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Study of "Sputnik Lite" for the Prevention of COVID-19 With Altered Antigenic Composition.

Primary Purpose

COVID-19

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
"Sputnik Lite" vaccine for the prevention of COVID-19 with altered antigenic composition
Sponsored by
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: The study will include volunteers who meet all the specified criteria: Subject's written informed consent to participate in the study; Adult volunteer's men and women over 18 years old; A negative test result for COVID-19, determined by PCR or express method before the introduction of the investigational medicinal product (IMP). Consent to the use of effective methods of contraception during the entire period of participation in the study; A negative pregnancy test based on the results of a urine test at a screening visit (for women with preserved reproductive potential); Negative test for the presence of narcotic and psychostimulants in the urine at the screening visit; Negative alcohol content test at the screening visit; No contraindications to vaccination; Absence of acute infectious and/or respiratory diseases for at least 14 days prior to inclusion in the study. Exclusion Criteria: Volunteers cannot be included in the study if there is at least one of the following criteria for non-inclusion: No signed informed consent to participate in the study; Therapy with steroids (with the exception of hormonal contraceptives and/or hormone replacement therapy) and / or immunoglobulins or other blood products that did not end 30 days before inclusion in the study; Therapy with any immunosuppressive drugs completed less than 3 months before inclusion in the study; Female subjects during pregnancy or lactation; Acute coronary syndrome or stroke suffered less than one year before inclusion in the study; Tuberculosis, chronic systemic infections according to anamnesis; Burdened allergic anamnesis (the presence in the anamnesis of information about anaphylactic shock, Quincke's edema, polymorphic exudative eczema, serum sickness), hypersensitivity or allergic reactions to the administration of immunobiological drugs, known allergic reactions to the components of the drug, exacerbation of allergic diseases on the day of inclusion in the study; The presence of neoplasms (ICD codes C00-D09) (according to the anamnesis); Splenectomy (according to the anamnesis); Neutropenia (decrease in the absolute number of neutrophils less than 1000/mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin less than 80 g/l), immunodeficiency - 6 months prior to inclusion in the study (according to the anamnesis); Subjects with an active form of the disease caused by human immunodeficiency virus, syphilis, hepatitis B and C (according to anamnesis); Anorexia, protein deficiency of any origin; Alcoholism and drug addiction (according to anamnesis); The subject's participation in any other interventional clinical trial (with the exception of rescreening in the current study) in the last 90 days; Extensive tattoos at the injection sites (deltoid muscle area), which do not allow to assess the local reaction to the introduction of investigational medicinal product (IMP); Any other condition of the subject of the study, which, in the opinion of the research doctor, may prevent the completion of the study in accordance with the protocol; Vaccination against COVID-19 or transmitted coronavirus infection COVID-19 less than 6 months before screening; Repeated administration of the Sputnik V vaccine, Sputnik Lite, or repeated administration of any other COVID-19 vaccine for more than three injections (Sputnik V vaccination plus Sputnik Lite revaccination); Inability to read in Russian; inability or unwillingness to understand the essence of the study; Any other conditions that limit the validity of obtaining informed consent or may affect the ability of the volunteer to participate in the study, affect the ability of the volunteer to participate in the study; Staff of research centers (chief researcher and members of the research team) directly involved in the research and their family members.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Healthy patients

    Arm Description

    Drug: Sputnik Light vector vaccine for the prevention of coronavirus infection caused by the SARS CoV-2 virus (with altered antigenic composition); A total of 50 people will be randomized and receive the study drug. A single intramuscular injection of the investigational medicinal product (IMP) will be performed.

    Outcomes

    Primary Outcome Measures

    Occurrence of adverse events (AE)
    Occurrence of adverse events (AE)
    Occurrence of serious adverse events (SAEs)
    Occurrence of serious adverse events (SAEs)

    Secondary Outcome Measures

    Full Information

    First Posted
    September 21, 2023
    Last Updated
    September 26, 2023
    Sponsor
    Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06057025
    Brief Title
    Study of "Sputnik Lite" for the Prevention of COVID-19 With Altered Antigenic Composition.
    Official Title
    Safety, Reactogenicity and Immunogenicity Study of the Drug "Sputnik Lite" for the Prevention of Coronavirus (COVID-19) Infection Caused by the SARS-CoV-2 Virus With Altered Antigenic Composition With Participation of Adult Volunteers.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

