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

NCT05021016 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-08-27

No results posted yet for this study

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.

Conditions

  • Covid19

Interventions

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.

Sponsors & Collaborators

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

    lead OTHER_GOV

Principal Investigators

  • Vladimir I. Kuzubov, PhD · FGBUZ MSCH-163, FMBA of Russia

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-19
Primary Completion
2021-01-30
Completion
2021-01-30

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05021016 on ClinicalTrials.gov