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History of Changes for Study: NCT04436471
An Open Study of the Safety, Tolerability and Immunogenicity of the Drug "Gam-COVID-Vac" Vaccine
Latest version (submitted August 11, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 17, 2020 None (earliest Version on record)
2 June 19, 2020 Arms and Interventions, Study Description, Study Status, Study Identification, Eligibility and Outcome Measures
3 July 2, 2020 Recruitment Status, Contacts/Locations, Study Status and Study Design
4 August 11, 2020 Recruitment Status and Study Status
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Study NCT04436471
Submitted Date:  June 17, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: 02-Gam-COVID-Vac-2020
Brief Title: An Open Study of the Safety, Tolerability and Immunogenicity of the Drug "Gam-COVID-Vac" Vaccine
Official Title: An Open Study of the Safety, Tolerability and Immunogenicity of the Drug "Gam-COVID-Vac" Lyophilizate for the Preparation of a Solution for Intramuscular Injection With the Participation of Healthy Volunteers
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2020
Overall Status: Recruiting
Study Start: June 17, 2020
Primary Completion: August 5, 2020 [Anticipated]
Study Completion: August 15, 2020 [Anticipated]
First Submitted: June 16, 2020
First Submitted that
Met QC Criteria:
June 17, 2020
First Posted: June 18, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
June 17, 2020
Last Update Posted: June 18, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Responsible Party: Sponsor
Collaborators: Acellena Contract Drug Research and Development
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: The purpose of this study: to evaluate the safety, tolerability and immunogenicity of the drug "Gam-COVID-Vac", a solution for intramuscular administration, at various times after vaccination in healthy adult volunteers.
Detailed Description:

An open, prospective, two-stage, non-randomized, first-phase study involving healthy volunteers.

Phase one

  1. the First group, 9 volunteers, will receive the drug, a solution for intramuscular administration, in the mode of single immunization with component 1 in a full therapeutic dose.
  2. the Second group, 9 volunteers, will receive the drug, a solution for intramuscular administration, in the mode of single immunization with component 2 in the full therapeutic dose.

The studied drugs will be administered to a total of 18 volunteers in a hospital setting and after administration, the drug's safety will be continuously monitored for 5 days. Based on the results of the safety assessment, the Chief investigator decides to proceed to the second stage of the study on the 5th day after the introduction of the studied drugs.

Second stage The second stage will include 20 volunteers and three understudies. Volunteers of the second stage will be vaccinated no earlier than 5 days after vaccination of participants of the first stage.

Volunteers participating in the second stage of the study (a total of 20 people) will receive the study drug according to the booster scheme: the introduction of component 1 will be carried out on day 1, and component 2-on the 21st day of the study. Follow-up will be carried out during 4 visits: on 7, 14, 28, 42 days after administration of the drug.

Open or close this module Conditions
Conditions: Preventive Immunization COVID-19
Keywords: COVID-19
SARS-CoV-2
vector vaccine
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 1/Phase 2
Interventional Study Model: Parallel Assignment
An open, prospective, two-stage, non-randomized, first-phase study involving healthy volunteers
Number of Arms: 3
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 38 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Compound 1
rAd26 Compound, 1 vaccination
Biological: Gam-COVID-Vac
adenoviral-based vaccine against SARS-CoV-2
Experimental: Compound 2
rAd5 Compound, 1 vaccination
Biological: Gam-COVID-Vac
adenoviral-based vaccine against SARS-CoV-2
Experimental: Prime-Boost Immunization
Day 1 rAd26 Compound Day 21 rAd5 Compound
Biological: Gam-COVID-Vac
adenoviral-based vaccine against SARS-CoV-2
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Changing ofantibody levels against the SARS-CoV-2 glycoprotein S in 42 days
[ Time Frame: at days 0,14, 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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 60 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  1. men and women aged 18 to 60 years;
  2. written informed consent;
  3. body mass index (BMI) is 18.5≤BMI≤30;
  4. negative result of the COVID-2019 study by PCR (screening);
  5. the absence in the anamnesis of disease COVID-2019;
  6. no contact of volunteers with COVID-2019 patients for at least 14 days;
  7. negative results of tests for IDM and IgG antibodies to SARS-CoV-2;
  8. consent to use effective methods of contraception during the entire period of participation in the study;
  9. absence of acute infectious diseases at the time of vaccination and 14 days before the date of vaccination;
  10. negative pregnancy test based on blood or urine tests (for women of childbearing age);
  11. negative tests for HIV, hepatitis B and C, syphilis or confirmed medical history;
  12. negative urine test for traces of drugs;
  13. a negative test for alcohol content in exhaled air;
  14. absence of malignant diseases of any nature and localization;
  15. absence in the history, as well as according to the screening examination, of pathology from the gastrointestinal tract, liver, kidneys, cardiovascular system, Central nervous system, musculoskeletal system, genitourinary, immune and endocrine systems, blood, which, from the point of view of the researcher and/or the study organizer, may affect the safety of the volunteer and the evaluation of the results of the study (clinical, instrumental and laboratory studies did not reveal diseases or clinically significant deviations).

Exclusion Criteria:

  1. participation of a volunteer in any other study in the last 90 days (from the date of admission of the individual entrepreneur);
  2. any vaccination in the last 30 days;
  3. a history of the disease COVID-2019;
  4. positive test result for SARS-CoV-2 by PCR (screening);
  5. positive results of tests for IDM and IgG antibodies to SARS-CoV-2;
  6. personnel of medical institutions who are in contact with persons who have become ill with COVID-2019;
  7. symptoms of respiratory illness in the last 14 days;
  8. administration of immunoglobulins or other blood products in the last 3 months;
  9. regular past or current use of narcotic drugs;
  10. taking immunosuppressive drugs and / or immunomodulators for 6 months before the start of the study;
  11. pregnancy or breast-feeding;
  12. exacerbation of allergic diseases at the time of vaccination;
  13. systolic blood pressure less than 100 mmHg or higher than 139 mmHg; diastolic blood pressure less than 60 mmHg or higher than 90 mmHg; heart rate less than 60 BPM or more than 100 BPM;
  14. severe allergic history (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, atopy, serum sickness in the anamnesis, hypersensitivity or allergic reactions to the administration of immunobiological drugs, known allergic reactions to the components of the drug, etc.);
  15. autoimmune diseases in the history of the volunteer and relatives of 1-2 degrees of kinship
  16. Smoking: more than 10 cigarettes a day;
  17. alcohol intake exceeding the low-risk level: no more than 20 grams of pure alcohol per day, no more than 5 days a week, alcohol intake within 48 hours before administration of the test drug;
  18. planned hospitalization and / or surgery during the period of participation in the study, as well as 4 weeks before the expected date of administration of the drug;
  19. the presence of a concomitant disease that may affect the evaluation of the results of the study;
  20. any conditions that, in the opinion of the researcher's doctor, may be a contraindication to participation in the study.
Open or close this module Contacts/Locations
Central Contact Person: Inna Dolzhikova, PhD
Telephone: 1933001 Ext. 499
Email: info@gamaleya.org
Locations: Russian Federation
Main military clinical hospital named after academician N. N. Burdenko
[Recruiting]
Moscow, Russian Federation
Contact:Contact: Irina Gagarina, MD 193 30 01 Ext. 499 info@gamaleya.org
Contact:Principal Investigator: Irina Gagarina, MD
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Links:
Available IPD/Information:

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