COVID-19Phase 3NCT06057025
Study of "Sputnik Lite" for the Prevention of COVID-19 With Altered Antigenic Composition.
A Phase 3 study testing "Sputnik Lite" 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 drug "Sputnik Lite" for the prevention of coronavirus infection caused by the SARS-CoV-2 virus with altered antigenic composition with participation of adult volunteers. 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
- What is being tested?
- "Sputnik Lite" 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
- Sep 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The study will include volunteers who meet all the specified criteria:
- Subject's written informed consent to participate in the study;
- Adult volunteer's men and women over 18 years old;
- A negative test result for COVID-19, determined by PCR or express method before the introduction of the investigational medicinal product (IMP).
- 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);
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- Negative test for the presence of narcotic and psychostimulants in the urine at the screening visit;
- Negative alcohol content test at the screening visit;
- No contraindications to vaccination;
- 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:
- No signed informed consent to participate 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 before inclusion in the study;
- Female subjects during pregnancy or lactation;
- Acute coronary syndrome or stroke suffered less than one year before inclusion in the study;
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- Tuberculosis, chronic systemic infections according to anamnesis;
- Burdened allergic anamnesis (the presence in the anamnesis of information about anaphylactic shock, Quincke's edema, polymorphic exudative eczema, serum sickness), hypersensitivity or allergic reactions to the administration 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 neoplasms (ICD codes C00-D09) (according to the anamnesis);
- Splenectomy (according to the anamnesis);
- 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 - 6 months prior to inclusion in the study (according to the anamnesis);
- Subjects with an active form of the disease caused by human immunodeficiency virus, syphilis, hepatitis B and C (according to anamnesis);
- Anorexia, protein deficiency of any origin;
- Alcoholism and drug addiction (according to anamnesis);
- The subject's participation in any other interventional clinical trial (with the exception of rescreening in the current study) in the last 90 days;
- 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);
- Any other condition of the subject of the study, which, in the opinion of the research doctor, may prevent the completion of the study in accordance with the protocol;
- Vaccination against COVID-19 or transmitted coronavirus infection COVID-19 less than 6 months before screening;
- Repeated administration of the Sputnik V vaccine, Sputnik Lite, or repeated administration of any other COVID-19 vaccine for more than three injections (Sputnik V vaccination plus Sputnik Lite revaccination);
- 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 the volunteer to participate in the study, affect the ability of the volunteer to participate in the study;
- Staff of research centers (chief researcher and members of the research team) directly involved in the research and their family members.
About this study
Official title: Safety, Reactogenicity and Immunogenicity Study of the Drug "Sputnik Lite" for the Prevention of Coronavirus (COVID-19) Infection Caused by the SARS-CoV-2 Virus With Altered Antigenic Composition With Participation of Adult Volunteers.
Safety, reactogenicity and immunogenicity study of the drug "Sputnik Lite" for the prevention of coronavirus infection caused by the SARS-CoV-2 virus with altered antigenic composition with participation of adult volunteers.
- Conditions
- COVID-19
- Being tested
- "Sputnik Lite" 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.
"Sputnik Lite" vaccine for the prevention of COVID-19 with altered antigenic compositionBiological
Single intramuscular injection of "Sputnik Lite" vaccine for the prevention of COVID-19 with altered antigenic composition.
| Study group | Role | What they receive |
|---|---|---|
| Healthy patients | Experimental | Drug: Sputnik Light vector vaccine for the prevention of coronavirus infection caused by the SARS CoV-2 virus (with altered antigenic composition); A total of 50 people will be randomized and receive the study drug. A single intramuscular injection of the investigational medicinal product (IMP) will be performed. Receives: Biological: "Sputnik Lite" 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 28 days after administration of the drug
Occurrence of serious adverse events (SAEs)
Occurrence of serious adverse events (SAEs)
Measured: Throughout Study completion, until December 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study startSep 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.
- 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
- NCT06057025
- Sponsor's protocol ID
- 14-Sputnik Lite / N-2023
- Status last verified
- Sep 2023
- First submitted
- 21 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Reactogenicity and Immunogenicity Study of the Drug "Sputnik Lite" for the Prevention of Coronavirus (COVID-19) Infection Caused by the SARS-CoV-2 Virus With Altered Antigenic Composition With Participation of Adult Volunteers.
- ClinicalTrials.gov ID
- NCT06057025
- Acronym / sponsor ID
- 14-Sputnik Lite / 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
- Sep 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 28 Sep 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 drug "Sputnik Lite" for the prevention of coronavirus infection caused by the SARS-CoV-2 virus with altered antigenic composition with participation of adult 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: "Sputnik Lite" vaccine for the prevention of COVID-19 with altered antigenic compositionDrug: Sputnik Light vector vaccine for the prevention of coronavirus infection caused by the SARS CoV-2 virus (with altered antigenic composition); A total of 50 people will be randomized and receive the study drug. A single intramuscular injection of the investigational medicinal product (IMP) will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject's written informed consent to participate in the study;
- Adult volunteer's men and women over 18 years old;
- A negative test result for COVID-19, determined by PCR or express method before the introduction of the investigational medicinal product (IMP).
- 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);
Key exclusion criteria (22 listed)
- Volunteers cannot be included in the study if there is at least one of the following criteria for non-inclusion:
- No signed informed consent to participate 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 before inclusion in the study;
- Female subjects during pregnancy or lactation;
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 Lite" vaccine for the prevention of COVID-19 with altered antigenic compositionSingle intramuscular injection of "Sputnik Lite" vaccine for the prevention of COVID-19 with altered antigenic composition. | Biological | Healthy patients |
Primary outcome
Occurrence of adverse events (AE)
Time frame: Within 28 days after administration of the drug
Occurrence of adverse events (AE)
Occurrence of serious adverse events (SAEs)
Time frame: Throughout Study completion, until December 2024
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 28 Sep 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.
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 "Sputnik Lite" 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 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 28 Sep 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 28 days after 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?
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 28 Sep 2023.