Clinical trial NCT04587219: The Study of "Gam-COVID-Vac" Vaccine Against COVID-19 With the Participation of Volunteers of 60 y.o and Older
Official title: An Open Study of the Safety, Tolerability and Immunogenicity of the "Gam-COVID-Vac"Vaccine Against COVID-19 (Solution for Intramuscular Injection) With the Participation of Volunteers in the Age Group Over 60 Years
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Coronavirus Infection
Keywords: COVID-19
vaccine
vector vaccine
Immunologic Factors
SARS-CoV-2
Lead sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 110
Sex: ALL
Minimum age (years): 60
Maximum age (years): 111
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open prospective non-randomized study
Primary purpose: PREVENTION

Brief summary: The purpose of this study: to assess the safety, tolerability and immunogenicity of the drug "Gam-COVID-Vac", a solution for intramuscular injection, at various times after vaccination in volunteers over 60 years of age

Detailed description: An open-ended prospective non-randomized study involving volunteers over the age of 60.

The study will include 110 volunteers. who will receive the test drug according to the prime-boost scheme: the introduction of component 1 will be carried out on the 1st day, and component 2 - on the 21st day of the study. Outpatient monitoring will be performed during 4 visits: on the 7th, 14th, 28th, and 42nd days after the vaccine administration Also two visits will be performed in the phone contact mode for 90 and 180 days

Eligibility criteria: Inclusion Criteria:

1. The written informed consent of the subject for participation in the study;
2. Men and women over the age of 60 years inclusive;
3. Negative result of research on HIV, hepatitis, syphilis;
4. negative test result for the presence of IgM and IgG antibodies to SARS CoV2 by enzyme immunoassay;
5. negative test result for COVID-2019, determined by PCR at the screening session;
6. The absence of a history COVID-2019;
7. No contact of the study subject with COVID-2019 patients for at least 14 days prior to inclusion in the study (according to the study participant);
8. Consent to use effective methods of contraception during the entire period of participation in the study;
9. A negative test for the presence of narcotic and psychoactive agents in urine at the screening visit;
10. A negative test for alcohol at screening visit;
11. negative pregnancy test (performed for women with preserved reproductive potential)
12. No history of severe postvaccinal reactions or postvaccinal complications after the use of immunobiological drugs;
13. absence of acute infectious and/or respiratory diseases for at least 14 days prior to inclusion in the study.

Exclusion Criteria:

1. any vaccination/immunization performed within 30 days prior to inclusion in The study;
2. therapy with steroids (with the exception of hormonal contraceptives and drugs used as hormone replacement therapy for menopause) and/or immunoglobulins or other blood products that did not end 30 days before inclusion in the study;
3. Therapy immunosuppressive drugs, which ended less than 3 months before inclusion in the study;
4. Subjects of the female gender during pregnancy or breastfeeding;
5. Postponed less than one year before inclusion in the study, acute coronary syndrome or stroke;
6. Tuberculosis, chronic systemic infections;
7. burdened allergic history (the presence in the history of information about anaphylactic shock, Quincke's edema, polymorphic exudative eczema, atopy, serum sickness), 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 inclusion in the study;
8. the presence of a history of neoplasms (ICD codes C00-D09);
9. donation of blood or plasma (450 ml or more) less than 2 months before inclusion in the study;
10. Splenectomy in history;
11. Neutropenia (decrease in the absolute number of neutrophils less than 1000/mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin less than 80 g/l), a history of immunodeficiency for 6 months before inclusion in the study;
12. Subjects with an active form of the disease caused by the human immunodeficiency virus, syphilis, hepatitis B and C;
13. Anorexia, protein deficiency of any origin;
14. extensive tattoos at the sites of drug administration (deltoid muscle area), which do not allow to assess the local response to the introduction of ILP;
15. Alcoholism and drug addiction in history;
16. Consists on the account at the psychiatrist;
17. subject's participation in any other interventional clinical trial within 90 days prior to the start of this study;
18. any other condition of the research subject that, in the opinion of the research doctor, may prevent the completion of the study in accordance with The Protocol;
19. staff of research centers and other employees directly involved in the research (members of the research team) and their families.
20. severe comorbid diseases that, in the opinion of the research doctor, may prevent participation in the study.

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Primary outcomes:
measure: Changing of antibody levels against the SARS-CoV-2 glycoprotein S in 42 days
timeFrame: at days 0, 21, 28, 42
measure: Number of Participants With Adverse Events
timeFrame: through the whole study, an average of 180 days
Secondary outcomes:
measure: Changing of of virus neutralizing antibody titer
timeFrame: at days 0, 28, 42
measure: Changing of antigen-specific cellular immunity level
timeFrame: Time Frame: at days 0,28
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Federal state budgetary institution "Central clinical hospital with polyclinic" Of the office Of the President of the Russian Federation
Study officials:
affiliation: Federal state budgetary institution "Central clinical hospital with polyclinic" Of the office Of the President of the Russian Federation
name: Nikita Lomakin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: