Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE January 13, 2021
First Posted Date  ICMJE January 19, 2021
Last Update Posted Date February 2, 2021
Actual Study Start Date  ICMJE January 15, 2021
Estimated Primary Completion Date July 20, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2021)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2021)
  • 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
  • Changing of antigen-specific cellular immunity level [ Time Frame: at days 0, 10 ]
    Determination of antigen-specific cellular immunity
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open Study on the Safety, Tolerability, and Immunogenicity of "Sputnik Light" Vaccine
Official Title  ICMJE 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
Brief Summary Phase I-II open prospective, two-stage, non-randomized study in healthy volunteers.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE COVID-19 Prevention
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Biological: Sputnik Light
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 15, 2021)
110
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2021
Estimated Primary Completion Date July 20, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 111 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04713488
Other Study ID Numbers  ICMJE 06 - Sputnik Light - 2020
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Russian Direct Investment Fund
Investigators  ICMJE Not Provided
PRS Account Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP