Study to Evaluate Efficacy, Immunogenicity and Safety of the Sputnik-Light
NCT ID: NCT04741061
Last Updated: 2021-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
6000 participants
INTERVENTIONAL
2021-02-19
2022-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Sputnik Light Vaccine
study group (4500 receiving the Sputnik-Light vector vaccine) against the SARS-СoV-2-induced coronavirus infection.
Sputnik Light
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.
Placebo Group
control group (1500 subjects receiving placebo)
Placebo
Placebo
Interventions
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Sputnik Light
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.
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Adults ≥ 18 years old
3. Negative COVID-19 PCR test result at the screening visit and negative immunochromatographic SARS-CoV-2 antigen rapid-test result at the enrolment
4. Consent for using effective methods of contraception during the study
5. No evidence of vaccine-induced reactions or complications after receiving immunobiological products in medical history
6. No acute infectious and/or respiratory diseases within at least 14 days before the enrolment
Exclusion Criteria
2. Any previous or planning COVID-19 vaccination with any other Regulatory approved vaccine
3. Positive SARS-CoV-2 screening result obtained by PCR (at screening)
4. Administration of steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrollment
5. Pregnancy or lactation
6. Acute coronary syndrome or stroke suffered less than one year before study enrollment
7. Tuberculosis, chronic systemic infections associated with Immunocompromised subjects in medical history
8. 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
9. Chronic autoimmune disease and system collagenases in medical history
10. Organ transplantation and immunosuppressive therapy
11. Immunosuppressive therapy and corticosteroid system therapy within 3 months before the enrollment
12. Subjects with malignant neoplasms within 5 years before the enrollment
13. Splenectomy in the past medical history
14. 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
15. The active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis B, or C
16. Acute Kidney injury or dialysis
17. Anorexia or dysnutrition
18. 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
19. Alcohol or Drug abuse in medical history
20. Participation in other interventional clinical trial within the previous 90 days prior to vaccination and over duration of the trial
21. Any other condition that the investigator considers as a barrier to the trial completion as per the protocol
18 Years
111 Years
ALL
Yes
Sponsors
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Russian Direct Investment Fund
INDUSTRY
CRO: iPharma
UNKNOWN
Government of the city of Moscow
UNKNOWN
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
OTHER
Responsible Party
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Locations
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Federal State Autonomous Educational Institution for Higher Education "Immanuel Kant Baltic Federal University"
Kaliningrad, , Russia
State Budgetary Healthcare Institution, Moscow, Consultation and Diagnosis Polyclinic No. 121, Moscow Healthcare Department
Moscow, , Russia
State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 210, Moscow Healthcare Department
Moscow, , Russia
State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 219, Moscow Healthcare Department
Moscow, , Russia
State budgetary institution of health care of the city of Moscow "diagnostic centre № 5 associated with policlinic department of Moscow Healthcare Department"
Moscow, , Russia
State budgetary institution of health care of the city of Moscow "diagnostic clinical centre № 1 Moscow Healthcare Department "
Moscow, , Russia
State budgetary institution of health care of the city of Moscow "Municipal Polyclinic № 2 Moscow Healthcare Department"
Moscow, , Russia
State budgetary institution of health care of the city of Moscow "Municipal Polyclinic № 36 Moscow Healthcare Department"
Moscow, , Russia
State budgetary institution of health care of the city of Moscow "Municipal Polyclinic № 6 Moscow Healthcare Department"
Moscow, , Russia
State budgetary institution of health care of the city of Moscow "Municipal Polyclinic № 62 Moscow Healthcare Department"
Moscow, , Russia
State budgetary institution of health care of the city of Moscow "Municipal Polyclinic № 64 Moscow Healthcare Department"
Moscow, , Russia
St. Petersburg's state budgetary health care Institution "Municipal hospital № 40 of Kurortniy area"
Saint Petersburg, , Russia
St. Petersburg's state budgetary health care Institution "Municipal hospital №117"
Saint Petersburg, , Russia
Federal state budgetary educational Institution for Higher Education "Saratov State Medical University named after V.I. Razumovskiy" Ministry of Health of Russian Federation
Saratov, , Russia
LLC "Uromed"
Smolensk, , Russia
Countries
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Central Contacts
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Facility Contacts
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Vladimir Rafalskiy
Role: primary
Elena Klimova, MD
Role: primary
Anna Gratzianskaya
Role: primary
Natalia Nenasheva, MD
Role: primary
Tamara Vilegzhanina
Role: primary
Natalia Shartanova
Role: primary
Sergey Fitilev, MD
Role: primary
Irina Isakova
Role: primary
Marina Ivzhits
Role: primary
Marina Rusanova, MD, PhD
Role: primary
Svetlana Rachina
Role: primary
Alina Agafina, MD
Role: primary
Diana Alpenidze
Role: primary
Yury Shvarts
Role: primary
Alla Andreeva
Role: primary
Other Identifiers
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01 - Sputnik Light - 2021
Identifier Type: -
Identifier Source: org_study_id
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