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| Name | Class |
|---|---|
| Russian Direct Investment Fund | INDUSTRY |
| CRO: iPharma | UNKNOWN |
| Government of the city of Moscow | UNKNOWN |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sputnik Light Vaccine | Active Comparator | study group (4500 receiving the Sputnik-Light vector vaccine) against the SARS-СoV-2-induced coronavirus infection. |
|
| Placebo Group | Placebo Comparator | control group (1500 subjects receiving placebo) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sputnik Light | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events in study subjects | Incidence and severity of AEs and SAEs during the subject's participation in the study | 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 | through the whole study, an average of 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Humoral immunogenicity (Quantitative IgG antibodies to SARS-CoV-2 S Protein) | Geometric mean titer (GMT) levels of Quantitative IgG antibodies | at days 0, 42, 180 |
| Humoral immunogenicity (IgG SARS-CoV-2 N-antibodies) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elena Merkulova | Contact | +7 (495) 276 11 43 | 495 | eam@ipharma.ru |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal State Autonomous Educational Institution for Higher Education "Immanuel Kant Baltic Federal University" | Not yet recruiting | Kaliningrad | Russia |
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randomized, double-blind (blinded for the study subject and investigators), placebo-controlled
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| Placebo | Other | Placebo |
|
Percentage of study subjects who have a post-treatment response as measures with Qualitative IgG SARS-CoV-2 N-antibodies
| at days 0, 42, 180 |
| State Budgetary Healthcare Institution, Moscow, Consultation and Diagnosis Polyclinic No. 121, Moscow Healthcare Department | Recruiting | Moscow | Russia |
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| State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 210, Moscow Healthcare Department | Recruiting | Moscow | Russia |
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| State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 219, Moscow Healthcare Department | Recruiting | Moscow | Russia |
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| State budgetary institution of health care of the city of Moscow "diagnostic centre № 5 associated with policlinic department of Moscow Healthcare Department" | Not yet recruiting | Moscow | Russia |
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| State budgetary institution of health care of the city of Moscow "diagnostic clinical centre № 1 Moscow Healthcare Department " | Recruiting | Moscow | Russia |
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| State budgetary institution of health care of the city of Moscow "Municipal Polyclinic № 2 Moscow Healthcare Department" | Recruiting | Moscow | Russia |
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| State budgetary institution of health care of the city of Moscow "Municipal Polyclinic № 36 Moscow Healthcare Department" | Recruiting | Moscow | Russia |
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| State budgetary institution of health care of the city of Moscow "Municipal Polyclinic № 6 Moscow Healthcare Department" | Not yet recruiting | Moscow | Russia |
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| State budgetary institution of health care of the city of Moscow "Municipal Polyclinic № 62 Moscow Healthcare Department" | Recruiting | Moscow | Russia |
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| State budgetary institution of health care of the city of Moscow "Municipal Polyclinic № 64 Moscow Healthcare Department" | Recruiting | Moscow | Russia |
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| St. Petersburg's state budgetary health care Institution "Municipal hospital № 40 of Kurortniy area" | Not yet recruiting | Saint Petersburg | Russia |
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| St. Petersburg's state budgetary health care Institution "Municipal hospital №117" | Not yet recruiting | Saint Petersburg | Russia |
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| Federal state budgetary educational Institution for Higher Education "Saratov State Medical University named after V.I. Razumovskiy" Ministry of Health of Russian Federation | Not yet recruiting | Saratov | Russia |
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| LLC "Uromed" | Not yet recruiting | Smolensk | Russia |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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