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History of Changes for Study: NCT04530396
Clinical Trial of Efficacy, Safety, and Immunogenicity of Gam-COVID-Vac Vaccine Against COVID-19 (RESIST)
Latest version (submitted January 20, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 27, 2020 None (earliest Version on record)
2 August 28, 2020 Study Status and Contacts/Locations
3 September 1, 2020 Contacts/Locations and Study Status
4 September 4, 2020 Contacts/Locations and Study Status
5 September 10, 2020 Recruitment Status, Contacts/Locations and Study Status
6 September 17, 2020 Study Status, Contacts/Locations and Outcome Measures
7 September 22, 2020 Contacts/Locations and Study Status
8 October 23, 2020 Contacts/Locations, Outcome Measures, Study Description and Study Status
9 January 20, 2021 Recruitment Status, Contacts/Locations, Study Status and Study Design
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Study NCT04530396
Submitted Date:  August 27, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: 04-Gam-COVID-Vac-2020
Brief Title: Clinical Trial of Efficacy, Safety, and Immunogenicity of Gam-COVID-Vac Vaccine Against COVID-19 (RESIST)
Official Title: Randomized Double-blind Placebo-controlled Multi-center Clinical Trial in Parallel Assignment of Efficacy, Safety, and Immunogenicity of Gam-COVID-Vac Combined Vector Vaccine in SARS-СoV-2 Infection Prophylactic Treatment
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2020
Overall Status: Not yet recruiting
Study Start: August 31, 2020
Primary Completion: December 1, 2022 [Anticipated]
Study Completion: December 31, 2022 [Anticipated]
First Submitted: August 25, 2020
First Submitted that
Met QC Criteria:
August 27, 2020
First Posted: August 28, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
August 27, 2020
Last Update Posted: August 28, 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: Government of the city of Moscow
CRO: Crocus Medical BV
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: Randomized, double-blind (blinded for the trial subject and the study physician), placebo controlled, multi-center clinical trial in parallel assignment of efficacy, immunogenicity, and safety of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults in the SARS-СoV-2 infection prophylactic treatment.
Detailed Description:

Randomized, double-blind (blinded for the trial subject and the study physician), placebo controlled, multi-center clinical trial in parallel assignment of efficacy, immunogenicity, and safety of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults in the SARS-СoV-2 infection prophylactic treatment.

The trial will include 40,000 volunteers aged 18+. After screening, they will be randomized (3:1) into two groups - a reference group of 10,000 volunteers receiving placebo and a study group of 30,000 volunteers receiving the Gam-COVID-Vac combined vector vaccine against the SARS-СoV-2-induced coronavirus infection.

The trial subjects will be randomized into five age strata: 18-30, 31-40, 41-50, 51-60, and 60+ years.

Each subject will participate in the trial for 180±14 days after the first dose of the study drug/placebo and will have one screening visit and five on-site visits to the study physician during the said period. The study drug/placebo will be administered intramuscularly during vaccination visits 1 and 2 (day 0 and day 21±2). Subsequent observation visits 3, 4, and 5 will be made on days 28±2, 42±2, and 180±14 respectively. During the observation visits, vital signs will be assessed in all trial subjects and changes in the subjects' condition and wellbeing compared to the previous visit will be recorded. Observation visits 3, 4, and 5 may be remote, through the telemedicine consultation (TMC).

Additionally, the trial subjects will be able to have remote consultations with the physician through the TMC.

Blood samples will be taken from certain subjects during the following visits to assess the immunogenicity parameters listed below:

Virus-neutralizing activity (300 subjects) ×3 Interferon gamma (107 subjects) ×3 CD4 and CD8 cell count and ratio (50 subjects) SARS-CoV-2 glycoprotein-specific antibodies titer (9,520 subjects) ×3 Blood sampling will be performed on the day of injecting the first dose of the study drug/placebo immediately prior to the study drug administration Blood sampling for immunogenicity parameters assessment will be only carried out in specially selected study centers.

Blood samples for immunogenicity parameters assessment will be taken from 9,520 trial subjects. All four immunogenicity parameters may be assessed in one trial subject.

Trial subjects data will be collected using electronic case report forms and electronic questionnaires to be filled by trial subjects.

Open or close this module Conditions
Conditions: Covid19 Prevention
Keywords: COVID-19
vector vaccine
SARS-CoV-2
adenoviral vector
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Randomized double-blind placebo-controlled
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 40000 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Primary Group
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)
Biological: Gam-COVID-Vac
vaccine for intramuscular injection
Placebo Comparator: Control Group
placebo, 0,5ml/dose+0,5 ml/dose immunization in days 1 and 21
placebo
placebo comparator
Open or close this module Outcome Measures
Primary Outcome Measures:
1. percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months after the first dose
[ Time Frame: through the whole study, an average of 180 days ]

Demonstrate the superiority of Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection compared to placebo, based on the percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months after the first dose of the study drug/placebo, as confirmed with the method of polymerase chain reaction (PCR)
Secondary Outcome Measures:
1. the severity of the clinical course of COVID-19
[ Time Frame: through the whole study, an average of 180 days ]

