COVID-19 PreventionPhase 3SPUTNIK-LIGHTNCT04741061
Study to Evaluate Efficacy, Immunogenicity and Safety of the Sputnik-Light
A Phase 3 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 15 sites in Russia.
Trial summary
The study Global sponsor is planning several parallel studies of Sputnik-Light vector vaccine across the globe in United Arab Emirates, Russia and possibly in other countries in case of confirmation associated with the same medical product under similar protocols. 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6,000 participants
- Where
- 15 sitesRussia
- Study dates
- 19 Feb 2021to 31 Jan 2022
- 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 to 111 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Agree to sign the study informed consent form (ICF) before performing any study specific procedure
- Adults ≥ 18 years old
- Negative COVID-19 PCR test result at the screening visit and negative immunochromatographic SARS-CoV-2 antigen rapid-test result at the enrolment
- Consent for using effective methods of contraception during the study
- No evidence of vaccine-induced reactions or complications after receiving immunobiological products in medical history
- No acute infectious and/or respiratory diseases within at least 14 days before the enrolment
Who cannot join
- Any previous vaccination/immunization (within 30 days before the enrollment) and any planned vaccination within 30 days after enrollment
- Any previous or planning COVID-19 vaccination with any other Regulatory approved vaccine
- Positive SARS-CoV-2 screening result obtained by PCR (at screening)
- Administration of steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrollment
- Pregnancy or lactation
- Acute coronary syndrome or stroke suffered less than one year before study enrollment
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- Tuberculosis, chronic systemic infections associated with Immunocompromised subjects in medical history
- History of severe allergic reaction to drug or vaccine (anaphylactic shock, Quincke's edema, and other life-threatening allergic reactions), acute exacerbation of allergic diseases on screening and vaccination day
- Chronic autoimmune disease and system collagenases in medical history
- Organ transplantation and immunosuppressive therapy
- Immunosuppressive therapy and corticosteroid system therapy within 3 months before the enrollment
- Subjects with malignant neoplasms within 5 years before the enrollment
- Splenectomy in the past medical history
- Neutropenia (absolute neutrophil count <1,000 mm3 agranulocytosis, significant blood loss, severe anemia (hemoglobin <80 g/L), immunodeficient disease in the medical history within 6 months before the enrollment
- The active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis B, or C
- Acute Kidney injury or dialysis
- Anorexia or dysnutrition
- Tattoos at the injection site (deltoid muscle area), which in the medical opinion of the investigator does not allow assessing the local response to the vaccine/placebo
- Alcohol or Drug abuse in medical history
- Participation in other interventional clinical trial within the previous 90 days prior to vaccination and over duration of the trial
- Any other condition that the investigator considers as a barrier to the trial completion as per the protocol
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Russia15 sites, 15 recruiting
- Not yet recruiting
Federal State Autonomous Educational Institution for Higher Education "Immanuel Kant Baltic Federal University"
Kaliningrad
Vladimir Rafalskiy
Vladimir Rafalskiy
- Recruiting
State Budgetary Healthcare Institution, Moscow, Consultation and Diagnosis Polyclinic No. 121, Moscow Healthcare Department
Moscow
Elena Klimova, MD
- Recruiting
State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 210, Moscow Healthcare Department
Moscow
Anna Gratzianskaya
- Recruiting
State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 219, Moscow Healthcare Department
Moscow
Natalia Nenasheva, MD
- Not yet recruiting
State budgetary institution of health care of the city of Moscow "diagnostic centre № 5 associated with policlinic department of Moscow Healthcare Department"
Moscow
Tamara Vilegzhanina
Tamara Vilegzhanina
- Recruiting
State budgetary institution of health care of the city of Moscow "diagnostic clinical centre № 1 Moscow Healthcare Department "
Moscow
Natalia Shartanova
Natalia Shartanova
- Recruiting
State budgetary institution of health care of the city of Moscow "Municipal Polyclinic № 2 Moscow Healthcare Department"
Moscow
Sergey Fitilev, MD
Sergey Fitilev
- Recruiting
State budgetary institution of health care of the city of Moscow "Municipal Polyclinic № 36 Moscow Healthcare Department"
Moscow
Irina Isakova
Irina Isakova
- Not yet recruiting
State budgetary institution of health care of the city of Moscow "Municipal Polyclinic № 6 Moscow Healthcare Department"
Moscow
Marina Ivzhits
Marina Ivzhits
- Recruiting
State budgetary institution of health care of the city of Moscow "Municipal Polyclinic № 62 Moscow Healthcare Department"
Moscow
Marina Rusanova, MD, PhD
Marina Rusanova
- Recruiting
State budgetary institution of health care of the city of Moscow "Municipal Polyclinic № 64 Moscow Healthcare Department"
Moscow
Svetlana Rachina
Svetlana Rachina
- Not yet recruiting
St. Petersburg's state budgetary health care Institution "Municipal hospital № 40 of Kurortniy area"
Saint Petersburg
Alina Agafina, MD
Alina Agafina
- Not yet recruiting
St. Petersburg's state budgetary health care Institution "Municipal hospital №117"
Saint Petersburg
Diana Alpenidze
Diana Alpenidze
- Not yet recruiting
