A Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis(TB) Subunit Vaccine

A Safety and Immunogenicity Phase 1 Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31) Administered at 0 and 2 Months

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 disease or known prior exposure to TB

Inclusion Criteria:

• 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 Criteria:

• 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