rBCG-N-RSV Vaccine in Adults Aged 60 Years and Older

This Phase 2 clinical study will evaluate the safety of the rBCG-N-RSV vaccine compared to conventional BCG in adults older than 60 years. It will also compare the cellular anti-mycobacterial immune response of both vaccines in adults older than 60 years and characterize the cellular immune response against RSV nucleoprotein (N) generated by the rBCG-N-RSV vaccine in adults older than 60 years as compared to the response induced by the conventional BCG.

Inclusion Criteria 1. Has completed the written informed consent process. 2. Males or females, over 60 years of age as of the date of signature of the informed consent form. 3. Has a stable state of health or controlled (health parameters within the normal range for their disease) chronic diseases that do not fall within the exclusion criteria. 4. Willingness to comply with study procedures. 5. No plans to move to another city in the next 6 months and willing to be contacted by the research team within the study period. 6. Not participate in another research study in the previous 3 months, nor plans to participate in another research study in the next 6 months. 7. Agrees to avoid elective surgery during the study. 8. Willingness to receive HIV test results. 9. Not having received a BCG vaccination within the last 10 years before study vaccination. Exlusion Criteria 1. Oral temperature ≥37.5°C, axillary ≥37.5°C or tympanic temperature ≥38.0°C in the last 24 hours. 2. Weight less than 50 kg, as well as BMI less than 18.5 or higher than 35 kg/m2. 3. History of treatment or current history of active or latent tuberculosis infection. 4. History of unprotected occupational exposure to an individual with active tuberculosis in a healthcare setting within the past 6 months. 5. Immunosuppressive drugs used within the previous 42 days (inhaled and topical corticosteroids are allowed). 6. Received documented investigational tuberculosis vaccine at any time. 7. Unstable hormonal status, i.e. subjects with any change (dose, formulation, or route) in hormone replacement therapies (including levothyroxine, insulin, estrogen, progesterone etc.) in the last 12 weeks. 8. History or laboratory evidence of any possible past, present, or future immunodeficiency status, including, but not limited to, any laboratory indication of HIV-1 infection. 9. Allergy to BCG vaccine or its components, as well as the existence of contraindications for BCG administration as described in the BCG prescribing information. 10. Previous medical history that may compromise the safety of the study participant, including but not limited to significant impairment of lung function (such as pulmonary diffusion of carbon dioxide \