COVID-19Phase 3NCT06068556
Study of the Vector Vaccine GamCovidVac-M (Altered Antigenic Composition)
A Phase 3 study testing GamCovidVac-M vector vaccine for the prevention of COVID-19 with altered antigenic composition in people with COVID-19, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation.
Trial summary
Safety, reactogenicity and immunogenicity study of the vector vaccine GamCovidVac-M for the prevention of coronavirus (COVID-19) infection caused by the SARS-CoV-2 virus with altered antigenic composition with participation of 12-17 years old volunteers. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- GamCovidVac-M vector vaccine for the prevention of COVID-19 with altered antigenic composition
- 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 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
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, obtained from: the volunteer, his/her parent or a legal guardian;
- 12-17 years old teenagers (men and women);
- A negative test result for COVID-19, determined by PCR or express method before the introduction of the investigational medicinal product (IMP);
- No COVID-19 during 6 months prior to the screening (according to the anamnesis);
- No contact of the volunteer with COVID-19 patients for at least 14 days prior to inclusion in the Study (according to the volunteer, his/her parent or a legal guardian);
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- 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);
- Negative test for the presence of narcotic and psychostimulants in the urine at the screening visit;
- 8. Negative alcohol content test at the screening visit; 9. No history of pronounced post-vaccination reactions or post-vaccination complications after the use of immunobiological drugs (according to the anamnesis); 9. 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:
- Any vaccination/immunization carried out within 30 days prior to inclusion 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;
- Acute coronary syndrome or stroke suffered less than one year prior to inclusion in the Study;
- Any immunodeficiency (for example, hereditary immunodeficiency, acquired immunodeficiency syndrome [AIDS], etc.);
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- Infectious diseases (according to the anamnesis): history of HIV, hepatitis, active form of syphilis at the time of screening; Tuberculosis; Active infection (with the exception of onychomycosis), or any acute infection episode requiring treatment with antibiotics intravenously for 4 weeks prior to screening or orally for 2 weeks prior to screening; History (according to the anamnesis) of serious recurrent or chronic infection, not listed above;
- Extensive surgery within 4 weeks prior to screening;
- Chronic autoimmune diseases or systemic collagenoses (according to the anamnesis), requiring the prescription of immunosuppressive therapy;
- Volunteers who have undergone organ transplantation, including bone-marrow transplantation or peripheral blood stem cell transplantation and receive immunosuppressive therapy;
- Splenectomy (according to the anamnesis);
- Volunteers with a previous or concomitant history of neoplasms (ICD codes C00-D09);
- 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;
- 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), thrombocytopenia (decrease in the absolute number of platelets less than 50,000 cells/ mm3);
- Anorexia, protein deficiency of any origin;
- Volunteers with a BMI value in the range from -2 SD to +2 SD, according to their age;
- 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);
- Chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal tract, liver, kidneys, muscle and connective tissue in the stage of exacerbation or decompensation;
- Presence of mental abnormalities (registered as psychiatrist's/narcologist's patient);
- Diseases, the presence of which, from the point of view of the research doctor, puts the participant's health at risk in case of participation in the Study or potentially complicates the interpretation of the results of the examination;
- Family members of the staff of research centers directly involved in the research;
- The subject's participation in any other clinical trial 90 days prior to the screening;
- Planned vaccination against COVID-19 with any vaccine, both in the framework of other studies and civil circulation;
- Vaccination against COVID-19 or transmitted coronavirus infection COVID-19 less than 6 months prior to the screening;
- Female volunteers during pregnancy or lactation;
- 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.
About this study
Official title: Safety, Reactogenicity and Immunogenicity Study of the Vector Vaccine GamCovidVac-M for the Prevention of Coronavirus (COVID-19) Infection Caused by the SARS-CoV-2 Virus With Altered Antigenic Composition With Participation of 12-17 Years Old Volunteers.
