An Open Study on the Safety, Tolerability, and Immunogenicity of "Sputnik Light" Vaccine

NCT04713488 | Unknown Phase 1

• 1 other identifier: 06 - Sputnik Light - 2020
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Phase I-II open prospective, two-stage, non-randomized study in healthy volunteers.

Conditions

COVID-19 Prevention

Keywords

COVID-19; vaccine; vector vaccine; Immunologic Factors; SARS-CoV-2

Outcome Measures

Primary Outcomes (2)

• Changing of antibody levels against the SARS-CoV-2 glycoprotein S

  Determination of antibody levels against the SARS-CoV-2 glycoprotein S measured by an ELISA vs. baseline values

  at days 0,10, 28, 42, 180

• Number of Participants With Adverse Events

  Determination of Number of Participants With Adverse Events

  through the whole study, an average of 180 days

Secondary Outcomes (2)

• Changing of of virus neutralizing antibody titer

  at days 0, 28, 42

• Changing of antigen-specific cellular immunity level

  at days 0, 10

Study Arms (1)

Sputnik Light Vaccine

EXPERIMENTAL

solution for intramuscular injection Composition for 1 dose (0.5 ml): Active substance: recombinant serotype 26 adenoviral particles containing the SARS-CoV-2 S protein gene, in the amount of (1.0±0.5) x 10\*11 particles per dose.

Biological: Sputnik Light

Interventions

Sputnik Light BIOLOGICAL

solution for intramuscular injection Composition for 1 dose (0.5 ml)

Also known as: vector vaccine to help prevent the SARS-CoV-2-induced coronavirus infection

Sputnik Light Vaccine

Eligibility Criteria

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

You may qualify if:

• Written informed consent given by the subject to participate in the trial;
• Males and females aged 18 years old and older
• Lack of COVID-2019 in medical history: negative IgM and IgG SARS CoV2 antibodies enzyme-linked immunosorbent assay test result (no more than 14 days before being included in the trial)
• Negative COVID-2019 PCR test result during the screening visit
• No contact with COVID-2019-infected persons within at least 14 days before being included in the trial (according to what trial subjects state);
• Negative HIV and hepatitis test results;
• Consent to use effective contraception methods during the trial
• Negative drugs or psychostimulants urine test during the screening visit;
• Negative alcohol test during the screening visit;
• Negative test for pregnancy (done for women with preserved reproductive potential)
• No evident vaccine-induced reactions or complications after receiving immunobiological products in the person's medical history;
• No acute infectious and/or respiratory diseases within at least 14 days before being included in the trial

You may not qualify if:

• Any vaccination / immunization performed within 14 days prior to enrollment in the study, or a planned vaccination within 14 days after being administered the study drug;
• Steroid therapy (except hormonal contraceptives or drugs used as hormone replacement therapy for menopause) that has not been completed 30 days before enrollment;
• Therapy with immunoglobulins or other blood products not completed 30 days before enrollment in the trial
• Immunosuppressor therapy that was completed within 3 months before being included in the trial
• A vaccination against COVID-2019 using any other drugs, including in the course of other clinical studies
• Female subjects during pregnancy or breastfeeding (for women with preserved reproductive potential);
• Acute coronary syndrome or stroke suffered less than one year before enrolling in the trial
• Tuberculosis, chronic systemic infections;
• Complicated allergic history (severe life-threatening allergic reactions), hypersensitivity or allergic reactions to the introduction of immunobiological drugs, known allergic reactions to the components of the drug, exacerbation of allergic diseases on the day of enrolling in the trial;
• Neoplasms in a person's medical history (ICD codes C00-D09);
• Donated blood or plasma (450+ ml) within 2 months before enrollment;
• Splenectomy in the person's medical history;
• Neutropenia (absolute neutrophil count \<1,000 mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin \<80 g/L), immunodeficiency in the medical history within 6 months before the enrollment;
• Active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis B or C;
• Anorexia, protein deficiency of any origin;

Sponsors & Collaborators

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

Study Sites (1)

ECO-Safety

Saint Petersburg, Russia

Location

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 19, 2021
• Study Start: January 15, 2021
• Primary Completion: July 20, 2021
• Study Completion: July 31, 2021
• Last Updated: February 2, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)