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Full eligibility criteria for NCT00929396
Ages eligible for Study
18 Years to 55 Years
Genders eligible for Study
Accepts Healthy Volunteers
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
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
All locations for NCT00929396
Leiden University Medical Centre
Leiden, RC Leiden, Netherlands, 2300
View full eligibility
Tris trial is registered with FDA with number: NCT00929396. The sponsor of the trial is Statens Serum Institut and it is looking for 20 volunteers for the current phase.
Official trial title: A Safety and Immunogenicity Phase 1 Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31)Administered in PPD Positive Volunteers at 0 and 2 Months
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