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

NCT04527575 | Completed Phase 1

• 1 other identifier: COV/pept-01/20
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Covid19; SARS-CoV-2; EpiVacCorona; vaccination

Outcome Measures

Primary Outcomes (1)

• The proportion of vaccinated volunteers with no laboratory confirmed symptoms caused by SARS-CoV-2 within 9 months post vaccination

  • The proportion of vaccinated volunteers with no laboratory confirmed symptoms caused by SARS-CoV-2, in combination with one or more of the following symptoms: fever or chills; cough; shortness of breath or labored breathing; fatigue; muscle pain; headache; The proportion of vaccinated volunteers with no laboratory confirmed symptoms caused loss of taste or smell; sore throat; a stuffy nose or runny nose; nausea or vomiting; diarrhea, within 9 months post vaccination versus a placebo.

  throughout the study, an average of 270 days

Secondary Outcomes (6)

• The proportion of volunteers with increased levels of the immune response in terms of geometric mean titers of specific antibodies in ELISA following the vaccination compared with a placebo.

  at days 0, 1, 14, 20, 35, 42, 90, 180, 270

• The proportion of volunteers with increased levels of the immune response in terms of specific neutralizing antibody titers in ELISA following the vaccination, compared with a placebo

  at days 0, 1, 14, 20, 35, 42, 90, 180, 270

• The proportion of volunteers with an ex vivo cellular immune response following the vaccination, compared with a placebo

  at days 0, 1, 14, 20, 35, 42, 90, 180, 270

• Incidence and type of adverse events during the study

  throughout the study, an average of 270 days

• Incidence of serious adverse events during the study

  throughout the study, an average of 270 days

Study Arms (3)

"EpiVacCorona" (An Open Study)

EXPERIMENTAL

Group 1: 14 volunteers who will be vaccinated with the EpiVacCorona vaccine twice spaced 21 days apart, intramuscularly, at a dose of 0.5 ml

Biological: EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19)

"EpiVacCorona" (A Simple, Blind, Randomized Study)

EXPERIMENTAL

Group 2: Administration of the EpiVacCorona vaccine, intramuscularly, twice, 21 days spaced apart, at a dose of 0.5 ml (43 volunteers)

Biological: EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19)

"Placebo" (A Simple, Blind, Randomized Study)

PLACEBO COMPARATOR

Group 3: Тhe use of placebo (sodium chloride, solvent for the preparation of dosage forms for injection 0.9%) intramuscularly twice space 21 days apart at a dose of 0.5 ml (43 volunteers)

Other: Placebo (sodium chloride bufus, solvent for the preparation of dosage forms for injection 0.9%)

Interventions

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

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.

"EpiVacCorona" (A Simple, Blind, Randomized Study); "EpiVacCorona" (An Open Study)

Placebo (sodium chloride bufus, solvent for the preparation of dosage forms for injection 0.9%) OTHER

The use of placebo: intramuscularly, twice, spaced 21 days apart, at a dose of 0.5 ml (43 volunteers)

"Placebo" (A Simple, Blind, Randomized Study)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• Contacts with COVID-19 patients for 14 days prior to the start of the clinical trial.
• Hypersensitivity to any component of the product, allergy to the components of the vaccine.
• The history of allergic reactions to any vaccination in the past.
• Serious post-vaccination reactions/complications associated with any vaccination in the past.
• Pregnancy and breastfeeding.
• Military personnel on conscription.
• Persons detained in pre-trial detention facilities and those serving sentences in prison.
• Children under the age of 18.
• The history of acute infectious or non-communicable diseases, exacerbation of chronic diseases within less than 4 weeks before the start of the study.
• The history of tuberculosis (pulmonary and extrapulmonary), cancer, autoimmune diseases, skin diseases (pemphigus, psoriasis, eczema, atopic dermatitis).
• Long-term use (more than 14 days) of immunosuppressive drug, systemic glucocorticosteroids or immunomodulatory drugs within 6 months prior to the study.
• Vaccination with any vaccine within one month prior to vaccination.
• Taking immunoglobulin drugs or blood products within last 3 months prior to the study.
• The history of treatment with human immunoglobulin drugs within, less than 6 months since such treatment.
• Donation (450 ml of blood or plasma and more) within less than 2 months prior to the study.

Sponsors & Collaborators

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

Study Sites (1)

Federal State Budgetary Institution of Healthcare "Medical and Sanitary Unit No. 163 of the Federal Medical and Biological Agency" (FGBUZ MSCH-163, FMBA of Russia)

Kol'tsovo, Novosibirsk Oblast, 630559, Russia

Location

MeSH Terms

Conditions

COVID-19

Interventions

EpiVacCorona vaccine; Solvents

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specialty Uses of Chemicals; Chemical Actions and Uses

Study Officials

• Vladimir I. Kuzubov

  FGBUZ MSCH-163, FMBA of Russia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Masking in Phase 2
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Simple, blind, placebo-controlled, randomized study involving healthy volunteers

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 26, 2020
• Study Start: July 27, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)