Coronavirus InfectionPhase 2NCT04587219
The Study of "Gam-COVID-Vac" Vaccine Against COVID-19 With the Participation of Volunteers of 60 y.o and Older
A Phase 2 study testing Gam-COVID-Vac in people with Coronavirus Infection, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation at 1 site in Russia.
Trial summary
The purpose of this study: to assess the safety, tolerability and immunogenicity of the drug "Gam-COVID-Vac", a solution for intramuscular injection, at various times after vaccination in volunteers over 60 years of age Read more about this study
- Who is it for?
- Ages 60 to 111 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Infection
- What is being tested?
- Gam-COVID-Vac
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteRussia
- Study dates
- 22 Oct 2020to 30 Apr 2021
- 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 111 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The written informed consent of the subject for participation in the study;
- Men and women over the age of 60 years inclusive;
- Negative result of research on HIV, hepatitis, syphilis;
- negative test result for the presence of IgM and IgG antibodies to SARS CoV2 by enzyme immunoassay;
- negative test result for COVID-2019, determined by PCR at the screening session;
- The absence of a history COVID-2019;
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- No contact of the study subject with COVID-2019 patients for at least 14 days prior to inclusion in the study (according to the study participant);
- Consent to use effective methods of contraception during the entire period of participation in the study;
- A negative test for the presence of narcotic and psychoactive agents in urine at the screening visit;
- A negative test for alcohol at screening visit;
- negative pregnancy test (performed for women with preserved reproductive potential)
- No history of severe postvaccinal reactions or postvaccinal complications after the use of immunobiological drugs;
- absence of acute infectious and/or respiratory diseases for at least 14 days prior to inclusion in the study.
Who cannot join
- any vaccination/immunization performed within 30 days prior to inclusion in The study;
- therapy with steroids (with the exception of hormonal contraceptives and drugs used as hormone replacement therapy for menopause) and/or immunoglobulins or other blood products that did not end 30 days before inclusion in the study;
- Therapy immunosuppressive drugs, which ended less than 3 months before inclusion in the study;
- Subjects of the female gender during pregnancy or breastfeeding;
- Postponed less than one year before inclusion in the study, acute coronary syndrome or stroke;
- Tuberculosis, chronic systemic infections;
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- burdened allergic history (the presence in the history of information about anaphylactic shock, Quincke's edema, polymorphic exudative eczema, atopy, serum sickness), hypersensitivity or allergic reactions to the introduction of immunobiological drugs, known allergic reactions to the components of the drug, exacerbation of allergic diseases on the day of inclusion in the study;
- the presence of a history of neoplasms (ICD codes C00-D09);
- donation of blood or plasma (450 ml or more) less than 2 months before inclusion in the study;
- Splenectomy in history;
- Neutropenia (decrease in the absolute number of neutrophils less than 1000/mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin less than 80 g/l), a history of immunodeficiency for 6 months before inclusion in the study;
- Subjects with an active form of the disease caused by the human immunodeficiency virus, syphilis, hepatitis B and C;
- Anorexia, protein deficiency of any origin;
- extensive tattoos at the sites of drug administration (deltoid muscle area), which do not allow to assess the local response to the introduction of ILP;
- Alcoholism and drug addiction in history;
- Consists on the account at the psychiatrist;
- subject's participation in any other interventional clinical trial within 90 days prior to the start of this study;
- any other condition of the research subject that, in the opinion of the research doctor, may prevent the completion of the study in accordance with The Protocol;
- staff of research centers and other employees directly involved in the research (members of the research team) and their families.
- severe comorbid diseases that, in the opinion of the research doctor, may prevent participation in the study.
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Trial locations and contacts
1 site in 1 country.
Russia1 site
Federal state budgetary institution "Central clinical hospital with polyclinic" Of the office Of the President of the Russian Federation
Moscow
About this study
Official title: An Open Study of the Safety, Tolerability and Immunogenicity of the "Gam-COVID-Vac"Vaccine Against COVID-19 (Solution for Intramuscular Injection) With the Participation of Volunteers in the Age Group Over 60 Years
The purpose of this study: to assess the safety, tolerability and immunogenicity of the drug "Gam-COVID-Vac", a solution for intramuscular injection, at various times after vaccination in volunteers over 60 years of age
Read the detailed description
An open-ended prospective non-randomized study involving volunteers over the age of 60.
The study will include 110 volunteers. who will receive the test drug according to the prime-boost scheme: the introduction of component 1 will be carried out on the 1st day, and component 2 - on the 21st day of the study. Outpatient monitoring will be performed during 4 visits: on the 7th, 14th, 28th, and 42nd days after the vaccine administration Also two visits will be performed in the phone contact mode for 90 and 180 days
- Conditions
- Coronavirus Infection
- Being tested
- Gam-COVID-Vac
- Keywords
- COVID-19, vaccine, vector vaccine, Immunologic Factors, 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.
