2.2.2. Design and Participants in 60+ Age Cohort
SARS-CoV-2 infection, neutropenia, Guillain, cancer, autoimmune diseases, Barré syndrome, hyperthermia, anorexia
ACUTE RESPIRATORY DISEASE, SARS-COV-2 INFECTION, NEUTROPENIA, CANCER, AUTOIMMUNE DISEASES, CHRONIC DISEASES, TUBERCULOSIS, ANOREXIA, ALLERGIC REACTIONS
Safety and immunogenicity assessment of CoviVac in the 60+ age cohort was performed in an open multi-center phase IIb clinical trial.At initial screening, all participants in the 60+ age cohort were tested for SARS-CoV-2 infection via PCR using nasopharyngeal swabs. All participants were screened for eligibility on the basis of their health status, including their medical history, vital signs, physical examination and laboratory test results, and were enrolled after providing signed and dated informed consent forms.The study included healthy volunteers and volunteers who had a history of chronic diseases with a stable course, aged 60 years and older at the time of inclusion, males and females, who provided signed and dated informed consent form, were able to comply with the requirements of the study protocol (i.e., filling out self-observation diaries and coming to scheduled visits) and did not meet the study non-inclusion criteria. The non-inclusion criteria were PCR or ELISA-confirmed SARS-CoV-2 infection in the previous 6 months, other acute respiratory diseases in the previous 4 weeks, hyperthermia at the time of vaccination, neutropenia, severe and/or uncontrolled cardiovascular, bronchopulmonary, neuroendocrine, gastrointestinal, liver, kidney, hematopoietic, immune system diseases, medical history of serious allergic reactions, serious post-vaccination reactions, Guillain–Barré syndrome, tuberculosis, cancer, autoimmune diseases immunosuppressive conditions, recent large blood donations (450 mL or more), splenectomy and anorexia.Out of 230 screened volunteers, 200 were included, and 168 received all three doses of the vaccine and entered immunogenicity assessment 21 days after completing the vaccination course (