Status:
UNKNOWN
An Open Study on the Safety, Tolerability, and Immunogenicity of "Sputnik Light" Vaccine
Lead Sponsor:
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Collaborating Sponsors:
Russian Direct Investment Fund
Conditions:
COVID-19 Prevention
Eligibility:
All Genders
18-111 years
Phase:
PHASE1
PHASE2
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 instru...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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;
- Large tattoos at the injection site (deltoid muscle area), which does not allow assessing the localized response to administering the study drug/placebo
- Alcohol or drug addiction in the person's medical history;
- Registered with a psychiatrist
- Participation in any other interventional clinical Trial within 90 days before the start of this trial
- Any other condition that the researching physician considers to be a hindrance to completing the trial as per the protocol;
- Research facility staff and other employees directly involved in the trial (research team members) and their families.
- Any related conditions that, in the opinion of the study physician, could serve as a hindrance to participating in the trial.
Key Trial Info
Start Date :
January 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2021
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04713488
Start Date
January 15 2021
End Date
July 31 2021
Last Update
February 2 2021
Active Locations (1)
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1
ECO-Safety
Saint Petersburg, Russia