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)

Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector"1 site in 1 country150 target enrollmentNovember 19, 2020

ConditionsCovid19

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Covid19
Sponsor: Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector"
Enrollment: 150
Locations: 1
Primary Endpoint: Geometric mean titer (GMT) of antibodies in virus neutralization reaction
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

November 19, 2020

End Date

January 30, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

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

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Availability of a signed and dated informed consent of the volunteer to participate in a clinical trial, prior to any of the study procedures.
•Volunteers (men and women) aged 60 and above with stable indicators of basic vital functions.
•Ability to attend all scheduled visits and all planned procedures and examinations.
•Postmenopausal women over 60 years old.

Exclusion Criteria

•History of severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS) or another coronavirus infection (HCoV-229E, HCOV-OC43, HCoV-NL63, HCoV-HKU1).
•History of exposure to confirmed or suspected cases of SARS-CoV-2 infection within 1 month prior to randomization.
•Positive for IgM or IgG to SARS-CoV-2 as detected during screening.
•Positive PCR test for SARS-CoV-2 as detected during screening.
•Clinically and laboratory (according to PCR data) confirmed disease caused by SARS-CoV-2 coronavirus, at the moment or in the past.
•Serious post-vaccination reaction (body temperature above 40 °C , hyperemia or edema greater than 8 cm in diameter) or complication (collapse or shock-like state that developed within 48 hours after vaccination; convulsions, with or without of a febrile state) to a previous vaccination in the past.
•Aggravated allergic history (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, atopy, history of serum disease, history of hypersensitivity or allergic reactions to the administration of any vaccines, any known allergic reactions to vaccine components, etc.).
•History of Guillain-Barré syndrome (acute polyradiculitis).
•Previous vaccination with rabies vaccines within less than 2 months prior to randomization, or planned vaccination with rabies vaccines within 1 month after immunization with the vaccine under study.
•Hypersensitivity to any component of the product, allergy to vaccine components.

Outcomes

Primary Outcomes

Geometric mean titer (GMT) of antibodies in virus neutralization reaction

Time Frame: 21 days after the second vaccination dose

Geometric mean titer (GMT) of antibodies on day 21 following the second vaccination dose (Visit 17) in virus neutralization reaction

Secondary Outcomes

Geometric mean titer (GMT) of specific antibodies in ELISA(21 days after the second vaccination dose)
Specific neutralizing antibody titers in ELISA(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(within 6 months following the first vaccination)
The proportion of volunteers with a T-cell response(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(within 6 months following the first vaccination)