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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

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ClinicalTrials.gov Identifier: NCT04587219
Recruitment Status : 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

Tracking Information
First Submitted Date  ICMJE October 13, 2020
First Posted Date  ICMJE October 14, 2020
Last Update Posted Date January 22, 2021
Actual Study Start Date  ICMJE October 22, 2020
Estimated Primary Completion Date March 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2020)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2020)
  • Changing of of virus neutralizing antibody titer [ Time Frame: at days 0, 28, 42 ]
    Determination of virus neutralizing antibody titer
  • Changing of antigen-specific cellular immunity level [ Time Frame: Time Frame: at days 0,28 ]
    Determination of antigen-specific cellular immunity
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Study of "Gam-COVID-Vac" Vaccine Against COVID-19 With the Participation of Volunteers of 60 y.o and Older
Official Title  ICMJE 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
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Open prospective non-randomized study
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Coronavirus Infection
Intervention  ICMJE 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)
Study Arms  ICMJE 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.
Intervention: Biological: Gam-COVID-Vac
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 13, 2020)
110
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2021
Estimated Primary Completion Date March 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 111 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04587219
Other Study ID Numbers  ICMJE 05-Gam-COVID-Vac-2020
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Study Sponsor  ICMJE Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP