COVID-19 PreventionPhase 1/2NCT04713488
An Open Study on the Safety, Tolerability, and Immunogenicity of "Sputnik Light" Vaccine
A Phase 1/2 study testing Sputnik Light in people with COVID-19 Prevention, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation at 1 site in Russia.
Trial summary
Phase I-II open prospective, two-stage, non-randomized study in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 111 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Prevention
- What is being tested?
- Sputnik Light
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteRussia
- Study dates
- 15 Jan 2021to 31 Jul 2021
- 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 to 111 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent given by the subject to participate in the trial;
- Males and females aged 18 years old and older
- Lack of COVID-2019 in medical history: negative IgM and IgG SARS CoV2 antibodies enzyme-linked immunosorbent assay test result (no more than 14 days before being included in the trial)
- Negative COVID-2019 PCR test result during the screening visit
- No contact with COVID-2019-infected persons within at least 14 days before being included in the trial (according to what trial subjects state);
- Negative HIV and hepatitis test results;
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- Consent to use effective contraception methods during the trial
- Negative drugs or psychostimulants urine test during the screening visit;
- Negative alcohol test during the screening visit;
- Negative test for pregnancy (done for women with preserved reproductive potential)
- No evident vaccine-induced reactions or complications after receiving immunobiological products in the person's medical history;
- No acute infectious and/or respiratory diseases within at least 14 days before being included in the trial
Who cannot join
- Any vaccination / immunization performed within 14 days prior to enrollment in the study, or a planned vaccination within 14 days after being administered the study drug;
- Steroid therapy (except hormonal contraceptives or drugs used as hormone replacement therapy for menopause) that has not been completed 30 days before enrollment;
- Therapy with immunoglobulins or other blood products not completed 30 days before enrollment in the trial
- Immunosuppressor therapy that was completed within 3 months before being included in the trial
- A vaccination against COVID-2019 using any other drugs, including in the course of other clinical studies
- Female subjects during pregnancy or breastfeeding (for women with preserved reproductive potential);
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- Acute coronary syndrome or stroke suffered less than one year before enrolling in the trial
- Tuberculosis, chronic systemic infections;
- Complicated allergic history (severe life-threatening allergic reactions), 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 enrolling in the trial;
- Neoplasms in a person's medical history (ICD codes C00-D09);
- Donated blood or plasma (450+ ml) within 2 months before enrollment;
- Splenectomy in the person's medical history;
- Neutropenia (absolute neutrophil count <1,000 mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin <80 g/L), immunodeficiency in the medical history within 6 months before the enrollment;
- Active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis B or C;
- Anorexia, protein deficiency of any origin;
- Large tattoos at the injection site (deltoid muscle area), which does not allow assessing the localized response to administering the study drug/placebo
- Alcohol or drug addiction in the person's medical history;
- Registered with a psychiatrist
- Participation in any other interventional clinical Trial within 90 days before the start of this trial
- Any other condition that the researching physician considers to be a hindrance to completing the trial as per the protocol;
- Research facility staff and other employees directly involved in the trial (research team members) and their families.
- Any related conditions that, in the opinion of the study physician, could serve as a hindrance to participating in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Study on the Safety, Tolerability, and Immunogenicity of "Sputnik Light" t Vaccine for Prevention of Coronavirus Infection Caused by the SARS-CoV-2 Viruso
Phase I-II open prospective, two-stage, non-randomized study in healthy volunteers.
Read the detailed description
Screening Period = up to 7 days All screening procedures must be executed within the shortest possible time frame before the scheduled date for Visit 1 (drug administration). The laboratory and instrumental examination data obtained within 14 days before the screening will be recorded as the screening data.
The trial will include 110 volunteers that will be administered the study drug. Outpatient observation will be done over the course of 4 visits: on day 10, 28, and 42 following drug administration Along with that, the study will be continued in accordance with the Protocol, accompanied by all the prescribed procedures and visits up to 180 days of observation.
Visit No. 0 (outpatient): screening Visit No. 1 (outpatient): vaccination Visits No. 2, 3, 4, 5, and 8: follow-up on days 10, 28, 42, 90, and180 after vaccination.
On days 120 and 150, visits 6 and 7 will be accomplished by telephone contact / telemedicine conference or, if necessary, in the form of an in-person visit.
Any volunteer who received a dose of the study drug will be registered as a trial participant, and his/her data will be used to help assess the drug's safety and tolerability.
- Conditions
- COVID-19 Prevention
- Being tested
- Sputnik Light
- Keywords
- COVID-19, vaccine, vector vaccine, Immunologic Factors, SARS-CoV-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sputnik LightBiological
Also called vector vaccine to help prevent the SARS-CoV-2-induced coronavirus infection
solution for intramuscular injection Composition for 1 dose (0.5 ml)
| Study group | Role | What they receive |
|---|---|---|
| Sputnik Light Vaccine | Experimental | solution for intramuscular injection Composition for 1 dose (0.5 ml): Active substance: recombinant serotype 26 adenoviral particles containing the SARS-CoV-2 S protein gene, in the amount of (1.0±0.5) x 10*11 particles per dose. Receives: Biological: Sputnik Light |
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
Determination of antibody levels against the SARS-CoV-2 glycoprotein S measured by an ELISA vs. baseline values
Measured: at days 0,10, 28, 42, 180
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 changing of virus neutralizing antibody titer from baseline scores and at day 28 and 42
Measured: at days 0, 28, 42
Changing of antigen-specific cellular immunity level
Determination of antigen-specific cellular immunity
Measured: at days 0, 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start15 Jan 2021
- Primary completion20 Jul 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PreventionStudies 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
- Not applicable
- Intervention model
- Single group
- 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
- Collaborators
- Russian Direct Investment Fund
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713488
- Sponsor's protocol ID
- 06 - Sputnik Light - 2020
- Status last verified
- Jan 2021
- First submitted
- 13 Jan 2021
- Last updated
- 2 Feb 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 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Study on the Safety, Tolerability, and Immunogenicity of "Sputnik Light" t Vaccine for Prevention of Coronavirus Infection Caused by the SARS-CoV-2 Viruso
- ClinicalTrials.gov ID
- NCT04713488
- Acronym / sponsor ID
- 06 - Sputnik Light - 2020
- Conditions
- COVID-19 Prevention
- Keywords
- COVID-19, vaccine, vector vaccine, Immunologic Factors, SARS-CoV-2
- Phase
- Phase 1/2
- 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
- Collaborators
- Russian Direct Investment Fund
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 20 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 19 Jan 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.
Phase I-II open prospective, two-stage, non-randomized study in healthy volunteers.
Detailed description
Screening Period = up to 7 days All screening procedures must be executed within the shortest possible time frame before the scheduled date for Visit 1 (drug administration). The laboratory and instrumental examination data obtained within 14 days before the screening will be recorded as the screening data.
The trial will include 110 volunteers that will be administered the study drug. Outpatient observation will be done over the course of 4 visits: on day 10, 28, and 42 following drug administration Along with that, the study will be continued in accordance with the Protocol, accompanied by all the prescribed procedures and visits up to 180 days of observation.
Visit No. 0 (outpatient): screening Visit No. 1 (outpatient): vaccination Visits No. 2, 3, 4, 5, and 8: follow-up on days 10, 28, 42, 90, and180 after vaccination.
On days 120 and 150, visits 6 and 7 will be accomplished by telephone contact / telemedicine conference or, if necessary, in the form of an in-person visit.
Any volunteer who received a dose of the study drug will be registered as a trial participant, and his/her data will be used to help assess the drug's safety and tolerability.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sputnik Light Vaccine | Experimental | Biological: Sputnik Lightsolution for intramuscular injection Composition for 1 dose (0.5 ml): Active substance: recombinant serotype 26 adenoviral particles containing the SARS-CoV-2 S protein gene, in the amount of (1.0±0.5) x 10*11 particles per dose. |
Who may qualify
- Ages
- 18 to 111 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Written informed consent given by the subject to participate in the trial;
- Males and females aged 18 years old and older
- Lack of COVID-2019 in medical history: negative IgM and IgG SARS CoV2 antibodies enzyme-linked immunosorbent assay test result (no more than 14 days before being included in the trial)
- Negative COVID-2019 PCR test result during the screening visit
- No contact with COVID-2019-infected persons within at least 14 days before being included in the trial (according to what trial subjects state);
Key exclusion criteria (22 listed)
- Any vaccination / immunization performed within 14 days prior to enrollment in the study, or a planned vaccination within 14 days after being administered the study drug;
- Steroid therapy (except hormonal contraceptives or drugs used as hormone replacement therapy for menopause) that has not been completed 30 days before enrollment;
- Therapy with immunoglobulins or other blood products not completed 30 days before enrollment in the trial
- Immunosuppressor therapy that was completed within 3 months before being included in the trial
- A vaccination against COVID-2019 using any other drugs, including in the course of other clinical studies
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 |
|---|---|---|
| Sputnik LightAlso: vector vaccine to help prevent the SARS-CoV-2-induced coronavirus infectionsolution for intramuscular injection Composition for 1 dose (0.5 ml) | Biological | Sputnik Light Vaccine |
Primary outcome
Changing of antibody levels against the SARS-CoV-2 glycoprotein S
Time frame: at days 0,10, 28, 42, 180
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: at days 0, 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sputnik Light in people with COVID-19 Prevention, 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 12 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 2 Feb 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 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?
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 (time frame: at days 0,10, 28, 42, 180). 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 2 Feb 2021.