Status:
COMPLETED
A Phase I Study of the Safety and Immunogenicity of a Recombinant MVA Vaccine Encoding a Secreted Antigen From M. Tuberculosis, Antigen 85A, Delivered Intradermally by a Needle Injection in Healthy Volunteers Who Have Previously Received BCG
Lead Sponsor:
University of Oxford
Conditions:
Tuberculosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a phase I study to examine the safety and immunogenicity of MVA85A delivered intradermally into the deltoid region in volunteers who have recieved BCG in the past 20 years.
Detailed Description
This is a phase I study to examine the safety and immunogenicity of MVA85A delivered intradermally into the deltoid region in volunteers who have recieved BCG in the past 20 years 1\. Selection of vo...
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. Previous residence in a TB endemic area.
- 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
- Previous MVA immunisations
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
End Date :
January 1 2005
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00427830
Start Date
May 1 2003
End Date
January 1 2005
Last Update
January 29 2007
Active Locations (1)
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1
Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford, Churchill Hospital
Oxford, Oxfordshire, United Kingdom, OX3 7LJ