Corona Virus InfectionPhase 2NCT05765773

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

A Phase 2 study testing CoviVac vaccine (inactivated whole-virion concentrated purified) manufactured by FSBSI "Chumakov FSC R&D IBP RAS" in people with Corona Virus Infection and Vaccine, run by Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products at 7 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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"… Read more about this study

Who is it for?: Ages 60 to 99 yearsHealthy volunteers can take part
Conditions the study is for: Corona Virus Infection, Vaccine, COVID-19
What is being tested?: CoviVac vaccine (inactivated whole-virion concentrated purified) manufactured by FSBSI "Chumakov FSC R&D IBP RAS"
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 7 sitesRussia
Study dates: 1 Jul 2021to 19 May 2023
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 to 99 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Volunteers must meet the following inclusion criteria:
Type of participants
Healthy volunteers or volunteers with a history of stable diseases that do not meet any of the criteria for non-inclusion in the study.
Other inclusion criteria
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).

Who cannot join

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.

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Acute infectious diseases (recovery earlier than 4 weeks before vaccination) according to anamnesis.
Donation of blood or plasma (in the amount of 450 ml or more) less than 2 months before inclusion in the study.
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.
Prior vaccination with an experimental or registered vaccine that may affect the interpretation of the study data (any coronavirus or SARS vaccines).
Long-term use (more than 14 days) of immunosuppressants or other immunomodulatory drugs (immunoregulatory peptides, cytokines, interferons, immune system effector proteins (immunoglobulins), interferon inducers (cycloferon) during the six months preceding the study, according to anamnesis.
Treatment with systemic glucocorticosteroids (≥ 20 mg of prednisone, or an analog, for more than 15 days during the last month).
Volunteers who received immunoglobulin preparations or blood transfusion during the last 3 months prior to the start of the study according to anamnesis.
Other non-inclusion criteria
Participation in any other clinical trial within the last 3 months.
Withdrawal of Informed consent by a volunteer;
The volunteer was included in violation of the inclusion/non-inclusion criteria of the Protocol;
Any condition of a volunteer that requires, in the reasoned opinion of a medical researcher, the withdrawal of a volunteer from the study;
Taking unauthorized medications (see section 6.2);
The volunteer refuses to cooperate or is undisciplined (for example, failure to attend a scheduled visit without warning the researcher and/or loss of communication with the volunteer), or dropped out of observation;
For administrative reasons (termination of the study by the Sponsor or regulatory authorities), as well as in case of gross violations of the Protocol that may affect the results of the study.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

Russia7 sites

State Budgetary Healthcare Institution of the Moscow region "Elektrostal Central City Hospital"
Elektrostal, Moscow Oblast, 144000
Federal State Budgetary Scientific Institution "I.I. Mechnikov Scientific Research Institute of Vaccines and Serums"
Moscow, Moscow, 105064
FSBSI Chumakov FSC R&D IBP RAS
Moscow, Moscow, 108819
Private healthcare institution "Clinical Hospital "Russian Railways-Medicine" named after N.A. Semashko"
Moscow, Moscow, 109386
Limited Liability Company "Scientific Research Center Ecosecurity"
Moscow, Moscow, 196143
Federal State Budgetary Healthcare Institution "Medical and Sanitary Unit No. 163 of the Federal Medical and Biological Agency"
Novosibirsk, Novosibirsk Oblast, 630559
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

Other trials in Russia

About this study

Official title: 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) for Adults Aged 60 Years and Older

Read the detailed description

An open comparative multicenter prospective study with retrospective data.

Conditions: Corona Virus Infection, Vaccine, COVID-19
Being tested: CoviVac vaccine (inactivated whole-virion concentrated purified) manufactured by FSBSI "Chumakov FSC R&D IBP RAS"
Keywords: COVID-19, SARS-Cov-2
Medical subject headings: Coronavirus Infections, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT05765773
Study group	Role	What they receive
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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 month

Secondary outcomes (1)

ARVI, COVID-19
Frequency, severity and duration of incidence of Acute respiratory diseases (ARVI, COVID-19) within six months after triple vaccination.
Measured: 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 202119 May 2023

First posted13 Mar 2023
Study start1 Jul 2021
Primary completion1 Oct 2022
Study completion19 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Corona Virus InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05765773
Sponsor's protocol ID: № VKI-P-II-07/21
Status last verified: Mar 2026
First submitted: 13 Feb 2023
Last updated: 19 Mar 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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) for Adults Aged 60 Years and Older
ClinicalTrials.gov ID: NCT05765773
Acronym / sponsor ID: № VKI-P-II-07/21
Conditions: Corona Virus Infection, Vaccine, COVID-19
Keywords: COVID-19, SARS-Cov-2
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological ProductsOther government
Study start: 1 Jul 2021 (actual)
Primary completion: 1 Oct 2022 (actual)
Study completion: 19 May 2023 (actual)
First posted: 13 Mar 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

An open comparative multicenter prospective study with retrospective data.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
The study group consisted of 200 volunteers	Experimental	Biological: CoviVac vaccine (inactivated whole-virion concentrated purified) manufactured by FSBSI "Chumakov FSC R&D IBP RAS"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.
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.

Who may qualify

Ages: 60 to 99 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Type of participants
Healthy volunteers or volunteers with a history of stable diseases that do not meet any of the criteria for non-inclusion in the study.
Other inclusion criteria
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).

Key exclusion criteria (28 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CoviVac vaccine (inactivated whole-virion concentrated purified) manufactured by FSBSI "Chumakov FSC R&D IBP RAS"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.	Biological	The study group consisted of 200 volunteers

Primary outcome

Frequency of development, type and association with vaccination of adverse events during the study.
Time frame: 6 month
Frequency of development, type and association with vaccination of adverse events during the study.
Titer of specific antibodies
Time frame: 21 days
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.
GMT on day 21 after the course of vaccination
Time frame: 21 days
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.
The frequency of occurrence of clinically significant deviations from the norm of the main indicators of vital functions and laboratory parameters.
Time frame: 6 month
The frequency of occurrence of clinically significant deviations from the norm of the main indicators of vital functions and laboratory parameters.

1 secondary outcome

ARVI, COVID-19
Time frame: 6 month

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of development, type and association with vaccination of adverse events during the study. (time frame: 6 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05765773.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026; AzTrials last refreshed its copy on 28 Oct 2026.