Safety, reactogenicity and immunogenicity study of the vector vaccine GamCovidVac for theprevention of coronavirus (COVID-19) infection caused by the SARS-CoV-2 virus withaltered antigenic profile with participation of adult volunteers
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Biological: GamCovidVac vector vaccine for the prevention of COVID-19 (with altered antigenic profile)
Two intramuscular injections of the GamCovidVac vector vaccine for the prevention of
COVID-19 (with altered antigenic profile) will be performed. 1st injection - component I,
2nd injection - component II.
Inclusion Criteria:
The study will include volunteers who meet all the specified criteria:
1. Written informed consents to participate in the Study;
2. Adult volunteers men and women over 18 years old;
3. A negative test result for COVID-19, determined by PCR or express method before the
introduction of the investigational medicinal product (IMP);
4. Consent to the use of effective methods of contraception during the entire period of
participation in the Study;
5. A negative pregnancy test based on the results of a urine test at a screening visit
(for women with preserved reproductive potential);
6. Negative test for the presence of narcotic and psychostimulants in the urine at the
screening visit;
7. Negative alcohol content test at the screening visit;
8. Any vaccination not earlier than the last 30 days before inclusion in the Study;
9. No contraindications to vaccination;
10. 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:
1. No written informed consents to participate in the Study
2. 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;
3. Therapy with any immunosuppressive drugs completed less than 3 months prior to
inclusion in the Study;
4. Female volunteers during pregnancy or lactation;
5. Acute coronary syndrome or stroke suffered less than one year prior to inclusion in
the Study;
6. Tuberculosis, chronic systemic infections (according to anamnesis);
7. Burdened allergic anamnesis (record of anaphylactic shock, Quincke's edema,
polymorphic exudative eczema, serum sickness in the anamnesis), hypersensitivity or
allergic reactions to the administration of immunobiological drugs, known allergic
reactions to any of the components of the vaccine or vaccine containing similar
components, exacerbation of allergic diseases on the day of inclusion in the Study;
8. The presence of neoplasms (ICD codes C00-D09) (according to anamnesis);
9. Splenectomy (according to the anamnesis);
10. Neutropenia (decrease in the absolute number of neutrophils less than 1000 cells /
mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin
concentration less than 80 g/l) - 6 month prior to inclusion in the Study (according
to the anamnesis);
11. Volunteers with an active form of the disease caused by the human immunodeficiency
virus, syphilis, hepatitis B and C (according to the anamnesis);
12. Anorexia, protein deficiency of any origin;
13. Alcoholism and drug addiction (according to the anamnesis);
14. Participation in any other clinical trial 90 days prior to the screening;
15. 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);
16. Any other condition of the volunteer of the Study, which, in the opinion of the
research physician, may prevent the completion of the study in accordance with the
protocol;
17. Vaccination against COVID-19 or transmitted coronavirus infection (COVID-19) less
than 6 months prior to the screening;
18. Multiple administration of the Sputnik V vaccine, Sputnik Lite, or multiple
administration of any other COVID-19 vaccine for more than three injections (Sputnik
V vaccination plus Sputnik Lite revaccination);
19. Inability to read in Russian; inability or unwillingness to understand the essence
of the Study;
20. Any other conditions that limit the validity of obtaining informed consent or may
affect the ability of a volunteer to participate in the Study.
21. Staff of research centers (chief researcher and members of the research team)
directly involved in the research and their family members.
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