COVID-19Phase 1/2SPRAYNCT05248373
Safety, Tolerability and Immunogenicity of Gam-COVID-Vac Vaccine in a Nasal Spray
A Phase 1/2 study testing Gam-COVID-Vac in people with COVID-19 and SARS-CoV-2 Acute Respiratory Disease, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation.
Trial summary
Randomized, double-blind, placebo-controlled trial to evaluate safety and immunogenicity of intranasal "Gam-COVID-Vak" combined vector vaccine for the prevention of coronavirus infection caused by the SARS-CoV-2 virus. 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, SARS-CoV-2 Acute Respiratory Disease
- What is being tested?
- Gam-COVID-Vac
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 8 Mar 2022to 30 Dec 2023
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The presence of a written informed consent of the subject to participate in the study;
- Adult volunteers over 18;
- Negative test result for HIV, hepatitis, syphilis;
- Negative test result for COVID-2019, determined by PCR at the visit screening, and, if available, the result of the examination performed in medical organizations that are research centers 7 days before inclusion into research;
- The result of the study for the presence of IgG antibodies to SARS CoV2 up to 10 VGR, which corresponds to value up to 100 BAU, regardless of the immune status before;
- Absence of contact of the research subject with patients with COVID-2019 for at least 14 days before enrollment in the study (according to the study participant);
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- Consent to use effective methods of contraception during the entire period of participation in research;
- Negative Urine Pregnancy Test at Screening Visit (for women of childbearing age);
- Negative test for the presence of narcotic and psychostimulant drugs in the urine for screening visit;
- Negative alcohol test at screening visit;
- No history of severe post-vaccination reactions or post-vaccination complications after the use of immunobiological preparations;
- Absence of acute infectious and/or respiratory diseases for at least within 14 days prior to enrollment in the study.
Who cannot join
- Inability to give informed consent, inability to understand the essence of the study
- Any vaccination/immunization carried out within 30 days prior to inclusion in study;
- Steroid therapy (excluding hormonal contraceptives) and/or immunoglobulins or other blood products, not completed 30 days before inclusion in the study;
- COVID-2019 disease or vaccination to prevent COVID-2019 in less than six months before inclusion in the study
- Immunosuppressive drug therapy completed less than 3 months before inclusion in the study;
- Postponed less than one year prior to enrollment in the study acute coronary syndrome or stroke;
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- Tuberculosis, chronic systemic infections;
- Exacerbation of rhinitis
- Burdened allergic history (presence in the anamnesis of information about anaphylactic shock, angioedema, polymorphic exudative eczema, serum sickness), hypersensitivity or allergic reactions to the introduction of immunobiological drugs, known allergic reactions to drug components, exacerbation allergic diseases on the day of inclusion in the study;
- History of neoplasms (ICD codes C00-D09);
- Donation of blood or plasma (in a volume of 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), immunodeficiency in history within 6 months prior to enrollment in the study;
- Subjects with active human immunodeficiency virus disease syphilis, hepatitis B and C;
- Anorexia, protein deficiency of any origin;
- History of alcoholism and drug addiction;
- Participation of the subject in any other interventional clinical trial during this study;
- Any other condition of the research subject that, in the opinion of the research physician, may prevent completion of the study in accordance with the protocol;
- Staff of research centers and other staff directly involved in conducting the study (principal investigator and members of the research team) and members of their families.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Double-blind Placebo-controlled Multi-center Clinical Trial in Parallel Assignment of Safety, Tolerability and Immunogenicity of a Vaccine "Gam-COVID-Vac, a Combined Vector Vaccine for the Prevention of Coronavirus Infection Caused by the SARS-CoV-2 Virus" in a Nasal Spray Dosage Form With the Participation of Adult Volunteers
Randomized, double-blind, placebo-controlled trial to evaluate safety and immunogenicity of intranasal "Gam-COVID-Vak" combined vector vaccine for the prevention of coronavirus infection caused by the SARS-CoV-2 virus.
The duration of participation in the study for one subject will be 180±14 days after the first dose of vaccine, during which each subject will undergo a screening visit (within a week) and face-to-face visits according to the study plan. Intranasal vaccine administration will be done at day 1 vaccination visits and day 21±2 days on an outpatient basis.