Safety, reactogenicity and immunogenicity study of the vector vaccine GamCovidVac-M for the prevention of coronavirus (COVID-19) infection caused by the SARS-CoV-2 virus with altered antigenic composition with participation of 12-17 years old volunteers.
- Conditions
- COVID-19
- Being tested
- GamCovidVac-M vector vaccine for the prevention of COVID-19 with altered antigenic composition
- 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-M vector vaccine for the prevention of COVID-19 with altered antigenic compositionBiological
Two intramuscular injections of GamCovidVac-M vector vaccine for the prevention of COVID-19 with altered antigenic composition will be performed. 1st injection - component I, 2nd injection - component II.
| Study group | Role | What they receive |
|---|---|---|
| Healthy patients | Experimental | Drug: GamCovidVac-M vector vaccine for the prevention of COVID-19 with altered antigenic composition. A total of 50 people will be randomized and receive the study drug. Two intramuscular injections of GamCovidVac-M vector vaccine for the prevention of COVID-19 with altered antigenic composition will be performed. 1st injection - component I, 2nd injection - component II. Receives: Biological: GamCovidVac-M vector vaccine for the prevention of COVID-19 with altered antigenic composition |
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 7 days after each administration of the drug
Occurrence of serious adverse events (SAEs)
Occurrence of serious adverse events (SAEs)
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- 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)
Sponsor and investigators
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068556
- Sponsor's protocol ID
- 13-GamCovidVac-M/N-2023
- Status last verified
- Sep 2023
- First submitted
- 22 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
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-M for the Prevention of Coronavirus (COVID-19) Infection Caused by the SARS-CoV-2 Virus With Altered Antigenic Composition With Participation of 12-17 Years Old Volunteers.
- ClinicalTrials.gov ID
- NCT06068556
- Acronym / sponsor ID
- 13-GamCovidVac-M/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.
Safety, reactogenicity and immunogenicity study of the vector vaccine GamCovidVac-M for the prevention of coronavirus (COVID-19) infection caused by the SARS-CoV-2 virus with altered antigenic composition with participation of 12-17 years old volunteers.
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-M vector vaccine for the prevention of COVID-19 with altered antigenic compositionDrug: GamCovidVac-M vector vaccine for the prevention of COVID-19 with altered antigenic composition. A total of 50 people will be randomized and receive the study drug. Two intramuscular injections of GamCovidVac-M vector vaccine for the prevention of COVID-19 with altered antigenic composition will be performed. 1st injection - component I, 2nd injection - component II. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Written informed consents to participate in the study, obtained from: the volunteer, his/her parent or a legal guardian;
- 12-17 years old teenagers (men and women);
- A negative test result for COVID-19, determined by PCR or express method before the introduction of the investigational medicinal product (IMP);
- No COVID-19 during 6 months prior to the screening (according to the anamnesis);
- No contact of the volunteer with COVID-19 patients for at least 14 days prior to inclusion in the Study (according to the volunteer, his/her parent or a legal guardian);
Key exclusion criteria (26 listed)
- Volunteers cannot be included in the study if there is at least one of the following criteria for non-inclusion:
- Any vaccination/immunization carried out within 30 days prior to inclusion 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;
- Acute coronary syndrome or stroke suffered less than one year prior to inclusion in the Study;
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-M vector vaccine for the prevention of COVID-19 with altered antigenic compositionTwo intramuscular injections of GamCovidVac-M vector vaccine for the prevention of COVID-19 with altered antigenic composition will be performed. 1st injection - component I, 2nd injection - component II. | Biological | Healthy patients |
Primary outcome
Occurrence of adverse events (AE)
Time frame: Within 7 days after each administration of the drug
Occurrence of adverse events (AE)
Occurrence of serious adverse events (SAEs)
Time frame: Through study completion, an average of 1 year
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
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GamCovidVac-M vector vaccine for the prevention of COVID-19 with altered antigenic composition in people with COVID-19, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation.
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 10 inclusion and 26 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 7 days after each 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 NCT06068556, 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; AzTrials last refreshed its copy on 6 Nov 2026.