Clinical Trial of the Immunogenicity, Safety, and Efficacy of the Gam-COVID-Vac Vaccine Against COVID-19 in Venezuela (VENEZUELA)
Primary Purpose
Covid19
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Gam-COVID-Vac
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Covid19 focused on measuring vaccine, COVID-19, adenoviral vector, SARS-CoV-2, Ad26, Ad5, Heterologous prime-boost vaccination
Eligibility Criteria
Inclusion Criteria:
- Written informed consent of a subject to participate in the trial
- Males and females aged 18+
- Negative HIV, hepatitis, and syphilis test results
- A negative test result for the presence of IgM and IgG antibodies to SARS CoV2 by enzyme immunoassay
- A negative test result for COVID-2019 by PCR at screening visit
- No COVID-2019 in the medical history
- No contact with COVID-2019 persons within at least 14 days before the enrollment (according to trial subjects)
- Consent to use effective contraception methods during the trial
- Negative urine pregnancy test at the screening visit (for child-bearing age women)
- Negative drugs or psychostimulants urine test at the screening visit
- Negative alcohol test at the screening visit
- No evident vaccine-induced reactions or complications after receiving immunobiological products in the medical history
- No acute infectious and/or respiratory diseases within at least 14 days before the enrollment.
Exclusion Criteria:
- Any vaccination/immunization within 30 days before the enrollment;
- Steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrollment.
- Immunosuppressors therapy finished within 3 months before the enrollment
- Pregnancy or breast-feeding
- Acute coronary syndrome or stroke suffered less than one year before the enrollment
- Tuberculosis, chronic systemic infections
- 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
- Neoplasms in the medical history.
- Donated blood or plasma (450+ ml) within 2 months before the enrollment
- Splenectomy in the medical history
- Neutropenia (absolute neutrophil count <1,000 mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin <80 g/L), immunodeficiency in the medical history within 6 months before the enrollment
- Active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis B or C
- Anorexia, protein deficiency of any origin
- Big-size tattoos at the injection site (deltoid muscle area), which does not allow assessing the local response to the study drug/placebo administration
- Alcohol or drug addiction in the medical history
- Participation in any other interventional clinical trial.
- Any other condition that the study physician considers as a barrier to the trial completion as per the protocol
- Study center staff and other employees directly involved in the trial and their families.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vaccine Gam-COVID-Vac
Placebo
Arm Description
Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2 infection
Placebo
Outcomes
Primary Outcome Measures
Seroconversion rate
Percentage of trial subjects with fourfold or more increase in the titer of SARS-CoV-2 glycoprotein-specific antibodies in 2,000 trial subjects on the drug administration day before injecting the first dose of the study drug/placebo and 42±2 and 180±14 days after the first dose
Secondary Outcome Measures
Incidence and severity of adverse events
Incidence and severity of adverse events in trial subjects within 6 months after injecting the first dose of the study drug/placebo
Virus-neutralizing antibody levels against the SARS-CoV-2
Geometric mean virus-neutralizing antibodies titer in 500 trial subjects on the drug administration day before injecting the first dose of the study drug/placebo and 42±2 days after the first dose
Antibody levels against the SARS-CoV-2 glycoprotein
Geometric mean titer of the SARS-CoV-2 glycoprotein-specific antibodies in 2,000 trial subjects on the drug administration day before injecting the first dose of the study drug/placebo and 42±2 and 180±14 days after the first dose
Percentage of trial subjects with coronavirus disease 2019 (COVID-19)
Percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months, as confirmed with the method of polymerase chain reaction (PCR)
Full Information
NCT ID
NCT04642339
First Posted
November 16, 2020
Last Updated
November 23, 2020
Sponsor
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Collaborators
Ministerio del Poder Popular para la Salud de la República Bolivariana de Venezuela
1. Study Identification
Unique Protocol Identification Number
NCT04642339
Brief Title
Clinical Trial of the Immunogenicity, Safety, and Efficacy of the Gam-COVID-Vac Vaccine Against COVID-19 in Venezuela
Acronym
VENEZUELA
Official Title
Randomized, Double-blind, Placebo Controlled, Clinical Trial of the Immunogenicity, Safety, and Efficacy of the Gam-COVID-Vac Combined Vector Vaccine in Prophylactic Treatment for SARS-СoV-2 Infection
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 2020 (Anticipated)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Collaborators
Ministerio del Poder Popular para la Salud de la República Bolivariana de Venezuela
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Randomized, double-blind, placebo controlled clinical trial of immunogenicity, safety and efficacy of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults.
Detailed Description
Randomized, double-blind (blinded for trial subject and the study physician), placebo controlled clinical trial in parallel assignment of the immunogenicity, safety, and efficacy of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults.
