A Phase I Trial of a LTK63 Adjuvated Tuberculosis Nasal Subunit Vaccine (Ag85B-ESAT6) (TMUVA-01)

Inclusion Criteria:

• Signed informed consent
• Healthy, based on medical examination at inclusion
• Male or female subjects, aged between 18 and 55 years
• Willing and likely to be able to comply with the trial procedures
• Prepared to grant authorized persons access to their medical records

Additional inclusion criterion for BCG-non-vaccinated subjects:

• BCG-non-vaccinated (i.e., absence of a BCG-scar)
• Negative Mantoux skin test

Additional inclusion criterion for BCG-vaccinated subjects:

• BCG-vaccinated (i.e., presence of a BCG-scar)

Exclusion Criteria:

• History of TB or known exposure to TB
• Radiological findings on chest X ray compatible with previous or current infection with tuberculosis
• Positive QuantiFERON® TB-Gold test Evidence of previous, current or latent tuberculosis
• Evidence of previous, current or latent tuberculosis
• History of severe organ-system diseases
• Known hypersensitivity to any of the vaccine components
• History of allergic disorders
• Vaccinated with other vaccine within 3 months before first vaccination
• Congenital and/or acquired immune diseases
• Administration of systemic immune modulating drugs (steroids, immunosuppressive drugs or immunoglobulin) within 3 months before the first vaccination (topical steroids not included)
• Autoimmune diseases
• HIV, HBV and HCV sero-positive
• Established diagnosis of a neurological or neuromuscular disease, and specifically any history of abnormality with respect to sense of smell (olfactory nerve dysfunction), or previous or current facial nerve paralysis
• Congenital or acquired abnormalities or disorders related to nasal and nasopharyngeal cavities
• Current use of any medication taken through the nasal/inhalatory route including cocaine or other drugs
• Laboratory parameters outside of normal ranges considered clinically significant
• Pregnant according to urine pregnancy test
• Females not willing to use contraceptives or who are breastfeeding
• Intake of trial medication in other clinical trials within 6 months of the first vaccination