Official Title
A Randomized Double-blind Placebo-controlled Multi-center Clinical Trial in Parallel Assignment of Safety, Tolerability and Immunogenicity of a Vaccine "Gam-COVID-Vac, a Combined Vector Vaccine for the Prevention of Coronavirus Infection Caused by the SARS-CoV-2 Virus" in a Nasal Spray Dosage Form With the Participation of Adult Volunteers
Brief Summary

Randomized, double-blind, placebo-controlled trial to evaluate safety and immunogenicityof intranasal "Gam-COVID-Vak" combined vector vaccine for the prevention of coronavirusinfection caused by the SARS-CoV-2 virus.The duration of participation in the study for one subject will be 180±14 days after thefirst dose of vaccine, during which each subject will undergo a screening visit (within aweek) and face-to-face visits according to the study plan. Intranasal vaccineadministration will be done at day 1 vaccination visits and day 21±2 days on anoutpatient basis.During the follow-up visits key vital signs will be assessed, and will collect data onchanges in the state and well-being subjects from a previous visit. Subject data will becollected using electronic forms of individual registration cards, as well as with usingquestionnaires (diaries) filled by the subjects of the study.Immunogenicity will be assessed on day 1, 10, 28, 42 and 90 days. Humoral and cellularimmune response will be evaluated.

Detailed Description

Not Provided

Unknown status
COVID-19
SARS-CoV-2 Acute Respiratory Disease

Biological: Gam-COVID-Vac

two-component combined vector vaccine for the prevention of coronavirus infection caused
by the SARS-CoV-2 virus

Other: Placebo

solution with same composition as for vaccine formulation except rAds

Eligibility Criteria

Inclusion Criteria:

1. The presence of a written informed consent of the subject to participate in the
study;

2. Adult volunteers over 18;

3. Negative test result for HIV, hepatitis, syphilis;

4. Negative test result for COVID-2019, determined by PCR at the visit screening, and,
if available, the result of the examination performed in medical organizations that
are research centers 7 days before inclusion into research;

5. The result of the study for the presence of IgG antibodies to SARS CoV2 up to 10
VGR, which corresponds to value up to 100 BAU, regardless of the immune status
before;

6. Absence of contact of the research subject with patients with COVID-2019 for at
least 14 days before enrollment in the study (according to the study participant);

7. Consent to use effective methods of contraception during the entire period of
participation in research;

8. Negative Urine Pregnancy Test at Screening Visit (for women of childbearing age);

9. Negative test for the presence of narcotic and psychostimulant drugs in the urine
for screening visit;

10. Negative alcohol test at screening visit;

11. No history of severe post-vaccination reactions or post-vaccination complications
after the use of immunobiological preparations;

12. Absence of acute infectious and/or respiratory diseases for at least within 14 days
prior to enrollment in the study.

Exclusion Criteria:

1. Inability to give informed consent, inability to understand the essence of the study

2. Any vaccination/immunization carried out within 30 days prior to inclusion in study;

3. Steroid therapy (excluding hormonal contraceptives) and/or immunoglobulins or other
blood products, not completed 30 days before inclusion in the study;

4. COVID-2019 disease or vaccination to prevent COVID-2019 in less than six months
before inclusion in the study

5. Immunosuppressive drug therapy completed less than 3 months before inclusion in the
study;

6. Postponed less than one year prior to enrollment in the study acute coronary
syndrome or stroke;

7. Tuberculosis, chronic systemic infections;

8. Exacerbation of rhinitis

9. Burdened allergic history (presence in the anamnesis of information about
anaphylactic shock, angioedema, polymorphic exudative eczema, serum sickness),
hypersensitivity or allergic reactions to the introduction of immunobiological
drugs, known allergic reactions to drug components, exacerbation allergic diseases
on the day of inclusion in the study;

10. History of neoplasms (ICD codes C00-D09);

11. Donation of blood or plasma (in a volume of 450 ml or more) less than 2 months
before inclusion in the study;

12. Splenectomy in history;

13. Neutropenia (decrease in the absolute number of neutrophils less than 1000/mm3),
agranulocytosis, significant blood loss, severe anemia (hemoglobin less than 80
g/l), immunodeficiency in history within 6 months prior to enrollment in the study;

14. Subjects with active human immunodeficiency virus disease syphilis, hepatitis B and
C;

15. Anorexia, protein deficiency of any origin;

16. History of alcoholism and drug addiction;

17. Participation of the subject in any other interventional clinical trial during this
study;

18. Any other condition of the research subject that, in the opinion of the research
physician, may prevent completion of the study in accordance with the protocol;

19. Staff of research centers and other staff directly involved in conducting the study
(principal investigator and members of the research team) and members of their
families.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Locations

Not Provided

Contacts

Nadezhda L Lubenec
8 (499) 193-30-01
info@gamaleya.org

Not Provided

Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
NCT Number
Keywords
Vaccine
Sputnik
adenoviral vector vaccine
Intranasal Vaccine
MeSH Terms
Respiratory Tract Diseases
Respiration Disorders