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

NCT04527575 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-03-16

No results posted yet for this study

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.

Conditions

  • Covid19

Interventions

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)

Sponsors & Collaborators

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

    lead OTHER_GOV

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-27
Primary Completion
2021-12-30
Completion
2021-12-30

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 NCT04527575 on ClinicalTrials.gov