Covid19Phase 2/3OLSTADNCT04954092
Study of Gam-COVID-Vac in Adolescents
A Phase 2/3 study testing Gam-COVID-vac M in people with Covid19 and Vaccine Preventable Disease, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation at 2 sites in Russia.
Trial summary
Double-blind, placebo-controlled study with open dose selection period for safety assessment, tolerance and immunogenicity of the drug "GamKOVID-Vac M, a combined vector vaccine for prevention of coronavirus infection caused by the virus SARS-CoV-2" in adolescents Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19, Vaccine Preventable Disease
- What is being tested?
- Gam-COVID-vac M
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,000 participants
- Where
- 2 sitesRussia
- Study dates
- 5 Jul 2021to 31 Dec 2023
- Phase
- Phase 2/3
- 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
- Availability of written informed consent of the research subject and parents / adoptive parents of the subject to participate in the research;
- Boys and girls aged 12-17 inclusive;
- Negative test result for HIV, hepatitis, syphilis;
- A negative test result for the presence of IgM and IgG antibodies to SARS CoV2 by enzyme immunoassay, as well as, if available, the result of an examination performed in medical institutions of the Moscow City Health Department 7 days prior to inclusion in the study can be taken into account;
- A negative test result for COVID-2019, determined by the PCR method at the screening visit, and, if available, can be taken into account the result of the examination performed in the medical organizations of the Moscow City Health Department 7 days before being included in the study;
- No history of COVID-2019;
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- Absence of contact of the research subject with COVID-2019 patients for at least 14 days prior to inclusion in the research (according to the research participant, parents / adoptive parents of the subject);
- Consent to the use of effective contraceptive methods during the entire period of participation in the study;
- Negative pregnancy test based on urine test results at the screening visit (for all girls - study participants);
- Negative test for the presence of drugs and psychostimulants in the urine at the screening visit;
- Negative alcohol test at screening visit;
- No history of pronounced post-vaccination reactions or post-vaccination complications after the use of immunobiological drugs;
- Absence of acute infectious and / or respiratory diseases for at least 14 days prior to enrollment in the study
Who cannot join
- Any vaccination / immunization carried out within 30 days prior to enrollment in the study.
- Therapy with steroids (with the exception of hormonal contraceptive drugs) and / or immunoglobulins or other blood products, not completed 30 days before enrollment in the study;
- Immunosuppressive therapy and systemic therapy with corticosteroid drugs, completed in less than 3 months. prior to inclusion in the study.
- Postponed acute coronary syndrome or stroke less than one year before inclusion in the study
- Any immunodeficiency (for example, hereditary immunodeficiency, acquired immunodeficiency syndrome [AIDS], etc.).
- Infectious diseases:
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- history of HIV (antibodies to HIV type 1 or 2), positive test for HBsAg or HCV RNA [qualitative]), active form of syphilis;
- Tuberculosis;
- Active infection (with the exception of onychomycosis), or any significant episode of infection requiring intravenous antibiotic treatment for 4 weeks before screening or by mouth for 2 weeks before screening;
- A history of a serious recurrent or chronic infection not listed above.
- Major surgery within 4 weeks prior to screening.
- Chronic autoimmune diseases or systemic collagenoses in history, requiring the appointment of immunosuppressive therapy.
- Volunteers who have undergone organ transplants, including bone marrow or peripheral blood stem cell (PBC) transplants, and are receiving immunosuppressive therapy.
- History of splenectomy.
- Volunteers with a previous or concomitant history of neoplasms (ICD codes C00-D09).
- A burdened allergic history (history of anaphylactic shock, Quincke's edema and other life-threatening conditions), hypersensitivity or allergic reactions to the administration of immunobiological preparations, known allergic reactions to any component of a 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 <18 (low body weight) or a BMI ≥ 35 kg / m2.
- Extensive tattoos at the injection sites (deltoid muscle area), which do not allow assessing the local response to the injection of ILP.
- 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 or suspicion of drug, alcohol or drug addiction and other mental disorders.
