 days) immunosuppressive drugs or
other immune modifying drugs within six months of vaccination. (For corticosteroids,
this will mean prednisolone, or equivalent, e 0.5 mg/kg/day. Inhaled and topical
steroids are allowed.)

- Any confirmed or suspected immunosuppressive or immunodeficient condition, including
human immunodeficiency virus (HIV) infection and asplenia

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

- Evidence of cardiovascular disease

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

- History of insulin requiring diabetes mellitus

- Chronic or active neurological disease requiring ongoing specialist supervision



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

Health Condition(s) or Problem(s) studied

Tuberculosis

Intervention(s)

Biological: MVA 85A

Primary Outcome(s)

Safety of a single intradermal injection of 5 x 107pfu MVA85A [Time Frame: One year]

Secondary Outcome(s)

the vaccine) and to ESAT6/CFP10 antigens (M.tb specific).

Endpoints:

Efficacy [Time Frame: One year]

data on adverse events (AEs). The specific endpoints for immunogenicity will be markers of

latently infected with MVA85A on the immune response, both to antigen 85A (the antigen in

The specific endpoints for safety and reactogenicity will be actively and passively collected

cell-mediated immunity as described below.

Secondary ID(s)

TB007

Source(s) of Monetary Support

Please refer to primary and secondary sponsors