The trial will include 2,000 volunteers over the age of 18. After screening, they will be randomised (3:1) into two groups - a reference group of 500 volunteers who will receive the placebo and a study group of 1,500 volunteers who will receive the combined Gam-COVID-Vac vaccine against SARS-induced coronavirus infection-СoV-2oV-2. 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 1 and day 21±2). Follow-up visits Nos. 3, 4, 5 will be conducted on days 28±2, 42±2 and 180±14, respectively. Blood samples will be taken from certain subjects during the following visits to assess the immunogenicity parameters on days 1, 42±2 and 180±14. During observation visits, vital indicators will be assessed on all trial subjects and changes in the subjects' condition and well-being will be recorded, observational visits may be remote, using telemedicine (TM) technologies. Additionally, the trial subjects will be able to have remote consultations with the study physician through the TM. Data from trial subjects will be collected through electronic case report forms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
vaccine, COVID-19, adenoviral vector, SARS-CoV-2, Ad26, Ad5, Heterologous prime-boost vaccination
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vaccine Gam-COVID-Vac
Arm Type
Experimental
Arm Description
Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2 infection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Biological
Intervention Name(s)
Gam-COVID-Vac
Other Intervention Name(s)
Sputnik V
Intervention Description
Gam-COVID-Vac combined vector vaccine, 0,5ml/dose+0,5 ml/dose prime-boost immunization with component I (rAd26-S) and component II (rAd5-S) with 21 days interval
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Seroconversion rate
Description
Percentage of trial subjects with fourfold or more increase in the titer of SARS-CoV-2 glycoprotein-specific antibodies in 2,000 trial subjects on the drug administration day before injecting the first dose of the study drug/placebo and 42±2 and 180±14 days after the first dose
Time Frame
42 day, 180 day
Secondary Outcome Measure Information:
Title
Incidence and severity of adverse events
Description
Incidence and severity of adverse events in trial subjects within 6 months after injecting the first dose of the study drug/placebo
Time Frame
through the study (till day 180)
Title
Virus-neutralizing antibody levels against the SARS-CoV-2
Description
Geometric mean virus-neutralizing antibodies titer in 500 trial subjects on the drug administration day before injecting the first dose of the study drug/placebo and 42±2 days after the first dose
Time Frame
42 day
Title
Antibody levels against the SARS-CoV-2 glycoprotein
Description
Geometric mean titer of the SARS-CoV-2 glycoprotein-specific antibodies in 2,000 trial subjects on the drug administration day before injecting the first dose of the study drug/placebo and 42±2 and 180±14 days after the first dose
Time Frame
42 day, 180 day
Title
Percentage of trial subjects with coronavirus disease 2019 (COVID-19)
Description
Percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months, as confirmed with the method of polymerase chain reaction (PCR)
Time Frame
through the study (till day 180)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Written informed consent of a subject to participate in the trial
Males and females aged 18+
Negative HIV, hepatitis, and syphilis test results
A negative test result for the presence of IgM and IgG antibodies to SARS CoV2 by enzyme immunoassay
A negative test result for COVID-2019 by PCR at screening visit
No COVID-2019 in the medical history
No contact with COVID-2019 persons within at least 14 days before the enrollment (according to trial subjects)
Consent to use effective contraception methods during the trial
Negative urine pregnancy test at the screening visit (for child-bearing age women)
Negative drugs or psychostimulants urine test at the screening visit
Negative alcohol test at the screening visit
No evident vaccine-induced reactions or complications after receiving immunobiological products in the medical history
No acute infectious and/or respiratory diseases within at least 14 days before the enrollment.
Exclusion Criteria:
Any vaccination/immunization within 30 days before the enrollment;
Steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrollment.
Immunosuppressors therapy finished within 3 months before the enrollment
Pregnancy or breast-feeding
Acute coronary syndrome or stroke suffered less than one year before the enrollment
Tuberculosis, chronic systemic infections
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
Neoplasms in the medical history.
Donated blood or plasma (450+ ml) within 2 months before the enrollment
Splenectomy in the medical history
Neutropenia (absolute neutrophil count <1,000 mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin <80 g/L), immunodeficiency in the medical history within 6 months before the enrollment
Active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis B or C
Anorexia, protein deficiency of any origin
Big-size tattoos at the injection site (deltoid muscle area), which does not allow assessing the local response to the study drug/placebo administration
Alcohol or drug addiction in the medical history
Participation in any other interventional clinical trial.
Any other condition that the study physician considers as a barrier to the trial completion as per the protocol
Study center staff and other employees directly involved in the trial and their families.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexis H García Piñero, MD
Phone
+582122191711
Email
alexisgarcia27@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Children's Cardiology Hospital "Dr. Gilberto Rodriguez Ochoa"
Phone
+582122191711
Email
presidencia@espromedbio.gob.ve
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexis H García Piñero, MD
Organizational Affiliation
Children's Cardiology Hospital "Dr. Gilberto Rodriguez Ochoa"
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Trial of the Immunogenicity, Safety, and Efficacy of the Gam-COVID-Vac Vaccine Against COVID-19 in Venezuela
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