Status:
COMPLETED
A Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis (TB) Subunit Vaccine in Purified Protein Derivative (PPD) Positive Volunteers
Lead Sponsor:
Statens Serum Institut
Conditions:
Tuberculosis
Eligibility:
All Genders
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.
Eligibility Criteria
Inclusion
- Male and female between 18 and 55 years old
- BCG group: Known to be BCG-vaccinated over 2 years before, PPD positive (range 6-15 mm or any documented value between 6-15 mm on medical file in the past), with no active, chronic or past TB disease as confirmed by chest X ray, negative QuantiFERON-TB Gold In Tube test and negative 6-day lymphocyte tests.
- Infection group: Known to be treated for latent TB, PPDpositive (equal or over 10 mm or documented equal or over 10 mm positive on medical file in the past), previously TB infected but with no active disease confirmed by chest X ray, may have received chemoprophylaxis but with no TB treatment/chemoprophylaxis within the preceding 2 years, positive QuantiFERON-TB Gold In Tube test and/or positive 6-day lymphocyte test.
- Healthy based on medical examination/history at the inclusion
- Signed informed consent
- Prepared to grant authorized persons access to the medical records
- The volunteer is likely to comply with instructions
Exclusion
- Granulomatous disease (by chest X-ray)
- 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
- Participation in other clinical trials
- Known hypersensitivity to any of the vaccine components
- Laboratory parameters outside of normal range judged by PI to be clinically relevant
- Pregnant women/planned pregnancy and/or breastfeeding within the trial period
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00929396
Start Date
September 1 2007
End Date
June 1 2009
Last Update
January 21 2013
Active Locations (1)
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1
Leiden University Medical Centre
Leiden, RC Leiden, Netherlands, 2300