2.2.1. Design and Participants in 18–60 Age Cohort
cancer, autoimmune diseases, SARS-CoV-2 infection, MERS infection
SARS-COV-2 INFECTION, CANCER, AUTOIMMUNE DISEASES, TUBERCULOSIS, CORONAVIRUS, ALLERGIC REACTIONS
A randomized, double-blind, placebo-controlled, multi-center clinical trial of the tolerability, safety, and immunogenicity of the inactivated whole virion concentrated purified coronavirus vaccine CoviVac was performed in adult volunteers aged 18–60 years.Studies in 18–60 age cohort were performed in 3 consequent Stages: Stage 1 included the first 15 volunteers (10 inoculated with the vaccine and 5 with placebo twice with 14 days interval, on days 0 and 14); Stage 2 included 185 participants (140 inoculated with the vaccine and 45 with placebo twice with 14 days interval) and started after the post-vaccination observation period in Stage 1; Stage 3 included 200 participants (150 inoculated with the vaccine and 50 with placebo twice with 14 days interval) (During initial screening, all participants in the 18–60 age cohort were tested for SARS-CoV-2 infection by PCR in nasopharyngeal swabs. The participants of Stages 1 and 2 were also screened at enrolment for anti-SARS-CoV-2 IgM and IgG antibodies by ELISA. Individuals positive in either test were not included. The participants of Stage 3 were included regardless of their SARS-CoV-2 IgM and IgG status at enrolment. Individuals with a history of SARS-CoV-1, SARS-CoV-2, or MERS infection, confirmed contact with COVID-19 patients, previous severe allergic reactions, tuberculosis, cancer, and mental or autoimmune diseases were also not included. 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. Detailed study protocol can be found at 