Status:
COMPLETED
Study of the Safety and Immunogenicity of Bacille Calmette Guerin (BCG) Vaccine
Lead Sponsor:
University of Oxford
Conditions:
TB
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
Tuberculosis (TB) kills about three million people annually. It is estimated that one third of the world's population are latently infected with Mycobacterium tuberculosis (M.tb). Multi-drug resistant...
Detailed Description
Recombinant viruses as vaccines. Recombinant viruses used alone have for some years represented a promising vaccine delivery system, particularly for inducing cellular immune responses8. The recombin...
Eligibility Criteria
Inclusion
- Healthy adult aged 18-55 years.
- Normal medical history and physical examination.
- Normal urine dipstick, blood count, liver enzymes, and creatinine.
Exclusion
- Exposure to TB at any point. A positive ESAT6/CFP10 Elispot response (defined as greater than 5 spots/well above background and at least double the background response).
- Clinically significant history of skin disorder (eczema, psoriasis, etc.), allergy, immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness, psychiatric disorder, drug or alcohol abuse.
- Oral or systemic steroid medication or the use of immunosuppressive agents.
- Positive HIV antibody test, HCV antibody test or positive HBV serology except post-vaccination.
- Heaf test greater than Grade II
- Confirmed pregnancy
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00654316
Start Date
February 1 2004
End Date
November 1 2005
Last Update
April 7 2008
Active Locations (1)
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1
Centre for Clinical Vaccinology and Tropical Medicine
Oxford, Oxfordshire, United Kingdom, OX3 7LJ