COVID-19Phase 3NCT06068569

Study of the Vector Vaccine GamCovidVac for the Prevention of COVID-19 With Altered Antigenic Profile With Participation of Adult Volunteers

A Phase 3 study testing GamCovidVac vector vaccine for the prevention of COVID-19 (with altered antigenic profile) in people with COVID-19, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Safety, reactogenicity and immunogenicity study of the vector vaccine GamCovidVac for the prevention of coronavirus (COVID-19) infection caused by the SARS-CoV-2 virus with altered antigenic profile with participation of adult volunteers Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: GamCovidVac vector vaccine for the prevention of COVID-19 (with altered antigenic profile)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: No sites listed yet
Study dates: Oct 2023to Dec 2024
Phase: Phase 3
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

The study will include volunteers who meet all the specified criteria:
Written informed consents to participate in the Study;
Adult volunteers men and women over 18 years old;
A negative test result for COVID-19, determined by PCR or express method before the introduction of the investigational medicinal product (IMP);
Consent to the use of effective methods of contraception during the entire period of participation in the Study;
A negative pregnancy test based on the results of a urine test at a screening visit (for women with preserved reproductive potential);

Show all 11Show fewer

Negative test for the presence of narcotic and psychostimulants in the urine at the screening visit;
Negative alcohol content test at the screening visit;
Any vaccination not earlier than the last 30 days before inclusion in the Study;
No contraindications to vaccination;
Absence of acute infectious and/or respiratory diseases for at least 14 days prior to inclusion in the Study.

Who cannot join

Volunteers cannot be included in the Study if there is at least one of the following criteria for non-inclusion:
No written informed consents to participate in the Study
Therapy with steroids (with the exception of hormonal contraceptives and/or hormone replacement therapy) and / or immunoglobulins or other blood products that did not end 30 days before inclusion in the Study;
Therapy with any immunosuppressive drugs completed less than 3 months prior to inclusion in the Study;
Female volunteers during pregnancy or lactation;
Acute coronary syndrome or stroke suffered less than one year prior to inclusion in the Study;

Show all 22Show fewer

Tuberculosis, chronic systemic infections (according to anamnesis);
Burdened allergic anamnesis (record of anaphylactic shock, Quincke's edema, polymorphic exudative eczema, serum sickness in the anamnesis), hypersensitivity or allergic reactions to the administration of immunobiological drugs, known allergic reactions to any of the components of the vaccine or vaccine containing similar components, exacerbation of allergic diseases on the day of inclusion in the Study;
The presence of neoplasms (ICD codes C00-D09) (according to anamnesis);
Splenectomy (according to the anamnesis);
Neutropenia (decrease in the absolute number of neutrophils less than 1000 cells / mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin concentration less than 80 g/l) - 6 month prior to inclusion in the Study (according to the anamnesis);
Volunteers with an active form of the disease caused by the human immunodeficiency virus, syphilis, hepatitis B and C (according to the anamnesis);
Anorexia, protein deficiency of any origin;
Alcoholism and drug addiction (according to the anamnesis);
Participation in any other clinical trial 90 days prior to the screening;
Extensive tattoos at the injection sites (deltoid muscle area), which do not allow to assess the local reaction to the introduction of investigational medicinal product (IMP);
Any other condition of the volunteer of the Study, which, in the opinion of the research physician, may prevent the completion of the study in accordance with the protocol;
Vaccination against COVID-19 or transmitted coronavirus infection (COVID-19) less than 6 months prior to the screening;
Multiple administration of the Sputnik V vaccine, Sputnik Lite, or multiple administration of any other COVID-19 vaccine for more than three injections (Sputnik V vaccination plus Sputnik Lite revaccination);
Inability to read in Russian; inability or unwillingness to understand the essence of the Study;
Any other conditions that limit the validity of obtaining informed consent or may affect the ability of a volunteer to participate in the Study.
Staff of research centers (chief researcher and members of the research team) directly involved in the research and their family members.

About this study

Official title: Safety, Reactogenicity and Immunogenicity Study of the Vector Vaccine GamCovidVac for the Prevention of Coronavirus (COVID-19) Infection Caused by the SARS-CoV-2 Virus With Altered Antigenic Profile With Participation of Adult Volunteers

Conditions: COVID-19
Being tested: GamCovidVac vector vaccine for the prevention of COVID-19 (with altered antigenic profile)
Medical subject headings: COVID-19

What participants receive

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

GamCovidVac vector vaccine for the prevention of COVID-19 (with altered antigenic profile)Biological
Two intramuscular injections of the GamCovidVac vector vaccine for the prevention of COVID-19 (with altered antigenic profile) will be performed. 1st injection - component I, 2nd injection - component II.