- Diseases, the presence of which, from the point of view of the medical researcher, puts the health of the participant at risk if participating in the study or potentially complicates the interpretation of the results of the examination.
- Family members of staff of research centers directly involved in the conduct of research, etc.
- Participation in other clinical trials and use of other investigational drugs within 28 days of screening.
- Planned vaccination against COVID-19 with any vaccine, both in the framework of other studies and in the framework of civil appeal.
- Female subjects during pregnancy or lactation
- Inability to read in Russian; inability or unwillingness to understand the essence of the research. Any other conditions that limit the eligibility of obtaining informed consent or that may affect the volunteer's ability to participate in the study affect the volunteer's ability to take part in the study
Trial locations and contacts
2 sites in 1 country.
Russia2 sites, 2 recruiting
- Recruiting
Children's City Clinical Hospital named after Z.A. Bashlyaeva of the Moscow Department of Health
Moscow
Svetlana Borzakova
- Recruiting
Morozovskaya Children's City Clinical Hospital of the Moscow Department of Health
Moscow
Anna Vlasova
About this study
Official title: An Open Label Study With an Open Dose Selection Period to Assess the Safety, Tolerability and Immunogenicity of the Drug "Gam-COVID-Vac, a Combined Vector Vaccine for the Prevention of Coronavirus Infection Caused by the SARS-CoV-2 Virus", With the Participation of Adolescent Volunteers
Double-blind, placebo-controlled study with open dose selection period for safety assessment, tolerance and immunogenicity of the drug "GamKOVID-Vac M, a combined vector vaccine for prevention of coronavirus infection caused by the virus SARS-CoV-2" in adolescents
Read the detailed description
The study will include healthy volunteers aged 12-17 years inclusive. Volunteers will be recruited in at least two clinical centers. Teams will be divided into subgroups to ensure the safety of volunteers during hospitalization amid the ongoing pandemic.
Stage 1 (Phase I-II) - 100 volunteers will be included in two dosing groups (50 in each group), a sufficient number of volunteers should be screened (no more than 7 days before inclusion in the study). To ensure the required number of volunteers who have completed screening procedures (pre-screening procedures can be organized).
The conditions of the study were the selection of doses (administration of the drug and observation for 48 hours) in a hospital setting, the rest of the visits were outpatient.
It is planned to start the study with a dose of 1/10 of the full adult dose. Volunteers will be hospitalized the day before vaccination. It is allowed to carry out screening procedures the day before vaccination in a hospital setting, subject to the prior approval of the volunteer based on the results of pre-screening. The first dose will be administered on day 1. After that, the volunteer will be monitored in the hospital for 48 hours. on days 3 and 7, a telephone consultation will be held. With a favorable safety profile after 7 days after the 1/10 dose, the Principal Investigators present a consolidated decision to escalate the dose to 1/5 of the adult dose on ICMD.
The transition to the next stage is planned on the basis of the report on the safety and tolerability of ILS on the 28th day after the introduction of the first component. The selected dose will be determined based on the immunogenicity scores at day 28, which should be consistent with the immunogenicity in adults after receiving the full dose of ILP.
Stage 2 (Phase III) - 3000 volunteers to be randomized to two groups - active drug and placebo in a ratio of 4: 1. Volunteers will receive the drug at the dose selected in the first phase. Research is carried out on an outpatient basis.
The randomization of research subjects will be carried out in two age strata: 12-14 years old and 15-17 years old.
The intramuscular vaccine will be administered at vaccination visits # 2 and # 3 (Day 1 and Day 21 ± 2) on an outpatient basis. After vaccination, TMK will be carried out for 2 days.
Follow-up visits # 4 (28 ± 2), 5 (42 ± 4), 6 (90 ± 7) and 7 (180 ± 14); TMK for 270 ± 14 and 365 ± 14 days.
Additionally historical control data will be used (data from phase III clinical trials of efficacy, safety and immunogenicity obtained during their evaluation in a sample of adult volunteers aged 18-21 years);
The duration of study participation for one subject will be 365 ± 14 days after the first dose of vaccine, during which each subject will undergo a screening visit, two hospitalizations for drug administration, five face-to-face visits to the investigator, and telephone contacts with the investigator.
