COVID 19 /SARS-CoV-2 Infection Prophylactic Treatment
Conditions
Interventions
Sputnik Light Vector Vaccine
Placebo
Sponsors
Limited Liability Company Human Vaccine part of the group of the entities of JointStock Company Management Company of Russian Direct Investment Fund
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Agree to sign the study informed consent form (ICF) before performing any study-specific procedure. 2. Adults = 18 years old 3. Absence of COVID-19 that is confirmed with negative immunochromatographic SARS-CoV-2 antigen rapid test at randomization test use of point of care test system at the screening visit 4. Consent for using effective methods of contraception during the entire trial and 3 months after its completion 5. No evidence of pronounced 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 enrollment.
Exclusion criteria
Exclusion criteria: Inclusion criteria: 1. Agree to sign the study informed consent form (ICF) before performing any study-specific procedure. 2. Adults = 18 years old 3. Absence of COVID-19 that is confirmed with negative immunochromatographic SARS-CoV-2 antigen rapid test at randomization test use of point of care test system at the screening visit 4. Consent for using effective methods of contraception during the entire trial and 3 months after its completion 5. No evidence of pronounced 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 enrollment. Exclusion criteria: 1. Any previous vaccination/immunization (except for COVID-19 vaccination) within 30 days before the enrollment and any planned vaccination within 30 days after enrollment. 2. Any previous COVID-19 vaccination or planned vaccination against COVID-19 with another vaccine approved by the regulatory authority 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 breast-feeding 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 immune disease or systemic collagenosis in medical history 10. Subjects who received transplantation and on immunosuppressive therapy 11. Other immunosuppressive therapy that completed less than three months prior to randomization into the study 12. Splenectomy in the past medical history 13. Subjects with oncological disease within 5 years prior to inclusion into the study 14. Neutropenia (absolute neutrophil count less than <1000/mm2), agranulocytosis, significant loss of blood, severe anemia (hemoglobin < 80 g/l) Immunodeficiency in the medical history within 6 months before the enrollment 15. 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 Malnutrition 18. Tattoos or scars at the injection site (deltoid muscle area), which in the medical opinion of the investigator does not allow assessing the local response to the study vaccine/placebo administration 19. Alcohol or Drug addiction 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 study physician considers as a barrier to the trial completion as per the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoints: 1.Proportion of study subjects with active COVID-19 disease developed 21±2 days after vaccination with the Sputnik-Light vector vaccine as compared with placebo 2.Incidence and severity of adverse events in trial subjects: a.Incidence of local and systemic reactions to the vaccine in 7 days after injection with vaccine/placebo b.Incidence and severity of AEs and SAEs over the course of subject’s participation in the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints: 1. Humoral immunogenicity induced by the vaccine resulting in increase in the Quantitative IgG antibodies to SARS-CoV-2 S Protein in trial subjects (Subset A, 1 076 Subjects) a. Geometric mean titer (GMT) levels of Quantitative IgG antibodies to S Protein from baseline levels at Visit 1 (vaccination day, prior to injecting the first dose of the study vaccine/placebo) to Visit 2 (Day 42) and Visit 3 (Day 180) after injection with vaccine/placebo b. Percentage of trial subjects with four-fold or more increase in the titers of Quantitative IgG antibodies to S Protein from baseline levels at Visit 1 (vaccination day, prior to injecting the first dose of the study vaccine/placebo) to Visit 2 (Day 42) and Visit 3 (Day 180) after injection with vaccine/placebo c. Percentage of trial subjects with seroconversion to SARS-CoV-2 S Protein from baseline levels at Visit 1 (vaccination day, prior to injecting the first dose of the study vaccine/placebo) to Visit 2 (Day 42) and Visit 3 (Day 180) after injection with vaccine/placebo d. Immunogenicity of the Sputnik-Light vector vaccine against the SARS-CoV-2-induced coronavirus infection compared to placebo for the levels of virus-neutralizing antibodies compared at baseline (Visit 1), to Visit 2 (Day 42) and Visit 3 (Day 180) after injection with vaccine/placebo 2. Percentage of trial subjects who have a post-treatment response as measures with Qualitative IgG and IgM SARS-CoV-2 N-antibodies at to Visit 2 (Day 42) and Visit 3 (Day 180) after injection with vaccine/placebo 3. Percentage of trial subjects with severe and extremely severe COVID-19 disease that developed after vaccination with Sputnik Light compared to placebo | — |
Countries
Ghana
Contacts
Public ContactAlberta Amu
Clinical Epidemiologist
Outcome results
None listed