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

Inclusion criteria

• Has completed the written informed consent process.
• Males or females, over 60 years of age as of the date of signature of the informed consent form.
• 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.
• Willingness to comply with study procedures.
• 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.
• Not participate in another research study in the previous 3 months, nor plans to participate in another research study in the next 6 months.
• Agrees to avoid elective surgery during the study.
• Willingness to receive HIV test results.
• Not having received a BCG vaccination within the last 10 years before study vaccination.

Exlusion Criteria

• Oral temperature ≥37.5°C, axillary ≥37.5°C or tympanic temperature ≥38.0°C in the last 24 hours.
• Weight less than 50 kg, as well as BMI less than 18.5 or higher than 35 kg/m2.
• History of treatment or current history of active or latent tuberculosis infection.
• History of unprotected occupational exposure to an individual with active tuberculosis in a healthcare setting within the past 6 months.
• Immunosuppressive drugs used within the previous 42 days (inhaled and topical corticosteroids are allowed).
• Received documented investigational tuberculosis vaccine at any time.
• 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.
• 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.
• Allergy to BCG vaccine or its components, as well as the existence of contraindications for BCG administration as described in the BCG prescribing information.
• 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 <80% or FEV1 ≤80%) due to tuberculosis infection or other pulmonary disease; chronic heart disease with signs of heart failure (NYHA Class II Heart Failure or more) or coronary heart disease, suspicion of progressive neurological disease; uncontrolled epilepsy, liver disease.
• Administration of attenuated vaccines within 30 days before the start of the study or 14 days for inactivated ones.
• Having received transfusions or blood products within the 6 months before the start of the study.
• Uncontrolled hypertension or systolic blood pressure greater than 160 mmHg at the beginning of the study or diastolic greater than 90 mmHg.
• Active neoplasia.
• Stage 2 or higher chronic obstructive pulmonary disease.
• Chronic bronchial asthma with systemic corticosteroids, or with a history of having presented crises that have led to an emergency consultation within the last 2 months.
• Renal disease with estimated or relative creatinine clearance ≤ 70 ml/min x 1.73 m2.
• Evidence of a new acute illness that may compromise the safety of the study participant, such as fever (oral or axillary temperature greater than or equal to 37.5°C) or suspicion of active infection.
• History or laboratory evidence of chronic viral hepatitis.
• History of alcohol or drug abuse in the last 2 years.
• Smoking more than 30 cigarettes a day, or cannabis use three or more days a week.
• History of keloid formation.
• Congenital diseases of importance, such that they weaken the basal condition of the volunteer.
• Congenital or acquired absence of the spleen.
• Coagulation disorders or known thrombocytopenia of less than 100,000 platelets/mm3.
• Having undergone chemotherapy treatment in the last 6 months.
• Generalized urticaria in the last 2 months.
• History of hereditary or acquired angioneurotic edema.
• Any previous medical condition that the investigator considers may compromise the safety of the subject in the study.
• Not being available for all study visits (both face-to-face and by telephone) and specific instructions as appropriate (fasting, abstaining from intense physical exercise during the 24 hours before the study visits and during the 72 hours after vaccination).
• Pregnant women or women of childbearing potential (WOCBP) who are unable or unwilling to utilize appropriate methods of contraception during the study.
• Breast-feeding women.
• Male with heterosexual sexual activity with WOCBP who do not agree to use adequate contraception.