Assess the efficacy of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus compared to placebo, based on the severity of the clinical course of COVID-19
2. Changing of antibody levels against the SARS-CoV-2 glycoprotein S
[ Time Frame: day before injecting the first dose of the study drug/placebo and 42±2 and 180±14 days after the first dose ]

Assess the immunogenicity of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection compared to placebo, based on the geometric mean titer of SARS-CoV-2 glycoprotein-specific antibodies
3. Changing of antigen-specific cellular immunity level
[ Time Frame: the drug administration day before injecting the first dose of the study drug/placebo and 28±2 days after the first dose ]

Describe the strength of cell-mediated immune response induced by the use of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection compared to placebo
4. Changing of of virus neutralizing antibody titer
[ Time Frame: the drug administration day before injecting the first dose of the study drug/placebo and 42±2 days after the first dose ]

Geometric mean virus-neutralizing antibodies titer
5. Incidence of adverse events in trial subjects
[ Time Frame: through the whole study, an average of 180 days ]

Incidence of adverse events in trial subjects compared to placebo
6. Severity of adverse events in trial subjects
[ Time Frame: through the whole study, an average of 180 days ]

Severity of adverse events in trial subjects compared to placebo
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 111 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  1. Written informed consent of a subject to participate in the trial
  2. Males and females aged ≥18 y.o.;
  3. Negative HIV, hepatitis, and syphilis test results
  4. Negative anti-SARS CoV2 IgM and IgG antibodies test carried out with the enzyme immunoassay method
  5. Negative COVID-2019 PCR test result at the screening visit
  6. No COVID-2019 in the past medical history
  7. No contact with COVID-2019 diseased persons within at least 14 days before the enrollment (according to trial subjects)
  8. Consent to use effective contraception methods during the trial
  9. Negative urine pregnancy test at the screening visit (for child-bearing age women)
  10. Negative drugs or psychostimulants urine test at the screening visit
  11. Negative alcohol test at the screening visit
  12. No evident vaccine-induced reactions or complications after receiving immunobiological products in the past medical history
  13. No acute infectious and/or respiratory diseases within at least 14 days before the enrollment.

Exclusion Criteria:

  1. Any vaccination/immunization within 30 days before the enrollment;
  2. Steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrollment
  3. Immunosuppressors therapy finished within 3 months before the enrollment
  4. Pregnancy or breast-feeding
  5. Acute coronary syndrome or stroke suffered less than one year before the enrollment
  6. Tuberculosis, chronic systemic infections
  7. Drug allergy (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, atopy, serum disease), hypersensitivity or allergic reaction to immunobiological products, known allergic reactions to study drug components, acute exacerbation of allergic diseases on the enrollment day
  8. Neoplasms in the past medical history (ICD codes C00-D09)
  9. Donated blood or plasma (450+ ml) within 2 months before the enrollment
  10. History of splenectomy;
  11. Neutropenia (absolute neutrophil count <1,000/mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin <80 g/L), immunodeficiency in the past medical history within 6 months before the enrollment
  12. Active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis B or C
  13. Anorexia, protein deficiency of any origin
  14. Big-size tattoos at the injection site (deltoid muscle area), which does not allow assessing the local response to the study drug/placebo administration
  15. Alcohol or drug addiction in the past medical history
  16. Participation in any other interventional clinical trial
  17. Any other condition that the study physician considers as a barrier to the trial completion as per the protocol
  18. Study center staff or other employees directly involved in the trial, or their families.

If a subject has any contraindications to vaccination based on the Guidelines on Detection, Investigation and Prevention, of Vaccination-induced Side Reactions (approved by the Ministry of Healthcare of Russia on Apr. 12, 2019, the vaccination may be postponed for a period of time specified in the document.

Open or close this module Contacts/Locations
Central Contact Person: Inna Dolzhikova, PhD
Telephone: 1933001
Email: i.dolzhikova@gmail.com
Study Officials: Elena Smolyarchuk, MD, PhD
Study Chair
Study Coordinator
Locations: Russian Federation
Branch of the limited liability company "Hadassah medical LTD"
Moscow, Russian Federation
Contact:Contact: Karin Mirzoev, MD
Medsi Group of companies joint-stock company"
Moscow, Russian Federation
Contact:Contact: Irina Shestakova, MD
State Budgetary Healthcare Institution, Moscow, Consultation and Diagnosis Polyclinic No. 121, Moscow Healthcare Department
Moscow, Russian Federation
State Budgetary Healthcare Institution, Moscow, M. Konchalovsky Municipal Clinical Hospital, Moscow Healthcare Department
Moscow, Russian Federation
Contact:Contact: Tatiana Shimonova, MD
State Budgetary Healthcare Institution, Moscow, M. Zhadkevich Municipal Clinical Hospital, Moscow Healthcare Department
Moscow, Russian Federation
State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 2, Moscow Healthcare Department
Moscow, Russian Federation
Contact:Contact: Semyon Maksimov, MD
State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 212, Moscow Healthcare Department
Moscow, Russian Federation
Contact:Contact: Irina Gagarina, MD
State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 220, Moscow Healthcare Department
Moscow, Russian Federation
Contact:Contact: Elena Nurmukhametova, MD, PhD
State Budgetary Healthcare Institution, Municipal Polyclinic No. 62, Moscow Healthcare Department
Moscow, Russian Federation
Contact:Contact: Marina Rusanova, 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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