Study groups in NCT06068569
Study group	Role	What they receive
Healthy patients	Experimental	Drug: GamCovidVac vector vaccine for the prevention of COVID-19 (with altered antigenic profile); A total of 50 people will be randomized and receive the study drug (vaccine). Two intramuscular injections of the investigational medicinal product (IMP) will be performed. 1st injection - component I, 2nd injection - component II. Receives: Biological: GamCovidVac vector vaccine for the prevention of COVID-19 (with altered antigenic profile)

What is being measured

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

Occurrence of adverse events (AE)
Occurrence of adverse events (AE)
Measured: Within 28 days after administration of the drug
Occurrence of serious adverse events (SAEs)
Occurrence of serious adverse events (SAEs)
Measured: Throughout Study completion, until December 2024

Timeline

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

Oct 2023Dec 2024

First posted5 Oct 2023
Study startOct 2023 (estimated)
Primary completionDec 2024 (estimated)
Study completionDec 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies 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 3
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06068569
Sponsor's protocol ID: 12-GamCovidVac/N-2023
Status last verified: Sep 2023
First submitted: 26 Sep 2023
Last updated: 5 Oct 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Shuliakova IV, Grousova DM, Iliukhina AA, Dzharullaeva AS, Lubenets NL, Ordzhonikidze MK, Izhaeva FM, Erokhova AS, Zorkov ID, Azizyan VV, Boeva ZD, Reshetnikov DA, Ermolova IA, Lega VA, Kovyrshina AV, Bukhtin KM, Romanova LP, Alekseeva EI, Borzakova SN, Rachina SA, Rusanova MG, Ozharovskaia TA, Popova O, Zrelkin DI, Zubkova OV, Tukhvatulin AI, Tukhvatulina NM, Shcheblyakov DV, Favorskaya IA, Esmagambetov IB, Karpov AP, Semikhin AS, Pochtovyi AA, Naroditskiy BS, Gushchin VA, Gintsburg AL, Logunov DY. Sputnik V update: safety and neutralizing antibodies in healthy adults and adolescents. Front Immunol. 2026 Mar 26;17:1736771. doi: 10.3389/fimmu.2026.1736771. eCollection 2026.
PubMed 41972135

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?

Official record

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19

All COVID-19 trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety, Reactogenicity and Immunogenicity Study of the Vector Vaccine GamCovidVac for the Prevention of Coronavirus (COVID-19) Infection Caused by the SARS-CoV-2 Virus With Altered Antigenic Profile With Participation of Adult Volunteers
ClinicalTrials.gov ID: NCT06068569
Acronym / sponsor ID: 12-GamCovidVac/N-2023
Conditions: COVID-19
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 50 participants (estimated)
Lead sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian FederationUniversity, hospital or other
Study start: Oct 2023 (estimated)
Primary completion: Dec 2024 (estimated)
Study completion: Dec 2024 (estimated)
First posted: 5 Oct 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.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Healthy patients	Experimental	Biological: GamCovidVac vector vaccine for the prevention of COVID-19 (with altered antigenic profile)Drug: GamCovidVac vector vaccine for the prevention of COVID-19 (with altered antigenic profile); A total of 50 people will be randomized and receive the study drug (vaccine). Two intramuscular injections of the investigational medicinal product (IMP) will be performed. 1st injection - component I, 2nd injection - component II.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Written informed consents to participate in the Study;
Adult volunteers men and women over 18 years old;
A negative test result for COVID-19, determined by PCR or express method before the introduction of the investigational medicinal product (IMP);
Consent to the use of effective methods of contraception during the entire period of participation in the Study;
A negative pregnancy test based on the results of a urine test at a screening visit (for women with preserved reproductive potential);

Key exclusion criteria (22 listed)

Volunteers cannot be included in the Study if there is at least one of the following criteria for non-inclusion:
No written informed consents to participate in the Study
Therapy with steroids (with the exception of hormonal contraceptives and/or hormone replacement therapy) and / or immunoglobulins or other blood products that did not end 30 days before inclusion in the Study;
Therapy with any immunosuppressive drugs completed less than 3 months prior to inclusion in the Study;
Female volunteers during pregnancy or lactation;

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
GamCovidVac vector vaccine for the prevention of COVID-19 (with altered antigenic profile)Two intramuscular injections of the GamCovidVac vector vaccine for the prevention of COVID-19 (with altered antigenic profile) will be performed. 1st injection - component I, 2nd injection - component II.	Biological	Healthy patients

Primary outcome

Occurrence of adverse events (AE)
Time frame: Within 28 days after administration of the drug
Occurrence of adverse events (AE)
Occurrence of serious adverse events (SAEs)
Time frame: Throughout Study completion, until December 2024
Occurrence of serious adverse events (SAEs)

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
Derived from this study: PubMed 41972135Shuliakova IV, Grousova DM, Iliukhina AA, Dzharullaeva AS, Lubenets NL, Ordzhonikidze MK, Izhaeva FM, Erokhova AS, Zorkov ID, Azizyan VV, Boeva ZD, Reshetnikov DA, Ermolova IA, Lega VA, Kovyrshina AV, Bukhtin KM, Romanova LP, Alekseeva EI, Borzakova SN, Rachina SA, Rusanova MG, Ozharovskaia TA, Popova O, Zrelkin DI, Zubkova OV, Tukhvatulin AI, Tukhvatulina NM, Shcheblyakov DV, Favorskaya IA, Esmagambetov IB, Karpov AP, Semikhin AS, Pochtovyi AA, Naroditskiy BS, Gushchin VA, Gintsburg AL, Logunov DY. Sputnik V update: safety and neutralizing antibodies in healthy adults and adolescents. Front Immunol. 2026 Mar 26;17:1736771. doi: 10.3389/fimmu.2026.1736771. eCollection 2026.
Individual participant dataSharing planned: Undecided

Related trials for COVID-19

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19

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.

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 11 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Results are not available in the source record.

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?

Occurrence of adverse events (AE) (time frame: Within 28 days after administration of the drug). The study lists 2 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 NCT06068569, which also lists 1 linked publication.

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 5 Oct 2023.