Study to Evaluate Efficacy, Immunogenicity and Safety of the Sputnik-Light

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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

Conditions
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COVID-19 Prevention

Intervention / Treatment
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* Biological: Sputnik Light
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 111 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized, double-blind (blinded for the study subject and investigators), placebo-controlled
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sputnik Light Vaccine<br>study group (4500 receiving the Sputnik-Light vector vaccine) against the SARS-СoV-2-induced coronavirus infection. | Biological: Sputnik Light<br>* 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.<br>|
| Placebo Comparator: Placebo Group<br>control group (1500 subjects receiving placebo) | Other: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, vaccine, vector vaccine, adenovirus vector, SARS-CoV-2