Read more
During the follow-up visits key vital signs will be assessed, and will collect data on changes in the state and well-being subjects from a previous visit. Subject data will be collected using electronic forms of individual registration cards, as well as with using questionnaires (diaries) filled by the subjects of the study.
Immunogenicity will be assessed on day 1, 10, 28, 42 and 90 days. Humoral and cellular immune response will be evaluated.
- Conditions
- COVID-19, SARS-CoV-2 Acute Respiratory Disease
- Being tested
- Gam-COVID-Vac, Placebo
- Keywords
- vaccine, Sputnik, adenoviral vector vaccine, intranasal vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gam-COVID-VacBiological
two-component combined vector vaccine for the prevention of coronavirus infection caused by the SARS-CoV-2 virus
PlaceboOther
solution with same composition as for vaccine formulation except rAds
| Study group | Role | What they receive |
|---|---|---|
| rAd26 single administration | Experimental | Not described Receives: Biological: Gam-COVID-Vac |
| rAd5 single administration | Experimental | Not described Receives: Biological: Gam-COVID-Vac |
| prime-boost regimen with rAd26 followed rAd5 administration | Experimental | Not described Receives: Biological: Gam-COVID-Vac |
| placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in geometric mean titer of IgGs specific to S protein
Change from baseline in Geometric mean titer of IgGs specific to S protein at different time points after vaccination
Measured: 0, 10, 28, 42, 90 day
Change from baseline in number of participants with detected specific IgGs
Change from baseline in Number of participants with detected specific IgGs at different time points after vaccination
Measured: 0, 10, 28, 42, 90 day
Change from baseline in Number of participants with detected specific IgAs
Change from baseline in Number of participants with detected specific IgAs at different time points after vaccination
Measured: 0, 10, 28, 42 day
Change from baseline in Geometric mean titer of neutralizing antibodies to SARS-Cov-2 virus
Change from baseline in Geometric mean titer of neutralizing antibodies to SARS-Cov-2 virus at different time points after vaccination
Measured: 0, 28, 42, 90 day
Change from baseline in Number of participants with detected neutralizing antibodies to SARS-Cov-2 virus
Change from baseline in Number of participants with detected neutralizing antibodies to SARS-Cov-2 virus at different time points after vaccination
Measured: 0, 28, 42, 90 day
Proportion of participants with any adverse events
AEs evaluation during the whole period of the study
Measured: 1-180 days
Proportion of participants with severe adverse events
SAEs evaluation during the whole period of the study
Measured: 1-180 days
Secondary outcomes (1)
Efficacy of symptomatic COVID-19 prevention
Efficacy of symptomatic COVID-19 prevention
Measured: 28-180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start8 Mar 2022 (estimated)
- Primary completion14 Feb 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 400 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
- NCT05248373
- Sponsor's protocol ID
- SPRAY vaccine against COVID-19
- Acronym
- SPRAY
- Status last verified
- Mar 2022
- First submitted
- 7 Feb 2022
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind Placebo-controlled Multi-center Clinical Trial in Parallel Assignment of Safety, Tolerability and Immunogenicity of a Vaccine "Gam-COVID-Vac, a Combined Vector Vaccine for the Prevention of Coronavirus Infection Caused by the SARS-CoV-2 Virus" in a Nasal Spray Dosage Form With the Participation of Adult Volunteers
- ClinicalTrials.gov ID
- NCT05248373
- Acronym / sponsor ID
- SPRAY / SPRAY vaccine against COVID-19
- Conditions
- COVID-19, SARS-CoV-2 Acute Respiratory Disease
- Keywords
- vaccine, Sputnik, adenoviral vector vaccine, intranasal vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian FederationUniversity, hospital or other
- Study start
- 8 Mar 2022 (estimated)
- Primary completion
- 14 Feb 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 21 Feb 2022 (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.
Randomized, double-blind, placebo-controlled trial to evaluate safety and immunogenicity of intranasal "Gam-COVID-Vak" combined vector vaccine for the prevention of coronavirus infection caused by the SARS-CoV-2 virus.
