Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04587219
Other study ID # 05-Gam-COVID-Vac-2020
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date October 22, 2020
Est. completion date April 30, 2021

Study information

Verified date October 2020
Source Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 110
Est. completion date April 30, 2021
Est. primary completion date March 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 111 Years
Eligibility 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. -

Study Design


Related Conditions & MeSH terms


Intervention

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)

Locations

Country Name City State
Russian Federation Federal state budgetary institution "Central clinical hospital with polyclinic" Of the office Of the President of the Russian Federation Moscow

Sponsors (1)

Lead Sponsor Collaborator
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changing of antibody levels against the SARS-CoV-2 glycoprotein S in 42 days Determination of antibody levels against the SARS-CoV-2 glycoprotein S measured by an ELISA vs. baseline values at days 0, 21, 28, 42
Primary Number of Participants With Adverse Events Determination of Number of Participants With Adverse Events through the whole study, an average of 180 days
Secondary Changing of of virus neutralizing antibody titer Determination of virus neutralizing antibody titer at days 0, 28, 42
Secondary Changing of antigen-specific cellular immunity level Determination of antigen-specific cellular immunity Time Frame: at days 0,28
See also
  Status Clinical Trial Phase
Completed NCT04369456 - Blood Biomarkers as Predictors of COVID-19 Disease Progression in Recently Infected Kidney Transplant Patients N/A
Completed NCT04527471 - Pilot Study of Ensifentrine or Placebo Delivered Via pMDI in Hospitalized Patients With COVID-19 Phase 2
Recruiting NCT04410510 - P2Et Extract in the Symptomatic Treatment of Subjects With COVID-19 Phase 2/Phase 3
Withdrawn NCT04383899 - Role of Ibuprofen and Other Medicines on Severity of Coronavirus Disease 2019
Completed NCT04542915 - COVID-19-Related Health and Practices Among Dental Hygienists
Not yet recruiting NCT04400019 - Prevention of COVID19 Infection in Nursing Homes by Chemoprophylaxis With Hydroxychloroquine (PREVICHARM) Phase 2/Phase 3
Terminated NCT04954014 - Pilot Study of Single Dose Bevacizumab as Treatment for Acute Respiratory Distress Syndrome (ARDS) in COVID-19 Patients Phase 2
Suspended NCT04385771 - Cytokine Adsorption in Patients With Severe COVID-19 Pneumonia Requiring Extracorporeal Membrane Oxygenation N/A
Completed NCT04532632 - Taste and Smell Impairment in Critically Ill COVID-19 Patients
Terminated NCT04530448 - Coronavirus Induced Acute Kidney Injury: Prevention Using Urine Alkalinization Phase 4
Completed NCT04413435 - Clinical Characteristics of Critically Ill Patients With COVID-19
Terminated NCT05593770 - International Sites: Novel Experimental COVID-19 Therapies Affecting Host Response Phase 2/Phase 3
Completed NCT04510493 - Canakinumab in Patients With COVID-19 and Type 2 Diabetes Phase 3
Withdrawn NCT05430958 - Safety, Tolerability and Immunogenicity of INO-4800 for COVID19 in Healthy Volunteers Phase 1
Completed NCT04596579 - SARS-CoV-2 (COVID-19) Immune Surveillance Among a Population Based Sample of Adults in Florida
Completed NCT04405934 - COG-UK Project Hospital-Onset COVID-19 Infections Study N/A
Enrolling by invitation NCT04484025 - SPI-1005 Treatment in Moderate COVID-19 Patients Phase 2
Terminated NCT04442230 - NasoVAX in Patients With Early Coronavirus Infectious Disease 2019 (COVID-19) Phase 2
Terminated NCT04642638 - Safety, Immunogenicity, and Efficacy of INO-4800 for COVID-19 in Adults at High Risk of SARS-CoV-2 Exposure Phase 2/Phase 3
Active, not recruiting NCT04527432 - COVID-19 Health Professional Impact Study N/A