Official Title
Randomized Double-blind Placebo-controlled Multi-center Clinical Trial in Parallel Assignment of Efficacy, Safety, and Immunogenicity of Gam-COVID-Vac Combined Vector Vaccine in SARS-СoV-2 Infection Prophylactic Treatment
Brief Summary

Randomized, double-blind (blinded for the trial subject and the study physician), placebo controlled, multi-center clinical trial in parallel assignment of efficacy, immunogenicity, and safety of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults in the SARS-СoV-2 infection prophylactic treatment.

Detailed Description

Randomized, double-blind (blinded for the trial subject and the study physician), placebo
controlled, multi-center clinical trial in parallel assignment of efficacy, immunogenicity,
and safety of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced
coronavirus infection in adults in the SARS-СoV-2 infection prophylactic treatment.

The trial will include 40,000 volunteers aged 18+. After screening, they will be randomized
(3:1) into two groups - a reference group of 10,000 volunteers receiving placebo and a study
group of 30,000 volunteers receiving the Gam-COVID-Vac combined vector vaccine against the
SARS-СoV-2-induced coronavirus infection.

The trial subjects will be randomized into five age strata: 18-30, 31-40, 41-50, 51-60, and
60+ years.

The PCR test for SARS-CoV-2 RNA detection at the visit is performed during screening and
before the second administration of the vaccine/placebo

Each subject will participate in the trial for 180±14 days after the first dose of the study
drug/placebo and will have one screening visit and five on-site visits to the study physician
during the said period. The study drug/placebo will be administered intramuscularly during
vaccination visits 1 and 2 (day 0 and day 21±2). Subsequent observation visits 3, 4, and 5
will be made on days14±2, 28±2, 35±2,42±2, and 180±14 respectively. During the observation
visits, vital signs will be assessed in all trial subjects and changes in the subjects'
condition and wellbeing compared to the previous visit will be recorded. Observation visits
may be remote, through the telemedicine consultation (TMC).

Additionally, the trial subjects will be able to have remote consultations with the physician
through the TMC.

Blood samples will be taken from certain subjects during the following visits to assess the
immunogenicity parameters listed below:

Virus-neutralizing activity (300 subjects) ×3 Interferon gamma (107 subjects) ×3 CD4 and CD8
cell count and ratio (50 subjects) SARS-CoV-2 glycoprotein-specific antibodies titer (9,520
subjects) ×3 Determination of the titer of SARS-CoV-2 nucleocleocapsid protein-specific
antibodies(9,520 subjects) ×3

Blood sampling will be performed on the day of injecting the first dose of the study
drug/placebo immediately prior to the study drug administration Blood sampling for
immunogenicity parameters assessment will be only carried out in specially selected study
centers.

Blood samples will be taken from 9,520 trial subjects. All four immunogenicity parameters may
be assessed in one trial subject.

Trial subjects data will be collected using electronic case report forms and electronic
questionnaires to be filled by trial subjects.

Unknown status
Covid19 Prevention

Biological: Gam-COVID-Vac

vaccine for intramuscular injection

Other: placebo

placebo comparator

Eligibility Criteria

Inclusion Criteria:

1. Written informed consent of a subject to participate in the trial

2. Males and females aged ≥18 y.o.;

3. Negative HIV, hepatitis, and syphilis test results

4. Negative anti-SARS CoV2 IgM and IgG antibodies test carried out with the enzyme
immunoassay method

5. Negative COVID-2019 PCR test result at the screening visit

6. No COVID-2019 in the past medical history

7. No contact with COVID-2019 diseased persons within at least 14 days before the
enrollment (according to trial subjects)

8. Consent to use effective contraception methods during the trial

9. Negative urine pregnancy test at the screening visit (for child-bearing age women)

10. Negative drugs or psychostimulants urine test at the screening visit

11. Negative alcohol test at the screening visit

12. No evident vaccine-induced reactions or complications after receiving immunobiological
products in the past medical history

13. No acute infectious and/or respiratory diseases within at least 14 days before the
enrollment.

Exclusion Criteria:

1. Any vaccination/immunization within 30 days before the enrollment;

2. Steroids (except hormonal contraceptives) and/or immunoglobulins or other blood
products therapy not finished 30 days before the enrollment

