The vaccination study schedule included two intramuscular injections (0.5 mL each) within a 28-day interval.
Stage I: Group 1 (n = 10) received the vaccine at 20 μg of the active ingredient (first dose) and 5 μg (second dose). Group 2 (n = 10) received the vaccine at 20 μg (first dose) and 20 μg (second dose).
Stage II: Group 3 (n = 32) received the vaccine at 20 μg of the active ingredient (first dose) and 5 μg (second dose). Group 4 (n = 32) received the vaccine at 20 μg (first dose) and 20 μg (second dose). Group 5 (n = 32) received two 0.5 mL intramuscular placebo injections of 0.9% sodium chloride solution.
Participation of each volunteer in the study assumed Visit 0 (screening), Visits 1–4 and Visits 10–13 in an inpatient setting (in hospital), and Visits 5–9, 14–20 in an outpatient setting. Volunteers received the study drug (one of two doses) or placebo on Visits 2 and 11.
The study participants were monitored for the expected outcomes. The main safety and tolerability outcomes were centrally reviewed by the Independent Data Monitoring Committee (IDMC).
Total immunoglobulins were determined using the ELISA “SARS-CoV-2-CoronaPass test system” (Biopalitra, Moscow, Russia). The titer of total IgG was measured with chemiluminescent microparticle immunoassay (CMIA) “SARS-CoV-2 IgG II Quant assay” (Abbott Laboratories, Chicago, IL, USA). Neutralizing antibodies were measured by “SARS-CoV-2 Surrogate Virus Neutralization Test Kit” (GenScript, Piscataway, NJ, USA).
Stage I: Group 1 (n = 10) received the vaccine at 20 μg of the active ingredient (first dose) and 5 μg (second dose). Group 2 (n = 10) received the vaccine at 20 μg (first dose) and 20 μg (second dose).
Stage II: Group 3 (n = 32) received the vaccine at 20 μg of the active ingredient (first dose) and 5 μg (second dose). Group 4 (n = 32) received the vaccine at 20 μg (first dose) and 20 μg (second dose). Group 5 (n = 32) received two 0.5 mL intramuscular placebo injections of 0.9% sodium chloride solution.
Participation of each volunteer in the study assumed Visit 0 (screening), Visits 1–4 and Visits 10–13 in an inpatient setting (in hospital), and Visits 5–9, 14–20 in an outpatient setting. Volunteers received the study drug (one of two doses) or placebo on Visits 2 and 11.
The study participants were monitored for the expected outcomes. The main safety and tolerability outcomes were centrally reviewed by the Independent Data Monitoring Committee (IDMC).
Total immunoglobulins were determined using the ELISA “SARS-CoV-2-CoronaPass test system” (Biopalitra, Moscow, Russia). The titer of total IgG was measured with chemiluminescent microparticle immunoassay (CMIA) “SARS-CoV-2 IgG II Quant assay” (Abbott Laboratories, Chicago, IL, USA). Neutralizing antibodies were measured by “SARS-CoV-2 Surrogate Virus Neutralization Test Kit” (GenScript, Piscataway, NJ, USA).
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