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

NCT05021016 | Completed Phase 3

• 1 other identifier: COV/pept-02/20
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

Covid19; SARS-CoV-2; EpiVacCorona; vaccination

Outcome Measures

Primary Outcomes (1)

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

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

  21 days after the second vaccination dose

Secondary Outcomes (5)

• 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

Study Arms (1)

Group 1: "Vaccine"

EXPERIMENTAL

150 volunteers who will be vaccinated with the EpiVacCorona vaccine with two doses 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)

Interventions

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

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.

Group 1: "Vaccine"

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Persons in custody in detention facilities and those serving sentences in correctional facilities.
• History of any acute respiratory illness less than 3 months prior to randomization.
• Acute infectious or non-infectious diseases, exacerbation of chronic diseases less than 4 weeks prior to randomization.
• History of tuberculosis (pulmonary and extrapulmonary), cancer, autoimmune diseases, skin diseases (pemphigus, psoriasis, eczema, atopic dermatitis).
• Long-term use (more than 14 days) of immunosuppressants, systemic glucocorticosteroids or immunomodulatory drugs within 6 months prior to randomization.

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

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

Study Officials

• Vladimir I. Kuzubov, PhD

  FGBUZ MSCH-163, FMBA of Russia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: August 25, 2021
• Study Start: November 19, 2020
• Primary Completion: January 30, 2021
• Study Completion: January 30, 2021
• Last Updated: August 27, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)