The data of research subjects will be collected using electronic forms of individual registration cards, as well as using electronic questionnaires (diaries) filled in by research subjects.
- Conditions
- Covid19, Vaccine Preventable Disease
- Being tested
- Gam-COVID-vac M, Placebo
- Keywords
- rAd vector based vaccine, Sputnik, rAd26, rAd5, adolescent
- Medical subject headings
- COVID-19, Vaccine-Preventable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gam-COVID-vac MBiological
The vaccine consists of two components: component I and component II. Component I includes a recombinant adenoviral vector based on human adenovirus serotype 26 carrying the gene for the S-protein of the SARS-CoV-2 virus, component II includes a vector based on human adenovirus serotype 5 carrying the protein S gene of the SARS-CoV-2 virus
PlaceboBiological
Composition without active ingredients
| Study group | Role | What they receive |
|---|---|---|
| 1/10 of full adult dose | Experimental | Not described Receives: Biological: Gam-COVID-vac M |
| 1/5 of full adult dose | Experimental | Not described Receives: Biological: Gam-COVID-vac M |
| Selected dose for second stage of the trial | Experimental | Not described Receives: Biological: Gam-COVID-vac M |
| Placebo for second stage of the trial | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean titer of antigen-specific IgGs
To define geometric mean titer of antigen-specific IgGs after vaccination
Measured: 21, 28, 42, 90, 180 days
Geometric mean titer of neutralizing antibodies
To define geometric mean titer of neutralizing antibodies against SARS-Cov-2 virus after vaccination
Measured: 21, 28, 42, 90, 180 days
IFN-gamma secretion by T lymphocytes
To define changes in level of IFN-gamma secretion by T lymphocytes under antigen stimulation
Measured: 21, 28, 42, 90, 180 days
Frequency of adverse reactions
Frequency of vaccine-related adverse reactions
Measured: 365+/-14 days
Severity of adverse reactions
Severity of vaccine-related adverse reactions
Measured: 365+/-14 days
Secondary outcomes (1)
Incidence of COVID-19 cases
Incidence of mild, moderate, severe, extremely severe cases and deaths due to COVID-19
Measured: within 28 to 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start5 Jul 2021
- Primary completion6 Nov 2022 (estimated)
- Study completion31 Dec 2023 (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 Covid19Studies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,000 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
- Collaborators
- Moscow Healthcare Department
- Responsible party
- Sponsor
- Investigators
- Anna Vlasova, Principal investigator, Morozovskaya Children's City Clinical Hospital of the Moscow Department of HealthSvetlana Borzakova, Principal investigator, Children's City Clinical Hospital named after Z.A. Bashlyaeva of the Moscow Department of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954092
- Sponsor's protocol ID
- OLSTAD
- Acronym
- OLSTAD
- Status last verified
- Sep 2021
- First submitted
- 5 Jul 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tukhvatulin AI, Dolzhikova IV, Dzharullaeva AS, Grousova DM, Kovyrshina AV, Zubkova OV, Zorkov ID, Iliukhina AA, Shelkov AY, Erokhova AS, Popova O, Ozharovskaia TA, Zrelkin DI, Izhaeva FM, Shcheblyakov DV, Esmagambetov IB, Tokarskaya EA, Nikitenko NA, Lubenets NL, Khadorich EA, Gushchin VA, Borzakova SN, Vlasova AV, Osmanov IM, Gorev VV, Naroditsky BS, Logunov DY, Gintsburg AL. Safety and immunogenicity of rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine against SARS-CoV-2 in healthy adolescents: an open-label, non-randomized, multicenter, phase 1/2, dose-escalation study. Front Immunol. 2023 Aug 1;14:1228461. doi: 10.3389/fimmu.2023.1228461. eCollection 2023.
