The aim of the clinical study is to determine the safety, reactogenicity and immunogenicity parameters of the EpiVacCorona vaccine in volunteers aged 18-60 years. The research tasks are to: * evaluate the safety of the EpiVacCorona vaccine when administered twice intramuscularly; * evaluate the reactogenicity of the EpiVacCorona vaccine when administered twice intramuscularly; * identify the development of adverse reactions to vaccine administration; * study the humoral and cellular immune responses following two doses of the EpiVacCorona vaccine.
The first phase of the clinical trial is an open trial. The study will enroll 14 men and women aged 18 to 30 years, inclusive, who meet the inclusion criteria and have no exclusion criteria, whose data will be used for subsequent analysis of safety and immunogenicity. The second phase of the clinical trial is a simple, blind, placebo-controlled, randomized, parallel-group study. The study will enroll 86 men and women aged 18 to 60 years, inclusive, who meet the inclusion criteria and have no exclusion criteria whose, the data will be used for subsequent analysis of safety and immunogenicity. If volunteers drop out of the study, they will not be replaced.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
100
EpiVacCorona vaccine is intended to prevent COVID-19. The vaccine relies on chemically synthesized peptide antigens of SARS-CoV-2 proteins, conjugated to a carrier protein and adsorbed on an aluminum-containing adjuvant (aluminum hydroxide). The EpiVacCorona vaccine contributes to the development of protective immunity against SARS-CoV-2 coronavirus following two intramuscular administrations spaced 21-28 days apart.
The use of placebo: intramuscularly, twice, spaced 21 days apart, at a dose of 0.5 ml (43 volunteers)
Federal State Budgetary Institution of Healthcare "Medical and Sanitary Unit No. 163 of the Federal Medical and Biological Agency" (FGBUZ MSCH-163, FMBA of Russia)
Kol'tsovo, Novosibirsk Oblast, Russia
The proportion of vaccinated volunteers with no laboratory confirmed symptoms caused by SARS-CoV-2 within 9 months post vaccination
• The proportion of vaccinated volunteers with no laboratory confirmed symptoms caused by SARS-CoV-2, in combination with one or more of the following symptoms: fever or chills; cough; shortness of breath or labored breathing; fatigue; muscle pain; headache; The proportion of vaccinated volunteers with no laboratory confirmed symptoms caused loss of taste or smell; sore throat; a stuffy nose or runny nose; nausea or vomiting; diarrhea, within 9 months post vaccination versus a placebo.
Time frame: throughout the study, an average of 270 days
The proportion of volunteers with increased levels of the immune response in terms of geometric mean titers of specific antibodies in ELISA following the vaccination compared with a placebo.
• The proportion of volunteers with increased levels of the immune response in terms of geometric mean titers of specific antibodies in ELISA greater ≥ 4 times 21 days following the second vaccination and 90, 180 and 270 days following the first vaccination compared with a placebo.
Time frame: at days 0, 1, 14, 20, 35, 42, 90, 180, 270
The proportion of volunteers with increased levels of the immune response in terms of specific neutralizing antibody titers in ELISA following the vaccination, compared with a placebo
• The proportion of volunteers with increased levels of the immune response in terms of specific neutralizing antibody titers in ELISA greater than ≥ 4 times 21 days following the second vaccination and 90, 180 and 270 days following the first vaccination, compared with a placebo.
Time frame: at days 0, 1, 14, 20, 35, 42, 90, 180, 270
The proportion of volunteers with an ex vivo cellular immune response following the vaccination, compared with a placebo
• The proportion of volunteers with an ex vivo cellular immune response 21 days following the second vaccination and 90, 180 and 270 days following the first vaccination, compared with a placebo.
Time frame: at days 0, 1, 14, 20, 35, 42, 90, 180, 270
Incidence and type of adverse events during the study
• Immediate adverse events (allergic reactions) that occur within 2 hours after vaccination and that are identified both by the clinical investigator and based on information provided by the volunteer; * adverse events (local and systemic reactions) that occur within 7 days after vaccination and that are identified both by the clinical investigator and based on information provided by the volunteer; * other adverse events that occur 7 days after each vaccination (from 8 to 42 days after the first vaccination, excluding the allowable interval of visits) and noted by the volunteer in the Self-observation Diary.
Time frame: throughout the study, an average of 270 days
Incidence of serious adverse events during the study
• Incidence of serious adverse events during the study.
Time frame: throughout the study, an average of 270 days
Cases of early termination of the study due to the development of adverse events / sever adverse events
• Cases of early termination of participation of volunteers in the study due to the development of adverse events / sever adverse events associated with the use of products under study.
Time frame: throughout the study, an average of 270 days
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