Gam-COVID-VacBiological
combined vector vaccine, 0,5ml/dose+0,5 ml/dose prime-boost immunization in days 1 (component I rAd26-S) and 21(component II rAd5-S)
| Study group | Role | What they receive |
|---|---|---|
| Gam COVID Vac Vaccine | Experimental | the test drug will be administered according to the prime-boost scheme: the introduction of component 1 (Ad26) will be carried out on the 1st day, and component 2(Ad5)- on the 21st day of the study. Receives: Biological: Gam-COVID-Vac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changing of antibody levels against the SARS-CoV-2 glycoprotein S in 42 days
Determination of antibody levels against the SARS-CoV-2 glycoprotein S measured by an ELISA vs. baseline values
Measured: at days 0, 21, 28, 42
Number of Participants With Adverse Events
Determination of Number of Participants With Adverse Events
Measured: through the whole study, an average of 180 days
Secondary outcomes (2)
Changing of of virus neutralizing antibody titer
Determination of virus neutralizing antibody titer
Measured: at days 0, 28, 42
Changing of antigen-specific cellular immunity level
Determination of antigen-specific cellular immunity
Measured: Time Frame: at days 0,28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start22 Oct 2020
- Primary completion30 Mar 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus 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
- Not applicable
- Intervention model
- Single group
- Model description
- Open prospective non-randomized study
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
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
- Investigators
- Nikita Lomakin, MD, PhD, Principal investigator, Federal state budgetary institution "Central clinical hospital with polyclinic" Of the office Of the President of the Russian Federation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587219
- Sponsor's protocol ID
- 05-Gam-COVID-Vac-2020
- Status last verified
- Oct 2020
- First submitted
- 13 Oct 2020
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Study of the Safety, Tolerability and Immunogenicity of the "Gam-COVID-Vac"Vaccine Against COVID-19 (Solution for Intramuscular Injection) With the Participation of Volunteers in the Age Group Over 60 Years
- ClinicalTrials.gov ID
- NCT04587219
- Acronym / sponsor ID
- 05-Gam-COVID-Vac-2020
- Conditions
- Coronavirus Infection
- Keywords
- COVID-19, vaccine, vector vaccine, Immunologic Factors, SARS-CoV-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian FederationUniversity, hospital or other
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 30 Mar 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 14 Oct 2020 (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.
The purpose of this study: to assess the safety, tolerability and immunogenicity of the drug "Gam-COVID-Vac", a solution for intramuscular injection, at various times after vaccination in volunteers over 60 years of age
Detailed description
An open-ended prospective non-randomized study involving volunteers over the age of 60.
The study will include 110 volunteers. who will receive the test drug according to the prime-boost scheme: the introduction of component 1 will be carried out on the 1st day, and component 2 - on the 21st day of the study. Outpatient monitoring will be performed during 4 visits: on the 7th, 14th, 28th, and 42nd days after the vaccine administration Also two visits will be performed in the phone contact mode for 90 and 180 days
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open prospective non-randomized study
| Arm | Type | Receives |
|---|---|---|
| Gam COVID Vac Vaccine | Experimental | Biological: Gam-COVID-Vacthe test drug will be administered according to the prime-boost scheme: the introduction of component 1 (Ad26) will be carried out on the 1st day, and component 2(Ad5)- on the 21st day of the study. |
Who may qualify
- Ages
- 60 to 111 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- The written informed consent of the subject for participation in the study;
- Men and women over the age of 60 years inclusive;
- Negative result of research on HIV, hepatitis, syphilis;
- negative test result for the presence of IgM and IgG antibodies to SARS CoV2 by enzyme immunoassay;
- negative test result for COVID-2019, determined by PCR at the screening session;
Key exclusion criteria (21 listed)
- any vaccination/immunization performed within 30 days prior to inclusion in The study;
- therapy with steroids (with the exception of hormonal contraceptives and drugs used as hormone replacement therapy for menopause) and/or immunoglobulins or other blood products that did not end 30 days before inclusion in the study;
- Therapy immunosuppressive drugs, which ended less than 3 months before inclusion in the study;
- Subjects of the female gender during pregnancy or breastfeeding;
- Postponed less than one year before inclusion in the study, acute coronary syndrome or stroke;
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 |
|---|---|---|
| Gam-COVID-Vaccombined vector vaccine, 0,5ml/dose+0,5 ml/dose prime-boost immunization in days 1 (component I rAd26-S) and 21(component II rAd5-S) | Biological | Gam COVID Vac Vaccine |
Primary outcome
Changing of antibody levels against the SARS-CoV-2 glycoprotein S in 42 days
Time frame: at days 0, 21, 28, 42
Determination of antibody levels against the SARS-CoV-2 glycoprotein S measured by an ELISA vs. baseline values
Number of Participants With Adverse Events
Time frame: through the whole study, an average of 180 days
Determination of Number of Participants With Adverse Events
2 secondary outcomes
Changing of of virus neutralizing antibody titer
Time frame: at days 0, 28, 42
Changing of antigen-specific cellular immunity level
Time frame: Time Frame: at days 0,28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Individual participant dataSharing planned: No
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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.
Nikita Lomakin, MD, PhD principal investigator
Federal state budgetary institution "Central clinical hospital with polyclinic" Of the office Of the President of the Russian Federation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gam-COVID-Vac in people with Coronavirus Infection, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation at 1 site in Russia.
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 13 inclusion and 21 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 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Changing of antibody levels against the SARS-CoV-2 glycoprotein S in 42 days (time frame: at days 0, 21, 28, 42). 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?
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 22 Jan 2021.