Status:
TERMINATED
A Phase I Trial of a LTK63 Adjuvated Tuberculosis Nasal Subunit Vaccine (Ag85B-ESAT6)
Lead Sponsor:
St George's, University of London
Collaborating Sponsors:
Statens Serum Institut
Novartis Vaccines
Conditions:
Tuberculosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine whether a subunit tuberculosis vaccine given as two nasal immunizations composed of a hybrid protein antigen from M. tuberculosis virus mixed with a toxoid ad...
Detailed Description
The purpose of this study is to determine whether a subunit tuberculosis vaccine given as two nasal immunizations composed of a hybrid protein antigen from M. tuberculosis virus mixed with a toxoid ad...
Eligibility Criteria
Inclusion
- Signed informed consent
- Healthy, based on medical examination at inclusion
- Male or female subjects, aged between 18 and 55 years
- Willing and likely to be able to comply with the trial procedures
- Prepared to grant authorized persons access to their medical records
- Additional inclusion criterion for BCG-non-vaccinated subjects:
- BCG-non-vaccinated (i.e., absence of a BCG-scar)
- Negative Mantoux skin test
- Additional inclusion criterion for BCG-vaccinated subjects:
- BCG-vaccinated (i.e., presence of a BCG-scar)
Exclusion
- History of TB or known exposure to TB
- Radiological findings on chest X ray compatible with previous or current infection with tuberculosis
- Positive QuantiFERON® TB-Gold test Evidence of previous, current or latent tuberculosis
- Evidence of previous, current or latent tuberculosis
- History of severe organ-system diseases
- Known hypersensitivity to any of the vaccine components
- History of allergic disorders
- Vaccinated with other vaccine within 3 months before first vaccination
- Congenital and/or acquired immune diseases
- Administration of systemic immune modulating drugs (steroids, immunosuppressive drugs or immunoglobulin) within 3 months before the first vaccination (topical steroids not included)
- Autoimmune diseases
- HIV, HBV and HCV sero-positive
- Established diagnosis of a neurological or neuromuscular disease, and specifically any history of abnormality with respect to sense of smell (olfactory nerve dysfunction), or previous or current facial nerve paralysis
- Congenital or acquired abnormalities or disorders related to nasal and nasopharyngeal cavities
- Current use of any medication taken through the nasal/inhalatory route including cocaine or other drugs
- Laboratory parameters outside of normal ranges considered clinically significant
- Pregnant according to urine pregnancy test
- Females not willing to use contraceptives or who are breastfeeding
- Intake of trial medication in other clinical trials within 6 months of the first vaccination
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00440544
Start Date
January 1 2007
End Date
February 1 2008
Last Update
November 3 2008
Active Locations (1)
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1
St George's Vaccine Institute
London, England, United Kingdom, SW17 0RE