NL-OMON30684
Completed
Not Applicable
A safety and immunogenicity phase 1 trial with an adjuvated TB subunit vaccine (Ag85B - ESAT-6 + IC31) administered in PPD positive volunteers at 0 and 2 months - THYB-02
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prevention
- Sponsor
- Statens Serum Institut
- Enrollment
- 20
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •BCG\-group: BCG\-vaccinated \> two years before, PPD\+ (range 6\-15mm) or any documented value between 6\-15mm 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 diagnosed with latent TB, PPD\+, 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
- •Age between 18 and 55 ears
- •Signed informed consent
Exclusion Criteria
- •Granulomatous disease other then TB
- •Vaccinated with live vaccine 3 months before the first vaccination
- •Administration of immune modilating drugs 3 months before first vaccination
- •HBV, HCV, or HIV sero\-positive
- •Participation in another clinical trial
- •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 trail period
Outcomes
Primary Outcomes
Not specified
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