PubMed 37600800
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study With an Open Dose Selection Period to Assess the Safety, Tolerability and Immunogenicity of the Drug "Gam-COVID-Vac, a Combined Vector Vaccine for the Prevention of Coronavirus Infection Caused by the SARS-CoV-2 Virus", With the Participation of Adolescent Volunteers
- ClinicalTrials.gov ID
- NCT04954092
- Acronym / sponsor ID
- OLSTAD / OLSTAD
- Conditions
- Covid19, Vaccine Preventable Disease
- Keywords
- rAd vector based vaccine, Sputnik, rAd26, rAd5, adolescent
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian FederationUniversity, hospital or other
- Collaborators
- Moscow Healthcare Department
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 6 Nov 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 8 Jul 2021 (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.
Double-blind, placebo-controlled study with open dose selection period for safety assessment, tolerance and immunogenicity of the drug "GamKOVID-Vac M, a combined vector vaccine for prevention of coronavirus infection caused by the virus SARS-CoV-2" in adolescents
Detailed description
The study will include healthy volunteers aged 12-17 years inclusive. Volunteers will be recruited in at least two clinical centers. Teams will be divided into subgroups to ensure the safety of volunteers during hospitalization amid the ongoing pandemic.
Stage 1 (Phase I-II) - 100 volunteers will be included in two dosing groups (50 in each group), a sufficient number of volunteers should be screened (no more than 7 days before inclusion in the study). To ensure the required number of volunteers who have completed screening procedures (pre-screening procedures can be organized).
The conditions of the study were the selection of doses (administration of the drug and observation for 48 hours) in a hospital setting, the rest of the visits were outpatient.
It is planned to start the study with a dose of 1/10 of the full adult dose. Volunteers will be hospitalized the day before vaccination. It is allowed to carry out screening procedures the day before vaccination in a hospital setting, subject to the prior approval of the volunteer based on the results of pre-screening. The first dose will be administered on day 1. After that, the volunteer will be monitored in the hospital for 48 hours. on days 3 and 7, a telephone consultation will be held. With a favorable safety profile after 7 days after the 1/10 dose, the Principal Investigators present a consolidated decision to escalate the dose to 1/5 of the adult dose on ICMD.
The transition to the next stage is planned on the basis of the report on the safety and tolerability of ILS on the 28th day after the introduction of the first component. The selected dose will be determined based on the immunogenicity scores at day 28, which should be consistent with the immunogenicity in adults after receiving the full dose of ILP.
Stage 2 (Phase III) - 3000 volunteers to be randomized to two groups - active drug and placebo in a ratio of 4: 1. Volunteers will receive the drug at the dose selected in the first phase. Research is carried out on an outpatient basis.
The randomization of research subjects will be carried out in two age strata: 12-14 years old and 15-17 years old.
The intramuscular vaccine will be administered at vaccination visits # 2 and # 3 (Day 1 and Day 21 ± 2) on an outpatient basis. After vaccination, TMK will be carried out for 2 days.
Follow-up visits # 4 (28 ± 2), 5 (42 ± 4), 6 (90 ± 7) and 7 (180 ± 14); TMK for 270 ± 14 and 365 ± 14 days.
Additionally historical control data will be used (data from phase III clinical trials of efficacy, safety and immunogenicity obtained during their evaluation in a sample of adult volunteers aged 18-21 years);
The duration of study participation for one subject will be 365 ± 14 days after the first dose of vaccine, during which each subject will undergo a screening visit, two hospitalizations for drug administration, five face-to-face visits to the investigator, and telephone contacts with the investigator.
The data of research subjects will be collected using electronic forms of individual registration cards, as well as using electronic questionnaires (diaries) filled in by research subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1/10 of full adult dose | Experimental | Biological: Gam-COVID-vac M |
| 1/5 of full adult dose | Experimental | Biological: Gam-COVID-vac M |
| Selected dose for second stage of the trial | Experimental | Biological: Gam-COVID-vac M |
| Placebo for second stage of the trial | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Availability of written informed consent of the research subject and parents / adoptive parents of the subject to participate in the research;
- Boys and girls aged 12-17 inclusive;
- Negative test result for HIV, hepatitis, syphilis;
- A negative test result for the presence of IgM and IgG antibodies to SARS CoV2 by enzyme immunoassay, as well as, if available, the result of an examination performed in medical institutions of the Moscow City Health Department 7 days prior to inclusion in the study can be taken into account;
- A negative test result for COVID-2019, determined by the PCR method at the screening visit, and, if available, can be taken into account the result of the examination performed in the medical organizations of the Moscow City Health Department 7 days before being included in the study;
Key exclusion criteria (28 listed)
- Any vaccination / immunization carried out within 30 days prior to enrollment in the study.
- Therapy with steroids (with the exception of hormonal contraceptive drugs) and / or immunoglobulins or other blood products, not completed 30 days before enrollment in the study;
- Immunosuppressive therapy and systemic therapy with corticosteroid drugs, completed in less than 3 months. prior to inclusion in the study.
- Postponed acute coronary syndrome or stroke less than one year before inclusion in the study
- Any immunodeficiency (for example, hereditary immunodeficiency, acquired immunodeficiency syndrome [AIDS], etc.).
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-vac MThe vaccine consists of two components: component I and component II. Component I includes a recombinant adenoviral vector based on human adenovirus serotype 26 carrying the gene for the S-protein of the SARS-CoV-2 virus, component II includes a vector based on human adenovirus serotype 5 carrying the protein S gene of the SARS-CoV-2 virus | Biological | 1/10 of full adult dose, 1/5 of full adult dose, Selected dose for second stage of the trial |
| PlaceboComposition without active ingredients | Biological | Placebo for second stage of the trial |
Primary outcome
Geometric mean titer of antigen-specific IgGs
Time frame: 21, 28, 42, 90, 180 days
To define geometric mean titer of antigen-specific IgGs after vaccination
Geometric mean titer of neutralizing antibodies
Time frame: 21, 28, 42, 90, 180 days
To define geometric mean titer of neutralizing antibodies against SARS-Cov-2 virus after vaccination
IFN-gamma secretion by T lymphocytes
Time frame: 21, 28, 42, 90, 180 days
To define changes in level of IFN-gamma secretion by T lymphocytes under antigen stimulation
Frequency of adverse reactions
Time frame: 365+/-14 days
Frequency of vaccine-related adverse reactions
Severity of adverse reactions
Time frame: 365+/-14 days
Severity of vaccine-related adverse reactions
1 secondary outcome
Incidence of COVID-19 cases
Time frame: within 28 to 365 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Derived from this study: PubMed 37600800Tukhvatulin AI, Dolzhikova IV, Dzharullaeva AS, Grousova DM, Kovyrshina AV, Zubkova OV, Zorkov ID, Iliukhina AA, Shelkov AY, Erokhova AS, Popova O, Ozharovskaia TA, Zrelkin DI, Izhaeva FM, Shcheblyakov DV, Esmagambetov IB, Tokarskaya EA, Nikitenko NA, Lubenets NL, Khadorich EA, Gushchin VA, Borzakova SN, Vlasova AV, Osmanov IM, Gorev VV, Naroditsky BS, Logunov DY, Gintsburg AL. Safety and immunogenicity of rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine against SARS-CoV-2 in healthy adolescents: an open-label, non-randomized, multicenter, phase 1/2, dose-escalation study. Front Immunol. 2023 Aug 1;14:1228461. doi: 10.3389/fimmu.2023.1228461. eCollection 2023.
- 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.
Anna Vlasova principal investigator
Morozovskaya Children's City Clinical Hospital of the Moscow Department of Health
Svetlana Borzakova principal investigator
Children's City Clinical Hospital named after Z.A. Bashlyaeva of the Moscow Department of Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Gam-COVID-vac M in people with Covid19 and Vaccine Preventable Disease, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation at 2 sites 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 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: status not confirmed, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
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?
Contact Nadezhda Lubenec (8 (499) 193-30-01, info@gamaleya.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric mean titer of antigen-specific IgGs (time frame: 21, 28, 42, 90, 180 days). The study lists 5 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 NCT04954092, 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 16 Sep 2021.