Study to Evaluate Efficacy, Immunogenicity and Safety of the Sputnik-Light (SPUTNIK-LIGHT)

• ClinicalTrials.gov Identifier: NCT04741061
• Recruitment Status: Unknown
• First Posted: February 5, 2021
• Last Update Posted: February 21, 2021
• Sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
• Collaborators: Russian Direct Investment Fund; CRO: iPharma; Government of the city of Moscow
• Information provided by (Responsible Party): Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Tracking Information

• First Submitted Date: February 2, 2021
• First Posted Date: February 5, 2021
• Last Update Posted Date: February 21, 2021
• Actual Study Start Date: February 19, 2021
• Estimated Primary Completion Date: December 31, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 4, 2021)

• 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 4, 2021)

• Humoral immunogenicity (Quantitative IgG antibodies to SARS-CoV-2 S Protein) [ Time Frame: at days 0, 42, 180 ]
  Geometric mean titer (GMT) levels of Quantitative IgG antibodies
• Humoral immunogenicity (IgG SARS-CoV-2 N-antibodies) [ Time Frame: at days 0, 42, 180 ]
  Percentage of study subjects who have a post-treatment response as measures with Qualitative IgG SARS-CoV-2 N-antibodies

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study to Evaluate Efficacy, Immunogenicity and Safety of the Sputnik-Light
• 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
• Brief 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. 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 Type: Interventional
• Study Phase: Phase 3

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

randomized, double-blind (blinded for the study subject and investigators), placebo-controlled

Masking: Double (Participant, Investigator)
Primary Purpose: Prevention

• Condition: COVID-19 Prevention

Intervention

• Biological: 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.

• Other: Placebo
  Placebo

Study Arms

• Active Comparator: Sputnik Light Vaccine
  study group (4500 receiving the Sputnik-Light vector vaccine) against the SARS-СoV-2-induced coronavirus infection.
  Intervention: Biological: Sputnik Light
• Placebo Comparator: Placebo Group
  control group (1500 subjects receiving placebo)
  Intervention: Other: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 4, 2021): 6000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 31, 2022
• Estimated Primary Completion Date: December 31, 2021 (Final data collection date for primary outcome measure)

Eligibility 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. 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:

1. Any previous vaccination/immunization (within 30 days before the enrollment) and any planned vaccination within 30 days after enrollment
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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 111 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Russian Federation

Administrative Information

• NCT Number: NCT04741061
• Other Study ID Numbers: 01 - Sputnik Light - 2021
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
• Original Responsible Party: Same as current
• Current Study Sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
• Original Study Sponsor: Same as current

Collaborators

• Russian Direct Investment Fund
• CRO: iPharma
• Government of the city of Moscow

• Investigators: Not Provided
• PRS Account: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
• Verification Date: February 2021