Trial on the Safety of a New Liposomal Adjuvant System, CAF01, When Given With the Tuberculosis Subunit Vaccine Ag85B-ESAT-6 as Two Injections With Two Months Interval to Healthy Adult Volunteers

Inclusion Criteria: 1. Female or male adult between 18 and 55 years of age 2. Healthy according to medical history and medical examinations at screening 3. Signed informed consent 4. Prepared to grant authorized persons access to medical records 5. Likely to comply with instructions Exclusion Criteria: 1. History of tuberculosis or known exposure to tuberculosis before (or expected during) the clinical trial 2. Positive Tuberculin Skin Test (TST) result at screening 3. Positive QuantiFERON® -TB Gold In-Tube test result according to the manufacturer's specifications at screening 4. BCG vaccination any time before entering the trial 5. History of or ongoing congenital or acquired immune deficiency, autoimmune disease or thyroid dysfunction 6. Disease affecting the lymphoid organs (Hodgkin's disease, lymphoma, leukaemia, sarcoidosis) 7. ANA-Titer, HBV, HCV, HIV sero-positive at screening 8. C-reactive protein level \> 50 mg/L at screening 9. Clinically significant abnormal laboratory test results at screening as assessed by the investigator 10. Severe ongoing viral or bacterial infection that might affect the cell mediated immune response 11. A condition in which repeated blood drawings pose more than minimal risk for the subject, such as haemophilia, other coagulation disorders, or significantly impaired venous access 12. Live vaccine vaccination (MMR, yellow fever, oral typhoid) within 3 months before the first vaccination 13. Immune modulating drugs administration (immunoglobulin, systemic corticosteroids, azathioprine, cyclosporine, infliximab, blood products or vaccines) within 3 months before the first vaccination 14. Known hypersensitivity to any of the vaccine components of the investigational vaccines 15. Intake of another clinical trial product/vaccine within 3 months before the first vaccination or participation in previous clinical trials with the Ag85B-ESAT-6 antigen 16. Pregnant according to a urine pregnancy test at inclusion 17. Females not willing to use contraceptives or breast feeding 18. Has a condition which in the opinion of the investigator is not suitable for participation in the clinical trial