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

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

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.

Study Overview

• Status: Unknown
• Conditions: COVID-19 Prevention
• Intervention / Treatment: Other: Placebo; Biological: Sputnik Light

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
• Enrollment (Anticipated): 6000
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Elena Merkulova; Phone Number: 495 +7 (495) 276 11 43; Email: eam@ipharma.ru

Study Locations

• Russian Federation
  • Kaliningrad, Russian Federation
    • Not yet recruiting
    • Federal State Autonomous Educational Institution for Higher Education "Immanuel Kant Baltic Federal University"
    • Contact: Vladimir Rafalskiy
    • Principal Investigator: Vladimir Rafalskiy
  • Moscow, Russian Federation
    • Recruiting
    • State Budgetary Healthcare Institution, Moscow, Consultation and Diagnosis Polyclinic No. 121, Moscow Healthcare Department
    • Contact: Elena Klimova, MD
  • Moscow, Russian Federation
    • Recruiting
    • State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 210, Moscow Healthcare Department
    • Contact: Anna Gratzianskaya
  • Moscow, Russian Federation
    • Recruiting
    • State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 219, Moscow Healthcare Department
    • Contact: Natalia Nenasheva, MD
  • Moscow, Russian Federation
    • Not yet recruiting
    • State budgetary institution of health care of the city of Moscow "diagnostic centre № 5 associated with policlinic department of Moscow Healthcare Department"
    • Contact: Tamara Vilegzhanina
    • Principal Investigator: Tamara Vilegzhanina
  • Moscow, Russian Federation
    • Recruiting
    • State budgetary institution of health care of the city of Moscow "diagnostic clinical centre № 1 Moscow Healthcare Department "
    • Contact: Natalia Shartanova
    • Principal Investigator: Natalia Shartanova
  • Moscow, Russian Federation
    • Recruiting
    • State budgetary institution of health care of the city of Moscow "Municipal Polyclinic № 2 Moscow Healthcare Department"
    • Contact: Sergey Fitilev, MD
    • Principal Investigator: Sergey Fitilev
  • Moscow, Russian Federation
    • Recruiting
    • State budgetary institution of health care of the city of Moscow "Municipal Polyclinic № 36 Moscow Healthcare Department"
    • Contact: Irina Isakova
    • Principal Investigator: Irina Isakova
  • Moscow, Russian Federation
    • Not yet recruiting
    • State budgetary institution of health care of the city of Moscow "Municipal Polyclinic № 6 Moscow Healthcare Department"
    • Contact: Marina Ivzhits
    • Principal Investigator: Marina Ivzhits
  • Moscow, Russian Federation
    • Recruiting
    • State budgetary institution of health care of the city of Moscow "Municipal Polyclinic № 62 Moscow Healthcare Department"
    • Contact: Marina Rusanova, MD, PhD
    • Principal Investigator: Marina Rusanova
  • Moscow, Russian Federation
    • Recruiting
    • State budgetary institution of health care of the city of Moscow "Municipal Polyclinic № 64 Moscow Healthcare Department"
    • Contact: Svetlana Rachina
    • Principal Investigator: Svetlana Rachina
  • Saint Petersburg, Russian Federation
    • Not yet recruiting
    • St. Petersburg's state budgetary health care Institution "Municipal hospital № 40 of Kurortniy area"
    • Contact: Alina Agafina, MD
    • Principal Investigator: Alina Agafina
  • Saint Petersburg, Russian Federation
    • Not yet recruiting
    • St. Petersburg's state budgetary health care Institution "Municipal hospital №117"
    • Contact: Diana Alpenidze
    • Principal Investigator: Diana Alpenidze
  • Saratov, Russian Federation
    • Not yet recruiting
    • Federal state budgetary educational Institution for Higher Education "Saratov State Medical University named after V.I. Razumovskiy" Ministry of Health of Russian Federation
    • Contact: Yury Shvarts
    • Principal Investigator: Yury Shvarts
  • Smolensk, Russian Federation
    • Not yet recruiting
    • LLC "Uromed"
    • Contact: Alla Andreeva
    • Principal Investigator: Alla Andreeva

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 111 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Sputnik Light Vaccine; study group (4500 receiving the Sputnik-Light vector vaccine) against the SARS-СoV-2-induced coronavirus infection.	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.
PLACEBO_COMPARATOR: Placebo Group; control group (1500 subjects receiving placebo)	Other: Placebo; Placebo

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
• Collaborators: Government of the city of Moscow; Russian Direct Investment Fund; CRO: iPharma

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 19, 2021
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): January 31, 2022

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (ACTUAL): February 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 19, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: SARS-CoV-2; vaccine; COVID-19; vector vaccine; adenovirus vector
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 01 - Sputnik Light - 2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No