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

NCT04741061 | Unknown Phase 3

• 1 other identifier: 01 - Sputnik Light - 2021
• Study Type: interventional
• Target: 6,000
• Locations: 1 country
• Sites: 15

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.

Conditions

COVID-19 Prevention

Keywords

COVID-19; vaccine; vector vaccine; adenovirus vector; SARS-CoV-2

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Humoral immunogenicity (Quantitative IgG antibodies to SARS-CoV-2 S Protein)

  at days 0, 42, 180

• Humoral immunogenicity (IgG SARS-CoV-2 N-antibodies)

  at days 0, 42, 180

Study Arms (2)

Sputnik Light Vaccine

ACTIVE COMPARATOR

study group (4500 receiving the Sputnik-Light vector vaccine) against the SARS-СoV-2-induced coronavirus infection.

Biological: Sputnik Light

Placebo Group

PLACEBO COMPARATOR

control group (1500 subjects receiving placebo)

Other: Placebo

Interventions

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.

Sputnik Light Vaccine

Placebo OTHER

Placebo

Placebo Group

Eligibility Criteria

• Age: 18 Years - 111 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (15)

Federal State Autonomous Educational Institution for Higher Education "Immanuel Kant Baltic Federal University"

Kaliningrad, Russia

NOT YET RECRUITING

State Budgetary Healthcare Institution, Moscow, Consultation and Diagnosis Polyclinic No. 121, Moscow Healthcare Department

Moscow, Russia

RECRUITING

State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 210, Moscow Healthcare Department

Moscow, Russia

RECRUITING

State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 219, Moscow Healthcare Department

Moscow, Russia

RECRUITING

State budgetary institution of health care of the city of Moscow "diagnostic centre № 5 associated with policlinic department of Moscow Healthcare Department"

Moscow, Russia

NOT YET RECRUITING

State budgetary institution of health care of the city of Moscow "diagnostic clinical centre № 1 Moscow Healthcare Department "

Moscow, Russia

RECRUITING

State budgetary institution of health care of the city of Moscow "Municipal Polyclinic № 2 Moscow Healthcare Department"

Moscow, Russia

RECRUITING

State budgetary institution of health care of the city of Moscow "Municipal Polyclinic № 36 Moscow Healthcare Department"

Moscow, Russia

RECRUITING

State budgetary institution of health care of the city of Moscow "Municipal Polyclinic № 6 Moscow Healthcare Department"

Moscow, Russia

NOT YET RECRUITING

State budgetary institution of health care of the city of Moscow "Municipal Polyclinic № 62 Moscow Healthcare Department"

Moscow, Russia

RECRUITING

State budgetary institution of health care of the city of Moscow "Municipal Polyclinic № 64 Moscow Healthcare Department"

Moscow, Russia

RECRUITING

St. Petersburg's state budgetary health care Institution "Municipal hospital № 40 of Kurortniy area"

Saint Petersburg, Russia

NOT YET RECRUITING

St. Petersburg's state budgetary health care Institution "Municipal hospital №117"

Saint Petersburg, Russia

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

Saratov, Russia

NOT YET RECRUITING

LLC "Uromed"

Smolensk, Russia

NOT YET RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Elena Merkulova

CONTACT

+7 (495) 276 11 43; eam@ipharma.ru

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 5, 2021
• Study Start: February 19, 2021
• Primary Completion: December 31, 2021
• Study Completion: January 31, 2022
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (15)