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

• ClinicalTrials.gov Identifier: NCT04713488
• Recruitment Status: Unknown
• First Posted: January 19, 2021
• Last Update Posted: February 2, 2021
• Sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
• 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: January 13, 2021
• First Posted Date: January 19, 2021
• Last Update Posted Date: February 2, 2021
• Actual Study Start Date: January 15, 2021
• Estimated Primary Completion Date: July 20, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: An Open Study on the Safety, Tolerability, and Immunogenicity of "Sputnik Light" Vaccine
• 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
• 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: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: COVID-19 Prevention

Intervention

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

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

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: January 15, 2021): 110
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 31, 2021
• Estimated Primary Completion Date: July 20, 2021 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 111 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Russian Federation

Administrative Information

• NCT Number: NCT04713488
• Other Study ID Numbers: 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

• 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: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
• Original Study Sponsor: Same as current
• Collaborators: Russian Direct Investment Fund
• Investigators: Not Provided
• PRS Account: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
• Verification Date: January 2021