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The Study of "Gam-COVID-Vac" Vaccine Against COVID-19 With the Participation of Volunteers of 60 y.o and Older

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04587219
Recruitment Status : Unknown
Verified October 2020 by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation.
Recruitment status was:  Active, not recruiting
First Posted : October 14, 2020
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Study Description
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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

Condition or disease Intervention/treatment Phase
Coronavirus Infection Biological: Gam-COVID-Vac Phase 2

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open prospective non-randomized study
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : October 22, 2020
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Gam COVID Vac Vaccine
the test drug will be administered according to the prime-boost scheme: the introduction of component 1 (Ad26) will be carried out on the 1st day, and component 2(Ad5)- on the 21st day of the study.
 Biological: Gam-COVID-Vac
combined vector vaccine, 0,5ml/dose+0,5 ml/dose prime-boost immunization in days 1 (component I rAd26-S) and 21(component II rAd5-S)


Outcome Measures
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Primary Outcome Measures :
  1. Changing of antibody levels against the SARS-CoV-2 glycoprotein S in 42 days [ Time Frame: at days 0, 21, 28, 42 ]
    Determination of antibody levels against the SARS-CoV-2 glycoprotein S measured by an ELISA vs. baseline values

  2. Number of Participants With Adverse Events [ Time Frame: through the whole study, an average of 180 days ]
    Determination of Number of Participants With Adverse Events


Secondary Outcome Measures :
  1. Changing of of virus neutralizing antibody titer [ Time Frame: at days 0, 28, 42 ]
    Determination of virus neutralizing antibody titer

  2. Changing of antigen-specific cellular immunity level [ Time Frame: Time Frame: at days 0,28 ]
    Determination of antigen-specific cellular immunity


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years to 111 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

    -

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04587219


Locations
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Russian Federation
Federal state budgetary institution "Central clinical hospital with polyclinic" Of the office Of the President of the Russian Federation
Moscow, Russian Federation
Sponsors and Collaborators
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Investigators
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Principal Investigator: Nikita Lomakin, MD, PhD Federal state budgetary institution "Central clinical hospital with polyclinic" Of the office Of the President of the Russian Federation
More Information
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Responsible Party: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
ClinicalTrials.gov Identifier: NCT04587219    
Other Study ID Numbers: 05-Gam-COVID-Vac-2020
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation:
COVID-19
vaccine
vector vaccine
Immunologic Factors
SARS-CoV-2
Additional relevant MeSH terms:
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COVID-19
Coronavirus Infections
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
 Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases