The aim of the clinical study is to study the safety, reactogenicity and immunogenicity indicators of the EpiVacCorona vaccine, with the involvement of volunteers aged 60 years and above. The research tasks are to: * to evaluate the safety of the EpiVacCorona vaccine when administered twice intramuscularly, with the participation of volunteers aged 60 years and older; * to evaluate the reactogenicity of the EpiVacCorona vaccine when administered twice intramuscularly, with the participation of volunteers aged 60 years and older; * to identify any adverse effects to the administration of the vaccine; * to study the humoral and cellular immune responses response following two doses of the EpiVacCorona vaccine, with the participation of volunteers aged 60 and older.
The study will screen a maximum of 180 volunteers, of which it is proposed to include and randomize 150 men and women aged 60 years and older who meet the inclusion criteria and who do not have the exclusion criteria whose data will be used for subsequent safety and immunogenicity analysis. The 150 volunteers will be vaccinated with the EpiVacCorona vaccine with two doses spaced 21 days apart, intramuscularly, at a dose of 0.5 ml. The vaccine will be administered in procedure room settings only by a highly qualified specialist (vaccinator).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
150
The 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 vaccine induces the specific immunity against the SARS-CoV-2 coronavirus following two intramuscular injections spaced 21 to 28 days apart. The EpiVacCorona vaccine contributes to the development of protective immunity against SARS-CoV-2 coronavirus following two intramuscular administrations given 21 to 28 days apart.
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
Geometric mean titer (GMT) of antibodies in virus neutralization reaction
Geometric mean titer (GMT) of antibodies on day 21 following the second vaccination dose (Visit 17) in virus neutralization reaction
Time frame: 21 days after the second vaccination dose
Geometric mean titer (GMT) of specific antibodies in ELISA
The proportion of volunteers with increased levels of the immune response in terms of geometric mean titers of specific antibodies in ELISA is more than 4 times greater 21 days following the second vaccination dose
Time frame: 21 days after the second vaccination dose
Specific neutralizing antibody titers in ELISA
The proportion of volunteers with increased levels of the immune response in terms of specific neutralizing antibody titers in ELISA is more than 4 times greater 21 days following the second vaccination
Time frame: 21 days after the second vaccination dose
The proportion of vaccinated volunteers with laboratory-confirmed SARS-CoV-2 symptoms in combination with one or more of the selected symptomsoV-2 symptoms in combination with one or more of the following symptoms
The proportion of vaccinated volunteers with laboratory-confirmed SARS-CoV-2 symptoms in combination with one or more of the following symptoms: fever or chills; cough; labored breathing or shortness of breath; fatigue; muscle pain; headache; loss of taste or smell; sore throat; nasal congestion or runny nose; nausea or vomiting; diarrhea within 6 months following vaccination
Time frame: within 6 months following the first vaccination
The proportion of volunteers with a T-cell response
The proportion of volunteers with a T-cell response (CD4 +, CD8 +, CD4 + / CD8 +, concentration of interferon gamma, IL-2, IL-4) 21 days following the second vaccination dose
Time frame: 21 days after the second vaccination dose
Geometric mean titers (GMT) of antibodies in the volunteers following vaccination and those in the convalescent volunteers vaccinated with the vaccine that recovered from COVID-19
Geometric mean titers (GMT) of antibodies in the volunteers following vaccination and those in the convalescent volunteers vaccinated with the vaccine that recovered from COVID-19 of varying severity
Time frame: within 6 months following the first vaccination
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