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Clinical Trial of the Immunogenicity, Safety, and Efficacy of the Gam-COVID-Vac Vaccine Against COVID-19 in Venezuela (VENEZUELA)

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ClinicalTrials.gov Identifier: NCT04642339
Recruitment Status : Not yet recruiting
First Posted : November 24, 2020
Last Update Posted : November 24, 2020
Sponsor:
Collaborator:
Ministerio del Poder Popular para la Salud de la República Bolivariana de Venezuela
Information provided by (Responsible Party):
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Tracking Information
First Submitted Date  ICMJE November 16, 2020
First Posted Date  ICMJE November 24, 2020
Last Update Posted Date November 24, 2020
Estimated Study Start Date  ICMJE November 2020
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2020)
Seroconversion rate [ Time Frame: 42 day, 180 day ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2020)
  • Incidence and severity of adverse events [ Time Frame: through the study (till day 180) ]
    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 [ Time Frame: 42 day ]
    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 [ Time Frame: 42 day, 180 day ]
    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) [ Time Frame: through the study (till day 180) ]
    Percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months, as confirmed with the method of polymerase chain reaction (PCR)
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 the Immunogenicity, Safety, and Efficacy of the Gam-COVID-Vac Vaccine Against COVID-19 in Venezuela
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Covid19
Intervention  ICMJE
  • Biological: Gam-COVID-Vac
    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
    Other Name: Sputnik V
  • Biological: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Vaccine Gam-COVID-Vac
    Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2 infection
    Intervention: Biological: Gam-COVID-Vac
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Biological: 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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 23, 2020)
2000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Written informed consent of a subject to participate in the trial
  2. Males and females aged 18+
  3. Negative HIV, hepatitis, and syphilis test results
  4. A negative test result for the presence of IgM and IgG antibodies to SARS CoV2 by enzyme immunoassay
  5. A negative test result for COVID-2019 by PCR at screening visit
  6. No COVID-2019 in the medical history
  7. No contact with COVID-2019 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 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 medical history.
  9. Donated blood or plasma (450+ ml) within 2 months before the enrollment
  10. Splenectomy in the medical history
  11. 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
  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 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 and other employees directly involved in the trial and their families.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Alexis H García Piñero, MD +582122191711 alexisgarcia27@gmail.com
Contact: Children's Cardiology Hospital "Dr. Gilberto Rodriguez Ochoa" +582122191711 presidencia@espromedbio.gob.ve
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04642339
Other Study ID Numbers  ICMJE 01V-Gam-COVID-Vac-2020
Has Data Monitoring Committee No
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
Plan to Share IPD: No
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 Ministerio del Poder Popular para la Salud de la República Bolivariana de Venezuela
Investigators  ICMJE
Principal Investigator: Alexis H García Piñero, MD Children's Cardiology Hospital "Dr. Gilberto Rodriguez Ochoa"
PRS Account Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Verification Date November 2020

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