Clinical Trial of the Immunogenicity, Safety, and Efficacy of the Gam-COVID-Vac Vaccine Against COVID-19 in Venezuela
VENEZUELA
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
1 other identifier
interventional
2,000
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 covid19
Started Nov 2020
Typical duration for phase_3 covid19
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2020
CompletedFirst Submitted
Initial submission to the registry
November 16, 2020
CompletedFirst Posted
Study publicly available on registry
November 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedNovember 24, 2020
November 1, 2020
11 months
November 16, 2020
November 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
42 day, 180 day
Secondary Outcomes (4)
Incidence and severity of adverse events
through the study (till day 180)
Virus-neutralizing antibody levels against the SARS-CoV-2
42 day
Antibody levels against the SARS-CoV-2 glycoprotein
42 day, 180 day
Percentage of trial subjects with coronavirus disease 2019 (COVID-19)
through the study (till day 180)
Study Arms (2)
Vaccine Gam-COVID-Vac
EXPERIMENTALGam-COVID-Vac combined vector vaccine against the SARS-CoV-2 infection
Placebo
PLACEBO COMPARATORPlacebo
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Franco C, Cornejo A, Rodriguez M, Garcia A, Belisario I, Mayora S, Garzaro DJ, Jaspe RC, Hidalgo M, Parra N, Liprandi F, Zambrano JL, Rangel HR, Pujol FH. Sputnik V-Induced Antibodies against SARS-CoV-2 Variants during the Dissemination of the Gamma Variant in Venezuela. Viruses. 2024 Sep 18;16(9):1480. doi: 10.3390/v16091480.
PMID: 39339956DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexis H García Piñero, MD
Children's Cardiology Hospital "Dr. Gilberto Rodriguez Ochoa"
Central Study Contacts
Children's Cardiology Hospital "Dr. Gilberto Rodriguez Ochoa"
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2020
First Posted
November 24, 2020
Study Start
November 1, 2020
Primary Completion
October 1, 2021
Study Completion
December 1, 2021
Last Updated
November 24, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share