Federal state budgetary educational Institution for Higher Education "Saratov State Medical University named after V.I. Razumovskiy" Ministry of Health of Russian Federation
Saratov
Yury Shvarts
Yury Shvarts
- Not yet recruiting
LLC "Uromed"
Smolensk
Alla Andreeva
Alla Andreeva
About this study
Official title: A Phase III, Randomized, Double-blind, Placebo-controlled International Multicenter Study to Evaluate Efficacy, Immunogenicity and Safety of the Sputnik-Light Vector Vaccine in the Parallel Assignment of the Subjects in Prophylactic Treatment for SARS-СoV-2 Infection
The study Global sponsor is planning several parallel studies of Sputnik-Light vector vaccine across the globe in United Arab Emirates, Russia and possibly in other countries in case of confirmation associated with the same medical product under similar protocols. The key objective of this study is to be conducted in several parallel studies of the same vaccine above the other countries. Using similar protocols on a portfolio basis of studies let us collect data for Efficacy, Immunogenicity, Safety and Tolerability confirmation of the Sputnik-Light vaccine.
Read the detailed description
This study is randomized, double-blind (blinded for the study subject and investigators), placebo-controlled international multicenter study in the parallel assignment of the subjects to assess efficacy, immunogenicity and safety of the Sputnik-Light vector vaccine in adults in the SARS-СoV-2 infection prophylactic treatment
The subjects will be randomized into two groups in the ratio of 1:3; a control group (1500 subjects receiving placebo) and a study group (4500 subjects receiving the Sputnik-Light vector vaccine against the SARS-СoV-2-induced COVID19 infection).
For the evaluation of immunogenicity an unbalanced design is adopted of the placebo and vaccinated group at a 1:3 ratio. Subsequently the number of subjects in Subgroup A tested will be 1076 subjects, distributed as follows: 269 in the placebo group and 807 in the vaccinated group, also randomized into two groups in the ratio of 1:3 who will attend for assessment of immunogenicity compared to baseline.
Each subjects will participate in the trial for approximately 6 months after the first dose of the study vaccine/placebo and will have at least tree on-site visits, including a screening visit to the study clinical site during the study period and several observation Phone Call/ Tele-consultation visits during the study
- Conditions
- COVID-19 Prevention
- Being tested
- Sputnik Light, Placebo
- Keywords
- COVID-19, vaccine, vector vaccine, adenovirus vector, 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
Sputnik-Light vector vaccine:
Active substance: recombinant adenovirus serotype 26 particles containing the SARS-CoV-2 protein S gene, in the amount of (1.0±0.5) х 1011 particles per dose.
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Sputnik Light Vaccine | Active comparator | study group (4500 receiving the Sputnik-Light vector vaccine) against the SARS-СoV-2-induced coronavirus infection. Receives: Biological: Sputnik Light |
| Placebo Group | Placebo comparator | control group (1500 subjects receiving placebo) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events in study subjects
Incidence and severity of AEs and SAEs during the subject's participation in the study
Measured: through the whole study, an average of 180 days
Percentage of study subjects with COVID-19 cases developed after vaccination
Percentage of study subjects with COVID-19 cases developed after vaccination with the Sputnik-Light vector vaccine as compared with placebo
Measured: through the whole study, an average of 180 days
Secondary outcomes (2)
Humoral immunogenicity (Quantitative IgG antibodies to SARS-CoV-2 S Protein)
Geometric mean titer (GMT) levels of Quantitative IgG antibodies
Measured: at days 0, 42, 180
Humoral immunogenicity (IgG SARS-CoV-2 N-antibodies)
Percentage of study subjects who have a post-treatment response as measures with Qualitative IgG SARS-CoV-2 N-antibodies
Measured: at days 0, 42, 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start19 Feb 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Jan 2022 (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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double-blind (blinded for the study subject and investigators), placebo-controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6,000 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
- Russian Direct Investment Fund, CRO: iPharma, Government of the city of Moscow
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741061
- Sponsor's protocol ID
- 01 - Sputnik Light - 2021
- Acronym
- SPUTNIK-LIGHT
- Status last verified
- Feb 2021
- First submitted
- 2 Feb 2021
- Last updated
- 21 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 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-blind, Placebo-controlled International Multicenter Study to Evaluate Efficacy, Immunogenicity and Safety of the Sputnik-Light Vector Vaccine in the Parallel Assignment of the Subjects in Prophylactic Treatment for SARS-СoV-2 Infection
- ClinicalTrials.gov ID
- NCT04741061
- Acronym / sponsor ID
- SPUTNIK-LIGHT / 01 - Sputnik Light - 2021
- Conditions
- COVID-19 Prevention
- Keywords
- COVID-19, vaccine, vector vaccine, adenovirus vector, SARS-CoV-2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian FederationUniversity, hospital or other
- Collaborators
- Russian Direct Investment Fund, CRO: iPharma, Government of the city of Moscow
- Study start
- 19 Feb 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 5 Feb 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.
