Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector"

The Aim:
Study immunogenicity, confirm the safety and tolerability of different schedules of vaccination with "live cell-based vaccine against smallpox and other orthopoxvirus infections (VAC∆6 vaccine) based on vaccinia virus" using a complex of clinical and laboratory-instrumental techniques.
The research tasks are to:
To study the immunological activity of a single VAC∆6 vaccine dose of 1x10⁷ plaque-forming units (PFU).
To study the immunological activity of two VAC∆6 vaccine doses (given 28 days apart) of 1x10⁶ PFU.
Assess the safety of different VAC∆6 vaccination schedules using a set of clinical and laboratory-instrumental techniques (thermometry, measurement of blood pressure, heart and lung auscultation, ECG, common blood and urine tests, biochemical, immunological and virological studies).
Assess the reactogenicity of different VAC∆6 vaccination schedules (number of local and systemic reactions, the percentage of those vaccinated with systemic and local reactions of various severity degrees).
To identify VAC∆6 vaccine-associated adverse events.
Study cell-mediated immunity induced by different VAC∆6 vaccination schedules.
Determine the presence of the virus in specific skin formations (crusts, pustules), saliva, blood and urine.
Evaluate the protective efficacy of one and two doses of the studied VAC∆6 vaccine.

The objective of the clinical study is to evaluate the tolerability, safety, immunogenicity and prophylactic efficacy of the EpiVacCorona vaccine in volunteers aged 18 and above.
The study tasks are to:
evaluate the safety of the EpiVacCorona vaccine when administered twice intramuscularly;
evaluate the tolerability of the EpiVacCorona vaccine when administered twice intramuscularly;
identify any adverse events to the administration of the EpiVacCorona vaccine;
investigate the humoral immune response following two doses of the EpiVacCorona vaccine;
investigate the cell-mediated immune response following two doses of the EpiVacCorona vaccine;
evaluate the prophylactic efficacy of the EpiVacCorona vaccine when administered twice intramuscularly.

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.