3. Immunosuppressors therapy finished within 3 months before the enrollment

4. Pregnancy or breast-feeding

5. Acute coronary syndrome or stroke suffered less than one year before the enrollment

6. Tuberculosis, chronic systemic infections

7. Drug allergy (anaphylactic shock, Quincke's edema, polymorphic exudative eczema,
atopy, serum disease), hypersensitivity or allergic reaction to immunobiological
products, known allergic reactions to study drug components, acute exacerbation of
allergic diseases on the enrollment day

8. Neoplasms in the past medical history (ICD codes C00-D09)

9. Donated blood or plasma (450+ ml) within 2 months before the enrollment

10. History of splenectomy;

11. Neutropenia (absolute neutrophil count <1,000/mm3), agranulocytosis, significant blood
loss, severe anemia (hemoglobin <80 g/L), immunodeficiency in the past medical history
within 6 months before the enrollment

12. Active form of a disease caused by the human immunodeficiency virus, syphilis,
hepatitis B or C

13. Anorexia, protein deficiency of any origin

14. Big-size tattoos at the injection site (deltoid muscle area), which does not allow
assessing the local response to the study drug/placebo administration

15. Alcohol or drug addiction in the past medical history

16. Participation in any other interventional clinical trial

17. Any other condition that the study physician considers as a barrier to the trial
completion as per the protocol

18. Study center staff or other employees directly involved in the trial, or their
families.

If a subject has any contraindications to vaccination based on the Guidelines on Detection,
Investigation and Prevention, of Vaccination-induced Side Reactions (approved by the
Ministry of Healthcare of Russia on Apr. 12, 2019, the vaccination may be postponed for a
period of time specified in the document.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 111 Years
Countries
Russian Federation
Locations

ARCHIMED V Clinic of new medical technologies limited liability company
Moscow, Russian Federation

Hadassah LTD
Moscow, Russian Federation

Medsi Group of companies joint-stock company"
Moscow, Russian Federation

Niarmedic Plus
Moscow, Russian Federation

State budgetary healthcare institution of the city of Moscow "City clinical hospital No. 52 of the Moscow city health Department"
Moscow, Russian Federation

State Budgetary Healthcare Institution, Moscow, Consultation and Diagnosis Polyclinic No. 121, Moscow Healthcare Department
Moscow, Russian Federation

State Budgetary Healthcare Institution, Moscow, M. Konchalovsky Municipal Clinical Hospital, Moscow Healthcare Department
Moscow, Russian Federation

State Budgetary Healthcare Institution, Moscow, M. Zhadkevich Municipal Clinical Hospital, Moscow Healthcare Department
Moscow, Russian Federation

State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 115, Moscow Healthcare Department
Moscow, Russian Federation

State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 2, Moscow Healthcare Department
Moscow, Russian Federation

State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 210, Moscow Healthcare Department
Moscow, Russian Federation

State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 212, Moscow Healthcare Department
Moscow, Russian Federation

State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 219, Moscow Healthcare Department
Moscow, Russian Federation

State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 220, Moscow Healthcare Department
Moscow, Russian Federation

State Budgetary Healthcare Institution, Municipal Polyclinic No. 62, Moscow Healthcare Department
Moscow, Russian Federation

State budgetary institution of health care of the city of Moscow " city polyclinic No. 109 Of the Department of health of the city of Moscow"
Moscow, Russian Federation

State budgetary institution of health care of the city of Moscow " city polyclinic No. 170 Of the Department of health of the city of Moscow"
Moscow, Russian Federation

State budgetary institution of health care of the city of Moscow " city polyclinic No. 36 Of the Department of health of the city of Moscow"
Moscow, Russian Federation

State budgetary institution of health care of the city of Moscow " city polyclinic No. 46 Of the Department of health of the city of Moscow"
Moscow, Russian Federation

State budgetary institution of health care of the city of Moscow " city polyclinic No. 6 Of the Department of health of the city of Moscow"
Moscow, Russian Federation

State budgetary institution of health care of the city of Moscow " city polyclinic No. 68 Of the Department of health of the city of Moscow"
Moscow, Russian Federation

State budgetary institution of health care of the city of Moscow "Diagnostic center No. 5 with polyclinic Department Of the Department of health of the city of Moscow"
Moscow, Russian Federation

State budgetary institution of health care of the city of Moscow "Diagnostic clinical center No. 1 Of the Department of health of the city of Moscow"
Moscow, Russian Federation

Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
NCT Number
Keywords
Covid-19
vector vaccine
SARS-CoV-2
adenoviral vector
MeSH Terms
COVID-19