Completed

Inactivated Whole-virion Concentrated Purified Coronavirus Vaccine (CoviVac) Safety and Efficacy in Adults Aged 60 and Older

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Study Aim

This phase 2 study aims to evaluate the safety and effectiveness of CoviVac, an inactivated whole-virion concentrated purified coronavirus vaccine, in adults aged 60 and older, by monitoring the frequency of adverse events, the level of immune response, and the presence of clinically significant deviations from the norm in vital functions and laboratory parameters.

What is being tested

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

Biological
Who is being recruted

COVID-19+9

+ Coronaviridae Infections

+ Infections

From 60 to 99 Years
+22 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 2
Interventional
Study Start: July 2021
See protocol details

Summary

Principal SponsorChumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products
Last updated: March 20, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2021

Actual date on which the first participant was enrolled.

This study focuses on the prevention of coronavirus in adults aged 60 years and older. It aims to compare the effectiveness and safety of an inactivated whole-virion concentrated purified coronavirus vaccine called CoviVac. The study is important as it targets an age group that is more vulnerable to severe COVID-19 symptoms, and its potential outcomes could improve care and address current challenges in managing the pandemic. During this study, participants will receive the CoviVac vaccine. The study will monitor the frequency and type of adverse events associated with vaccination, as well as any significant deviations from normal vital functions and laboratory parameters. The immune response to the vaccine will be measured by looking at the geometric mean titers of specific antibodies and the proportion of participants showing seroconversion (a significant increase in antibody levels) 21 days after vaccination. The study will also evaluate the safety of the vaccine by tracking any adverse events that occur during the study period.

Official TitleAn 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) for Adults Aged 60 Years and Older
NCT05765773
Principal SponsorChumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products
Last updated: March 20, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

200 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 60 to 99 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

COVID-19Coronaviridae InfectionsInfectionsLung DiseasesPneumoniaPneumonia, ViralRespiratory Tract DiseasesRespiratory Tract InfectionsRNA Virus InfectionsVirus DiseasesCoronavirus InfectionsNidovirales Infections

Criteria

3 inclusion criteria required to participate
Healthy volunteers or volunteers with a history of stable diseases that do not meet any of the criteria for non-inclusion in the study
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)
19 exclusion criteria prevent from participating
A case of established COVID-19 disease confirmed by PCR and/or ELISA in the last 6 months
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Suspended

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

Moscow, RussiaOpen Federal State Budgetary Scientific Institution "I.I. Mechnikov Scientific Research Institute of Vaccines and Serums" in Google Maps
Suspended

FSBSI Chumakov FSC R&D IBP RAS

Moscow, Russia
Suspended

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

Moscow, Russia
Suspended

Limited Liability Company "Scientific Research Center Ecosecurity"

Moscow, Russia
Completed7 Study Centers