Study of the Safety and Immunogenicity of an Adenovirus-based Tuberculosis Vaccine

Inclusion Criteria:

• Healthy human subjects who are between 18 and 55 years of age with or without a history of BCG vaccination.
• HIV antibody negative
• For women, negative pregnancy test and practising two acceptable forms of contraception for the duration of the study (barrier contraceptive, birth control pill, surgically sterile, post-menopausal 2yrs, abstinence)
• For men, using barrier contraception for the duration of the study

Exclusion Criteria:

• Pregnant or lactating women
• Subjects who have any acute or chronic illnesses including active tuberculosis or receiving any drug treatment in the opinion of the investigator likely to affect the immune system.
• Subjects with symptoms suggestive of an upper respiratory tract infection (including cough, runny nose, or sore throat)
• Subjects who have a history of active or latent TB infection or whose PBMCs are strongly responsive to ESAT6/CFP10 stimulation using a commercial interferon gamma release assay for TB [consistent with latent TB infection].
• Subjects who have laboratory values outside the normal range.
• Not available for scheduled follow-up visits. Subjects enrolled in the trial must be followed at 7 days, and then at 2, 4, 8, 16 and 24 weeks post-vaccination.
• Failure to provide written consent.
• Known allergy to vaccine components
• Known exposure to active TB within past 6 months or subjects whose occupation puts them at increased risk of TB exposure (based on Hamilton Health Science/St Joseph Healthcare list of high risk personnel)
• Any abnormality on chest x-ray suggestive of active or remote tuberculosis infection.
• PPD skin test within last 12 months
• BCG status unknown