The duration of participation in the study for one subject will be 180±14 days after the first dose of vaccine, during which each subject will undergo a screening visit (within a week) and face-to-face visits according to the study plan. Intranasal vaccine administration will be done at day 1 vaccination visits and day 21±2 days on an outpatient basis.
During the follow-up visits key vital signs will be assessed, and will collect data on changes in the state and well-being subjects from a previous visit. Subject data will be collected using electronic forms of individual registration cards, as well as with using questionnaires (diaries) filled by the subjects of the study.
Immunogenicity will be assessed on day 1, 10, 28, 42 and 90 days. Humoral and cellular immune response will be evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| rAd26 single administration | Experimental | Biological: Gam-COVID-Vac |
| rAd5 single administration | Experimental | Biological: Gam-COVID-Vac |
| prime-boost regimen with rAd26 followed rAd5 administration | Experimental | Biological: Gam-COVID-Vac |
| placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- The presence of a written informed consent of the subject to participate in the study;
- Adult volunteers over 18;
- Negative test result for HIV, hepatitis, syphilis;
- Negative test result for COVID-2019, determined by PCR at the visit screening, and, if available, the result of the examination performed in medical organizations that are research centers 7 days before inclusion into research;
- The result of the study for the presence of IgG antibodies to SARS CoV2 up to 10 VGR, which corresponds to value up to 100 BAU, regardless of the immune status before;
Key exclusion criteria (19 listed)
- Inability to give informed consent, inability to understand the essence of the study
- Any vaccination/immunization carried out within 30 days prior to inclusion in study;
- Steroid therapy (excluding hormonal contraceptives) and/or immunoglobulins or other blood products, not completed 30 days before inclusion in the study;
- COVID-2019 disease or vaccination to prevent COVID-2019 in less than six months before inclusion in the study
- Immunosuppressive drug therapy completed less than 3 months before 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 |
|---|---|---|
| Gam-COVID-Vactwo-component combined vector vaccine for the prevention of coronavirus infection caused by the SARS-CoV-2 virus | Biological | prime-boost regimen with rAd26 followed rAd5 administration, rAd26 single administration, rAd5 single administration |
| Placebosolution with same composition as for vaccine formulation except rAds | Other | placebo |
Primary outcome
Change from baseline in geometric mean titer of IgGs specific to S protein
Time frame: 0, 10, 28, 42, 90 day
Change from baseline in Geometric mean titer of IgGs specific to S protein at different time points after vaccination
Change from baseline in number of participants with detected specific IgGs
Time frame: 0, 10, 28, 42, 90 day
Change from baseline in Number of participants with detected specific IgGs at different time points after vaccination
Change from baseline in Number of participants with detected specific IgAs
Time frame: 0, 10, 28, 42 day
Change from baseline in Number of participants with detected specific IgAs at different time points after vaccination
Change from baseline in Geometric mean titer of neutralizing antibodies to SARS-Cov-2 virus
Time frame: 0, 28, 42, 90 day
Change from baseline in Geometric mean titer of neutralizing antibodies to SARS-Cov-2 virus at different time points after vaccination
Change from baseline in Number of participants with detected neutralizing antibodies to SARS-Cov-2 virus
Time frame: 0, 28, 42, 90 day
Change from baseline in Number of participants with detected neutralizing antibodies to SARS-Cov-2 virus at different time points after vaccination
Proportion of participants with any adverse events
Time frame: 1-180 days
AEs evaluation during the whole period of the study
Proportion of participants with severe adverse events
Time frame: 1-180 days
SAEs evaluation during the whole period of the study
1 secondary outcome
Efficacy of symptomatic COVID-19 prevention
Time frame: 28-180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Gam-COVID-Vac in people with COVID-19 and SARS-CoV-2 Acute Respiratory Disease, 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 12 inclusion and 19 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 8 Mar 2022. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Nadezhda L 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?
Change from baseline in geometric mean titer of IgGs specific to S protein (time frame: 0, 10, 28, 42, 90 day). The study lists 7 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 8 Mar 2022.