Prevention Of Respiratory Tract Infection And Covid-19 Through BCG Vaccination In Vulnerable Older Adults

Exclusion Criteria

• •Fever (\>38 ºC) within the past 24 hours
• •Suspicion of current active viral or bacterial infection; the requirement to finish an antibiotic course upon discharge is not an exclusion criterion when the infection is controlled in the opinion of the attending physician
• •Vaccination with live vaccine in the past four weeks or planned vaccination with live vaccine during the next four weeks
• •Severely immunocompromised participants. This exclusion category comprises:
• •1. known infection by the human immunodeficiency virus (HIV-1);
• •2. neutropenic with less than 500 neutrophils/mm3;
• •3. solid organ transplantation;
• •4. bone marrow transplantation;
• •5. hematological malignancy;
• •6. chemo-, radio- or immunotherapy for solid organ malignancy in the past 6 months;
• •7. primary immunodeficiency;
• •8. severe lymphopenia with less than 400 lymphocytes/mm3;
• •9. treatment with any immunosuppressant drugs such as anti-cytokine therapies, and treatment with oral or intravenous steroids defined as daily doses of \>10 mg/day or a cumulative dose of \>700 mg prednisone or equivalent for other corticosteroids, or probable use of oral or intravenous steroids in the following four weeks
• •Known history of a positive Mantoux or active TB; prior BCG vaccination is NOT an exclusion criterion.
• •Born in a country with high incidence of TB; a list of non-eligible countries will be created by the trial steering committee prior to the first enrolment.
• •Active participation in another research study that involves BCG administration
• •History of documented COVID-19 (self-reported by the participant: either confirmed by a microbiological test or with clinical diagnosis during hospitalization)
• •Not able to perform the study procedures as judged by the attending physician
• •Legally incapacitated or unwilling to provide informed consent