An Open Comparative Study of the Effectiveness and Incomparable Study of the Immunogenicity and Safety of the Vaccine (CoviVac) for Adults Aged 60 Years and Older

NCT05765773 | Completed Phase 2 DMC

• 1 other identifier: № VKI-P-II-07/21
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 7

Brief Summary

An Open Comprative Study of the Prophylactic Efficacy and a Non-comparative Study of the Immunogenicity and Safety of the Inactivated Whole-virion Concentrated Purified Coronavirus Vaccine (CoviVac) Produced by FSBSI "Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products" for Adults Aged 60 Years and Older

Conditions

Vaccine; Corona Virus Infection; COVID-19

Keywords

COVID-19; SARS-Cov-2

Outcome Measures

Primary Outcomes (4)

• Frequency of development, type and association with vaccination of adverse events during the study.

  Frequency of development, type and association with vaccination of adverse events during the study.

  6 month

• Titer of specific antibodies

  The proportion of volunteers from the total number of vaccinated with the level of seroconversion (titer of specific antibodies = 4 times the baseline level) on 21 days after the course of vaccination in the reaction of viral neutralization and / or ELISA.

  21 days

• GMT on day 21 after the course of vaccination

  The proportion of volunteers with an increase in the level of immune response in the form of geometric mean titers of specific antibodies (GMT) on day 21 after the course of vaccination in the reaction of viral neutralization and / or ELISA.

  21 days

• The frequency of occurrence of clinically significant deviations from the norm of the main indicators of vital functions and laboratory parameters.

  The frequency of occurrence of clinically significant deviations from the norm of the main indicators of vital functions and laboratory parameters.

  6 month

Secondary Outcomes (1)

• ARVI, COVID-19

  6 month

Study Arms (2)

The study group consisted of 200 volunteers

EXPERIMENTAL

The study group is planned to screen a maximum of 250 volunteers inclusive, of which it is planned to include 200 men and women aged 60 years and older who meet the criteria for inclusion in the study and do not have non-inclusion criteria.

Biological: CoviVac vaccine (inactivated whole-virion concentrated purified) manufactured by FSBSI "Chumakov FSC R&D IBP RAS"

Control group

NO INTERVENTION

Retrospective immunogenicity data obtained in the framework of clinical study № VKI-I/II-08/20 on healthy volunteers aged 18-60 years.

Interventions

CoviVac vaccine (inactivated whole-virion concentrated purified) manufactured by FSBSI "Chumakov FSC R&D IBP RAS" BIOLOGICAL

200 volunteers who will be vaccinated with the CoviVac vaccine three times with an interval of 21 days intramuscularly at a dose of 0.5 ml.

The study group consisted of 200 volunteers

Eligibility Criteria

• Age: 60 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type of participants
• Written informed consent of volunteers to participate in a clinical trial
• Volunteers who are able to fulfill the Protocol requirements (i.e., fill out a self-observation Diary, come to control visits).

You may not qualify if:

• SARS-CoV-2 infection • A case of established COVID-19 disease confirmed by PCR and/or ELISA in the last 6 months.
• Diseases or medical conditions
• Serious post-vaccination reaction (temperature above 40 C, hyperemia or edema more than 8 cm in diameter) or complication (collapse or shock-like condition that developed within 48 hours after vaccination; convulsions, accompanied or not accompanied by a feverish state) to any previous vaccination.
• Burdened allergic history (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, serum sickness in the anamnesis, hypersensitivity or allergic reactions to the introduction of any vaccines in the anamnesis, known allergic reactions to vaccine components, etc.).
• Guillain-Barre syndrome (acute polyradiculitis) in the anamnesis.
• The axillary temperature at the time of vaccination is more than 37.0 ° C.
• Acute infectious diseases (recovery earlier than 4 weeks before vaccination) according to anamnesis.
• Severe and/or uncontrolled diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, gastrointestinal tract, liver, kidneys, hematopoietic, immune systems.
• Is registered at the dispensary for tuberculosis, leukemia, oncological diseases, autoimmune diseases.
• Any confirmed or suspected immunosuppressive or immunodeficiency condition in the anamnesis.
• Splenectomy in the anamnesis.
• Neutropenia (decrease in the absolute number of neutrophils less than 1000/mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin less than 80 g/l) according to anamnesis.
• Anorexia according to anamnesis.
• Prior or concomitant therapy
• Vaccination with any vaccine carried out within 30 days before vaccination / the first dose of the studied vaccine or planned administration within 30 days after vaccination / the last dose of the studied vaccine.

Sponsors & Collaborators

• Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products: lead

Study Sites (7)

Federal State Budgetary Scientific Institution "I.I. Mechnikov Scientific Research Institute of Vaccines and Serums"

Moscow, Moscow, 105064, Russia

Location

FSBSI Chumakov FSC R&D IBP RAS

Moscow, Moscow, 108819, Russia

Location

Private healthcare institution "Clinical Hospital "Russian Railways-Medicine" named after N.A. Semashko"

Moscow, Moscow, 109386, Russia

Location

Limited Liability Company "Scientific Research Center Ecosecurity"

Moscow, Moscow, 196143, Russia

Location

State Budgetary Healthcare Institution of the Moscow region "Elektrostal Central City Hospital"

Elektrostal, Moscow Oblast, 144000, Russia

Location

Federal State Budgetary Healthcare Institution "Medical and Sanitary Unit No. 163 of the Federal Medical and Biological Agency"

Novosibirsk, Novosibirsk Oblast, 630559, Russia

Location

Federal State Budgetary Educational Institution of Higher Education "Perm State Medical University named after Academician E.A. Wagner" of the Ministry of Health of the Russian Federation

Perm, Perm Krai, 614990, Russia

Location

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: March 13, 2023
• Study Start: July 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: May 19, 2023
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

RU (7)