Status:
COMPLETED
A Study of 2 Doses of a New TB Vaccine, MVA85A, in Healthy Volunteers Previously Vaccinated With BCG
Lead Sponsor:
University of Oxford
Conditions:
Tuberculosis
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
The dose of recombinant MVA used in the TB trials to date is relatively low compared with other trials using recombinant MVAs which have used up to 2.5 x 108pfu (A Hill, personal communication). Havin...
Detailed Description
MVA85A (at a dose of 5 x 107pfu) has been administered to 41 healthy volunteers in the UK and 17 healthy volunteers in The Gambia, with no serious adverse events. We have designed our Phase I studies ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00465465
Start Date
October 1 2005
End Date
September 1 2007
Last Update
April 4 2008
Active Locations (1)
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1
University of Oxford, CCVTM, Churchill Hospital
Oxford, Oxfordshire, United Kingdom, OX3 7LJ