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Clinical Trial of Efficacy, Safety, and Immunogenicity of Gam-COVID-Vac Vaccine Against COVID-19 (RESIST)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04530396
Recruitment Status : Recruiting
First Posted : August 28, 2020
Last Update Posted : October 27, 2020
Sponsor:
Collaborators:
Government of the city of Moscow
CRO: Crocus Medical BV
Information provided by (Responsible Party):
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

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.

Condition or disease Intervention/treatment Phase
Covid19 Prevention Biological: Gam-COVID-Vac Other: placebo Phase 3

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.

The PCR test for SARS-CoV-2 RNA detection at the visit is performed during screening and before the second administration of the vaccine/placebo

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 days14±2, 28±2, 35±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 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 Determination of the titer of SARS-CoV-2 nucleocleocapsid protein-specific antibodies(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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized double-blind placebo-controlled
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : September 7, 2020
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Other: placebo
placebo comparator




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 second 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

  7. estimation of the proportion of study subjects with antibodies to the N-protein of the virus SARS-CoV-2 [ Time Frame: day before injecting the first dose of the study drug/placebo and 42±2 and 180±14 days after the first dose ]

    Percentage of study subjects with antibodies

    to the N-protein of the SARS - CoV-2 virus that appeared after

    vaccination




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:   18 Years to 111 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.


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): NCT04530396


Contacts
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Contact: Inna Dolzhikova, PhD 1933001 i.dolzhikova@gmail.com

Locations
Show Show 23 study locations
Sponsors and Collaborators
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Government of the city of Moscow
CRO: Crocus Medical BV
Investigators
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Study Chair: Elena Smolyarchuk, MD, PhD Study Coordinator
Study Chair: Sergey Zyryanov, MD, PhD Study Coordinator
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Responsible Party: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
ClinicalTrials.gov Identifier: NCT04530396    
Other Study ID Numbers: 04-Gam-COVID-Vac-2020
First Posted: August 28, 2020    Key Record Dates
Last Update Posted: October 27, 2020
Last Verified: August 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
vector vaccine
SARS-CoV-2
adenoviral vector