NCT05021016

Study of the EpiVacCorona Vaccine With the Involvement of Volunteers Aged 60 Years and Above

An Open Study of the Safety, Reactogenicity and Immunogenicity of the Vaccine Based on Peptide Antigens for the Prevention of COVID-19 (EpiVacCorona), With the Involvement of Volunteers Aged 60 Years and Above (Phase III-IV)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector" · Other Government
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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).

Conditions

• Covid19

Interventions

Type	Name	Description
BIOLOGICAL	EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19)	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.

Timeline

• Start date: 2020-11-19
• Primary completion: 2021-01-30
• Completion: 2021-01-30
• First posted: 2021-08-25
• Last updated: 2021-08-27

Locations

1 site across 1 country: Russia