NCT04527575

Study of the Safety, Reactogenicity and Immunogenicity of "EpiVacCorona" Vaccine for the Prevention of COVID-19

Simple, Blind, Placebo-controlled, Randomized Study of the Safety, Reactogenicity and Immunogenicity of Vaccine Based on Peptide Antigens for the Prevention of COVID-19 (EpiVacCorona), in Volunteers Aged 18-60 Years (I-II Phase)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector" · Other Government
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Covid19

Interventions

Type	Name	Description
BIOLOGICAL	EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19)	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.
OTHER	Placebo (sodium chloride bufus, solvent for the preparation of dosage forms for injection 0.9%)	The use of placebo: intramuscularly, twice, spaced 21 days apart, at a dose of 0.5 ml (43 volunteers)

Timeline

• Start date: 2020-07-27
• Primary completion: 2021-12-30
• Completion: 2021-12-30
• First posted: 2020-08-26
• Last updated: 2022-03-16

Locations

1 site across 1 country: Russia