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Clinical Trial of Efficacy, Safety, and Immunogenicity of Gam-COVID-Vac Vaccine Against COVID-19 in Belarus

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04564716
Recruitment Status : Active, not recruiting
First Posted : September 25, 2020
Last Update Posted : December 2, 2020
Sponsor:
Collaborators:
Russian Direct Investment Fund
CRO: iPharma
Information provided by (Responsible Party):
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Tracking Information
First Submitted Date  ICMJE September 24, 2020
First Posted Date  ICMJE September 25, 2020
Last Update Posted Date December 2, 2020
Actual Study Start Date  ICMJE September 28, 2020
Estimated Primary Completion Date March 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2020)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2020)
  • 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
  • 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
  • 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
  • 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
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 Clinical Trial of Efficacy, Safety, and Immunogenicity of Gam-COVID-Vac Vaccine Against COVID-19 in Belarus
Official Title  ICMJE Сlinical Trial of Efficacy, Safety and Immunogenicity of Combined Vector Vaccine Gam-COVID-Vac in SARS-СoV-2 Infection Prophylactic Treatment in Republic of Belarus
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

Overall of 110 volunteers aged 18 to 60 should be screened taking into account possible early departure from the study. It is supposed that 100 subjects will complete all screening procedures and will be randomized in a 3:1 ratio into two groups: a control group (using placebo, 25 subjects) and a study group (using Gam-COVID-Vac Combined Vector Vaccine to Prevent Coronavirus Infection Caused by SARS-CoV-2", 75 subjects).

The duration of participation in the study for one subject will be 180±14 days after the first dose of IMP/placebo, during which each subject will undergo a screening visit and five face-to-face visits to the doctor-researcher. Intramuscular injection of IMP or placebo will be carried out on vaccination visits N 1 and N 2 (Day 0 and Day 21±2). Further observation visits No 3, 4, 5 will be conducted on days 28±2, 42±2 and 180±14 respectively. It is allowed to conduct observation visits No. 3, 4 via telephone contact (TC). During the monitoring visits, all subjects of the study will be assessed on key vital indicators and data will be collected on changes in the status and well-being of the subjects since the previous visit.

The duration of participation in the study for one subject will be 180±14 days after the first dose of IMP/placebo, during which each subject will undergo a screening visit and five observation visits. Intramuscular injection of IMP or placebo will be carried out on vaccination visits N 1 and N 2 (Day 0 and Day 21±2). Further observation visits No 3, 4, 5 will be conducted on days 28±2, 42±2 and 180±14 respectively.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized double-blind placebo-controlled
Masking: Double (Participant, Investigator)
Masking Description:
Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Covid19
Intervention  ICMJE
  • Biological: Gam-COVID-Vac
    vaccine for intramuscular injection
  • Other: Placebo
    placebo comparator
Study Arms  ICMJE
  • 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)
    Intervention: Biological: Gam-COVID-Vac
  • Placebo Comparator: Control Group
    placebo, 0,5ml/dose+0,5 ml/dose immunization in days 1 and 21
    Intervention: Other: Placebo
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: September 24, 2020)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 10, 2021
Estimated Primary Completion Date March 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The subject's written informed consent to participate in the study;
  • Male and female subjects between the ages of 18 and 60 years (inclusive).
  • A negative test result for HIV, hepatitis, syphilis;
  • Negative result of research on antibodies IgM and IgG to SARS Cov2 by enzyme-linked immunosorbent assay;
  • A negative result of the COVID-2019 study, as determined by the PCR method at the screening visit;
  • Lack of COVID-2019 in anamnesis;
  • Lack of contact of the subject with COVID-2019 patients for at least 14 days before inclusion in the study (according to the participant);
  • Agreement to use effective contraceptive methods throughout the study period;
  • Negative pregnancy test based on the results of a urine test at a screening visit (for women of childbearing age);
  • A negative test for the presence of narcotic substances and psycho-stimulating drugs in the urine at the screening visit;
  • Negative alcohol test at the screening visit;
  • Lack of pre-existing post-vaccination reactions or post-vaccination complications following the use of immunobiological drugs;
  • No acute infectious and/or respiratory diseases for at least 14 days before inclusion in the study.

Exclusion Criteria:

  • Any vaccination/immunization carried out within 30 days prior to enrollment in the study;
  • Treatment with steroids (except hormonal contraceptives) and/or with immunoglobulins or other blood products not completed 30 days before inclusion in the study;
  • Immunosuppressive therapy completed less than three months before inclusion in the study;
  • Female subjects during pregnancy or breastfeeding;
  • Acute coronary syndrome or stroke suffered less than one year before inclusion into the study;
  • Tuberculosis, chronic systemic infections;
  • Aggravated allergy anamnesis (anamnesis of anaphylactic shock, Quinque edema, polymorphic exudative eczema, atopia, serum disease), hypersensitivity or allergic reactions to immunobiological drugs, known allergic reactions to the components of the drug, aggravation of allergic diseases on the day of inclusion in the study;
  • The presence of neoplasms in the anamnesis (codes C00-D09);
  • Donated blood or plasma (450 ml or more) less than 2 months before inclusion in the study;
  • Splenectomy in anamnesis;
  • Neutropenia (decrease in absolute number of neutrophils less than 1000/mm3), agraneulocytosis, significant haemorrhage, severe anaemia (hemoglobin less than 80 g/l), immunodeficiency in anamnesis for 6 months before inclusion in the study;
  • Subjects with an active form of disease caused by human immunodeficiency virus, syphilis, hepatitis B and C;
  • Anorexia, protein deficiency of any origin;
  • Chronic autoimmune diseases or systemic collagenoses in anamnesis
  • Extensive tattoos at the injection site (deltoid region) that do not allow for an assessment of the local response to IMP/placebo administration;
  • Alcoholism and drug addiction in anamnesis;
  • Participation of the subject in any other interventional clinical trial;
  • Any other condition of the subject which, in the opinion of the researcher's medical practitioner, may prevent completion of the investigation according to the protocol;
  • Staff of research centers and other staff directly involved in the study and their families.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belarus
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04564716
Other Study ID Numbers  ICMJE 04-Gam-COVID-Vac-2020-RB
Has Data Monitoring Committee Yes
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 Not Provided
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
  • Russian Direct Investment Fund
  • CRO: iPharma
Investigators  ICMJE
Study Chair: Roman Plotnikov CRO: iPharma
PRS Account Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Verification Date September 2020

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