A Study of 2 Doses of a New TB Vaccine, MVA85A, in Healthy Volunteers Previously Vaccinated With BCG

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00465465
• Date of registration: 24/04/2007
• Prospective Registration: No
• Primary sponsor: University of Oxford
• Public title: A Study of 2 Doses of a New TB Vaccine, MVA85A, in Healthy Volunteers Previously Vaccinated With BCG
• Scientific title: A Dose Selection Study Evaluating the Safety and Immunogenicity of 2 Different Doses of a New TB Vaccine, MVA85A, in Healthy Volunteers Who Have Previously Been Vaccinated With BCG
• Date of first enrolment: October 2005
• Target sample size: 24
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00465465
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy 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 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 negative (less than 10 sfc/million PBMC) for all 3 ESAT6 peptide
pools and all 3 CFP10 peptide pools

- Mantoux test not greater than 15 millimetres

- 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 test

Exclusion Criteria:

- Any deviation from the normal range in biochemistry or haematology blood tests or in
urine analysis as defined in Appendix I

- Mantoux greater than 15 millimetres

- 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.

- 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

- Chronic gastrointestinal disease requiring ongoing specialist supervision

- History of > 2 hospitalisations for invasive bacterial infections (pneumonia,
meningitis)

- Suspected or known current 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)

- Evidence of serious psychiatric condition

- Any other on-going chronic illness requiring hospital specialist supervision

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

- Pregnant or lactating female

- Female who is willing or intends to become pregnant during the study

- Any history of anaphylaxis in reaction to vaccination

- Inability to give informed consent

- PI assessment of lack of willingness to participate and comply with all requirements
of the protocol

- Any other finding which in the opinion of the investigator would significantly
increase the risk of having an adverse outcome from participating in this protocol



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)

To assess the safety and immunogenicity of 2 different doses of intradermal vaccination of MVA85A, 10^7pfu and 10^8pfu, when administered to healthy subjects who have previously been vaccinated with BCG [Time Frame: 1 year]

Secondary ID(s)

TB009

Source(s) of Monetary Support

Please refer to primary and secondary sponsors