The study Global sponsor is planning several parallel studies of Sputnik-Light vector vaccine across the globe in United Arab Emirates, Russia and possibly in other countries in case of confirmation associated with the same medical product under similar protocols. The key objective of this study is to be conducted in several parallel studies of the same vaccine above the other countries. Using similar protocols on a portfolio basis of studies let us collect data for Efficacy, Immunogenicity, Safety and Tolerability confirmation of the Sputnik-Light vaccine.
Detailed description
This study is randomized, double-blind (blinded for the study subject and investigators), placebo-controlled international multicenter study in the parallel assignment of the subjects to assess efficacy, immunogenicity and safety of the Sputnik-Light vector vaccine in adults in the SARS-СoV-2 infection prophylactic treatment
The subjects will be randomized into two groups in the ratio of 1:3; a control group (1500 subjects receiving placebo) and a study group (4500 subjects receiving the Sputnik-Light vector vaccine against the SARS-СoV-2-induced COVID19 infection).
For the evaluation of immunogenicity an unbalanced design is adopted of the placebo and vaccinated group at a 1:3 ratio. Subsequently the number of subjects in Subgroup A tested will be 1076 subjects, distributed as follows: 269 in the placebo group and 807 in the vaccinated group, also randomized into two groups in the ratio of 1:3 who will attend for assessment of immunogenicity compared to baseline.
Each subjects will participate in the trial for approximately 6 months after the first dose of the study vaccine/placebo and will have at least tree on-site visits, including a screening visit to the study clinical site during the study period and several observation Phone Call/ Tele-consultation visits during the study
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- randomized, double-blind (blinded for the study subject and investigators), placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Sputnik Light Vaccine | Active comparator | Biological: Sputnik Lightstudy group (4500 receiving the Sputnik-Light vector vaccine) against the SARS-СoV-2-induced coronavirus infection. |
| Placebo Group | Placebo comparator | Other: Placebocontrol group (1500 subjects receiving placebo) |
Who may qualify
- Ages
- 18 to 111 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Agree to sign the study informed consent form (ICF) before performing any study specific procedure
- Adults ≥ 18 years old
- Negative COVID-19 PCR test result at the screening visit and negative immunochromatographic SARS-CoV-2 antigen rapid-test result at the enrolment
- Consent for using effective methods of contraception during the study
- No evidence of vaccine-induced reactions or complications after receiving immunobiological products in medical history
Key exclusion criteria (21 listed)
- Any previous vaccination/immunization (within 30 days before the enrollment) and any planned vaccination within 30 days after enrollment
- Any previous or planning COVID-19 vaccination with any other Regulatory approved vaccine
- Positive SARS-CoV-2 screening result obtained by PCR (at screening)
- Administration of steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrollment
- 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 LightSputnik-Light vector vaccine: Active substance: recombinant adenovirus serotype 26 particles containing the SARS-CoV-2 protein S gene, in the amount of (1.0±0.5) х 1011 particles per dose. | Biological | Sputnik Light Vaccine |
| PlaceboPlacebo | Other | Placebo Group |
Primary outcome
Incidence and severity of adverse events in study subjects
Time frame: through the whole study, an average of 180 days
Incidence and severity of AEs and SAEs during the subject's participation in the study
Percentage of study subjects with COVID-19 cases developed after vaccination
Time frame: through the whole study, an average of 180 days
Percentage of study subjects with COVID-19 cases developed after vaccination with the Sputnik-Light vector vaccine as compared with placebo
2 secondary outcomes
Humoral immunogenicity (Quantitative IgG antibodies to SARS-CoV-2 S Protein)
Time frame: at days 0, 42, 180
Humoral immunogenicity (IgG SARS-CoV-2 N-antibodies)
Time frame: at days 0, 42, 180
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 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.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 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 15 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 6 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 21 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 15 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 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?
Contact Elena Merkulova (+7 (495) 276 11 43 ext. 495, eam@ipharma.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events in study subjects (time frame: through the whole study, an average of 180 days). 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 21 Feb 2021.