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Trial record 2 of 2 for:    sputnik light | covid-19

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04713488
Recruitment Status : Active, not recruiting
First Posted : January 19, 2021
Last Update Posted : February 2, 2021
Sponsor:
Collaborator:
Russian Direct Investment Fund
Information provided by (Responsible Party):
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

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

Condition or disease Intervention/treatment Phase
COVID-19 Prevention Biological: Sputnik Light Phase 1 Phase 2

Detailed Description:

Screening Period = up to 7 days All screening procedures must be executed within the shortest possible time frame before the scheduled date for Visit 1 (drug administration). The laboratory and instrumental examination data obtained within 14 days before the screening will be recorded as the screening data.

The trial will include 110 volunteers that will be administered the study drug. Outpatient observation will be done over the course of 4 visits: on day 10, 28, and 42 following drug administration Along with that, the study will be continued in accordance with the Protocol, accompanied by all the prescribed procedures and visits up to 180 days of observation.

Visit No. 0 (outpatient): screening Visit No. 1 (outpatient): vaccination Visits No. 2, 3, 4, 5, and 8: follow-up on days 10, 28, 42, 90, and180 after vaccination.

On days 120 and 150, visits 6 and 7 will be accomplished by telephone contact / telemedicine conference or, if necessary, in the form of an in-person visit.

Any volunteer who received a dose of the study drug will be registered as a trial participant, and his/her data will be used to help assess the drug's safety and tolerability.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Open Study on the Safety, Tolerability, and Immunogenicity of "Sputnik Light" t Vaccine for Prevention of Coronavirus Infection Caused by the SARS-CoV-2 Viruso
Actual Study Start Date : January 15, 2021
Estimated Primary Completion Date : July 20, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sputnik Light Vaccine
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
solution for intramuscular injection Composition for 1 dose (0.5 ml)
Other Name: vector vaccine to help prevent the SARS-CoV-2-induced coronavirus infection




Primary Outcome Measures :
  1. Changing of antibody levels against the SARS-CoV-2 glycoprotein S [ Time Frame: at days 0,10, 28, 42, 180 ]
    Determination of antibody levels against the SARS-CoV-2 glycoprotein S measured by an ELISA vs. baseline values

  2. Number of Participants With Adverse Events [ Time Frame: through the whole study, an average of 180 days ]
    Determination of Number of Participants With Adverse Events


Secondary Outcome Measures :
  1. Changing of of virus neutralizing antibody titer [ Time Frame: at days 0, 28, 42 ]
    Determination of changing of virus neutralizing antibody titer from baseline scores and at day 28 and 42

  2. Changing of antigen-specific cellular immunity level [ Time Frame: at days 0, 10 ]
    Determination of antigen-specific cellular immunity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 111 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Written informed consent given by the subject to participate in the trial;
  2. Males and females aged 18 years old and older
  3. 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)
  4. Negative COVID-2019 PCR test result during the screening visit
  5. No contact with COVID-2019-infected persons within at least 14 days before being included in the trial (according to what trial subjects state);
  6. Negative HIV and hepatitis test results;
  7. Consent to use effective contraception methods during the trial
  8. Negative drugs or psychostimulants urine test during the screening visit;
  9. Negative alcohol test during the screening visit;
  10. Negative test for pregnancy (done for women with preserved reproductive potential)
  11. No evident vaccine-induced reactions or complications after receiving immunobiological products in the person's medical history;
  12. No acute infectious and/or respiratory diseases within at least 14 days before being included in the trial

Exclusion Criteria:

  1. 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;
  2. Steroid therapy (except hormonal contraceptives or drugs used as hormone replacement therapy for menopause) that has not been completed 30 days before enrollment;
  3. Therapy with immunoglobulins or other blood products not completed 30 days before enrollment in the trial
  4. Immunosuppressor therapy that was completed within 3 months before being included in the trial
  5. A vaccination against COVID-2019 using any other drugs, including in the course of other clinical studies
  6. Female subjects during pregnancy or breastfeeding (for women with preserved reproductive potential);
  7. Acute coronary syndrome or stroke suffered less than one year before enrolling in the trial
  8. Tuberculosis, chronic systemic infections;
  9. 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;
  10. Neoplasms in a person's medical history (ICD codes C00-D09);
  11. Donated blood or plasma (450+ ml) within 2 months before enrollment;
  12. Splenectomy in the person's medical history;
  13. 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;
  14. Active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis B or C;
  15. Anorexia, protein deficiency of any origin;
  16. Large tattoos at the injection site (deltoid muscle area), which does not allow assessing the localized response to administering the study drug/placebo
  17. Alcohol or drug addiction in the person's medical history;
  18. Registered with a psychiatrist
  19. Participation in any other interventional clinical Trial within 90 days before the start of this trial
  20. Any other condition that the researching physician considers to be a hindrance to completing the trial as per the protocol;
  21. Research facility staff and other employees directly involved in the trial (research team members) and their families.
  22. Any related conditions that, in the opinion of the study physician, could serve as a hindrance to participating in the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04713488


Locations
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Russian Federation
ECO-Safety
Sankt Peterburg, Russian Federation
Sponsors and Collaborators
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Russian Direct Investment Fund
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Responsible Party: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
ClinicalTrials.gov Identifier: NCT04713488    
Other Study ID Numbers: 06 - Sputnik Light - 2020
First Posted: January 19, 2021    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation:
COVID-19
vaccine
vector vaccine
Immunologic Factors
SARS-CoV-2
Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs