Status:
COMPLETED
A Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis(TB) Subunit Vaccine
Lead Sponsor:
Statens Serum Institut
Conditions:
Tuberculosis
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety profile of an adjuvanted TB subunit vaccine administered at 0 and 2 months in healthy BCG-unvaccinated volunteers with no prior history of TB diseas...
Eligibility Criteria
Inclusion
- Male
- Healthy based on medical examination/history at the inclusion
- Age between 18 and 55 years
- Signed informed consent
- Prepared to grant authorized persons access to the medical records
- The volunteer is likely to comply with instructions
Exclusion
- Known exposure to TB before (or expected during) the trial
- Prior BCG vaccination
- Granulomatous disease (by chest X-ray, autoimmune screen)
- Vaccinated with live vaccine 3 months before first vaccination
- Administration of immune modulating drugs (steroids, immunosuppressive drugs or immunoglobulins) 3 months before the first vaccination
- HBV, HCV or HIV sero-positive (HBsAg, HBsAb, HBc total and IgM ab and HCV, HIV-1 and HIV2 ab)
- Participation in other clinical trials
- Positive Mantoux or QuantiFERON-TB Gold
- Known hypersensitivity to any of the vaccine components
- Laboratory parameters outside of normal ranges considered clinically relevant
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01003093
Start Date
November 1 2005
End Date
June 1 2008
Last Update
January 21 2013
Active Locations (1)
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1
Leiden University Medical Centre
Leiden, RC Leiden, Netherlands, 2300