    4. Oversight

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

    5. Study Description

    Brief Summary
    Safety, reactogenicity and immunogenicity study of the drug "Sputnik Lite" for the prevention of coronavirus infection caused by the SARS-CoV-2 virus with altered antigenic composition with participation of adult volunteers.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COVID-19

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Healthy patients
    Arm Type
    Experimental
    Arm Description
    Drug: Sputnik Light vector vaccine for the prevention of coronavirus infection caused by the SARS CoV-2 virus (with altered antigenic composition); A total of 50 people will be randomized and receive the study drug. A single intramuscular injection of the investigational medicinal product (IMP) will be performed.
    Intervention Type
    Biological
    Intervention Name(s)
    "Sputnik Lite" vaccine for the prevention of COVID-19 with altered antigenic composition
    Intervention Description
    Single intramuscular injection of "Sputnik Lite" vaccine for the prevention of COVID-19 with altered antigenic composition.
    Primary Outcome Measure Information:
    Title
    Occurrence of adverse events (AE)
    Description
    Occurrence of adverse events (AE)
    Time Frame
    Within 28 days after administration of the drug
    Title
    Occurrence of serious adverse events (SAEs)
    Description
    Occurrence of serious adverse events (SAEs)
    Time Frame
    Throughout Study completion, until December 2024

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: The study will include volunteers who meet all the specified criteria: Subject's written informed consent to participate in the study; Adult volunteer's men and women over 18 years old; A negative test result for COVID-19, determined by PCR or express method before the introduction of the investigational medicinal product (IMP). Consent to the use of effective methods of contraception during the entire period of participation in the study; A negative pregnancy test based on the results of a urine test at a screening visit (for women with preserved reproductive potential); Negative test for the presence of narcotic and psychostimulants in the urine at the screening visit; Negative alcohol content test at the screening visit; No contraindications to vaccination; Absence of acute infectious and/or respiratory diseases for at least 14 days prior to inclusion in the study. Exclusion Criteria: Volunteers cannot be included in the study if there is at least one of the following criteria for non-inclusion: No signed informed consent to participate in the study; Therapy with steroids (with the exception of hormonal contraceptives and/or hormone replacement therapy) and / or immunoglobulins or other blood products that did not end 30 days before inclusion in the study; Therapy with any immunosuppressive drugs completed less than 3 months before inclusion in the study; Female subjects during pregnancy or lactation; Acute coronary syndrome or stroke suffered less than one year before inclusion in the study; Tuberculosis, chronic systemic infections according to anamnesis; Burdened allergic anamnesis (the presence in the anamnesis of information about anaphylactic shock, Quincke's edema, polymorphic exudative eczema, serum sickness), hypersensitivity or allergic reactions to the administration of immunobiological drugs, known allergic reactions to the components of the drug, exacerbation of allergic diseases on the day of inclusion in the study; The presence of neoplasms (ICD codes C00-D09) (according to the anamnesis); Splenectomy (according to the anamnesis); Neutropenia (decrease in the absolute number of neutrophils less than 1000/mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin less than 80 g/l), immunodeficiency - 6 months prior to inclusion in the study (according to the anamnesis); Subjects with an active form of the disease caused by human immunodeficiency virus, syphilis, hepatitis B and C (according to anamnesis); Anorexia, protein deficiency of any origin; Alcoholism and drug addiction (according to anamnesis); The subject's participation in any other interventional clinical trial (with the exception of rescreening in the current study) in the last 90 days; Extensive tattoos at the injection sites (deltoid muscle area), which do not allow to assess the local reaction to the introduction of investigational medicinal product (IMP); Any other condition of the subject of the study, which, in the opinion of the research doctor, may prevent the completion of the study in accordance with the protocol; Vaccination against COVID-19 or transmitted coronavirus infection COVID-19 less than 6 months before screening; Repeated administration of the Sputnik V vaccine, Sputnik Lite, or repeated administration of any other COVID-19 vaccine for more than three injections (Sputnik V vaccination plus Sputnik Lite revaccination); Inability to read in Russian; inability or unwillingness to understand the essence of the study; Any other conditions that limit the validity of obtaining informed consent or may affect the ability of the volunteer to participate in the study, affect the ability of the volunteer to participate in the study; Staff of research centers (chief researcher and members of the research team) directly involved in the research and their family members.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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