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A Phase III Clinical Trial of the Immunogenicity and Safety of the Gam-COVID-Vac Vaccine Against COVID-19 in the UAE (SPUTNIK-UAE)

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: NCT04656613
Recruitment Status : Unknown
Verified December 2020 by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation.
Recruitment status was:  Not yet recruiting
First Posted : December 7, 2020
Last Update Posted : December 7, 2020
Sponsor:
Collaborator:
PDC-CRO
Information provided by (Responsible Party):
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Study Description
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Brief Summary:
This study is randomized, double-blind (blinded for the trial subject and the study physician), placebo-controlled trial in the parallel assignment of the 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 SARS-CoV Infection Biological: Gam-COVID-Vac Other: placebo Phase 3

Detailed Description:

The subjects will be randomized into two groups in the ratio of 1:3; a reference group of 250 subjects receiving placebo and a study group of 750 subjects 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. Each subject will participate in the trial for 180±14 days after the first dose of the study vaccine/placebo and will have in total six on-site visits to the study physician during the study period and several follow-ups Phone Call/ Teleconsultation during the study as follow:

  • One Screening visit, i.e., Screening Visit = Day -7 to Day -1

  • Two vaccination visits, i.e.,

    o Visit 1 / Day1

  • Tele-consultation / Phone Call to start on Day 2 and a weekly basis until visit 2

    o Visit 2/ Day 21±2 Days

  • Tele-consultation / Phone Call to occur on Day 22±2 Days then on a weekly basis until visit 3.
  • Four Observational Visits to be scheduled as follow:
  • Visit 3/ Day 28 ±2 days
  • Weekly Follow Up Tele-consultation / Phone calls until visit 4
  • Visit 4/ Day 42 ±4 days
  • Weekly Follow Up Tele-consultation / Phone Call until visit 5
  • Visit 5/ Day 90 ±7 days
  • Weekly Follow Up Tele-consultation / Phone Call until visit 6
  • Visit 6/ Day 120 ±14 days
  • Weekly Follow Up Tele-consultation / Phone calls until visit 7
  • End of Study Visit/ Visit 7/ Day 180 ± 14 days The study vaccine/placebo will be administered intramuscularly during vaccination visits 1 and 2 (day 1 and day 21±2). Subsequent observation visits 3, 4, 5, 6 and end of study visit / EOS /Visit 7 will be made on days 28±2, 42±4, 90±7, 120±14 and D180±14 respectively. During the observation visits, vitals will be assessed in all trial subjects, and changes in the subjects' condition and wellbeing compared to the previous visit will be recorded. Blood samples will be collected per the schedule of assessment from all subjects during the following visits to assess the following immunogenicity parameters.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: A Phase III, Randomized, Double -Blind, Placebo-controlled Trial to Evaluate Immunogenicity and Safety of the Gam-COVID-Vac Combined Vector Vaccine in Prophylactic Treatment for SARS-СoV-2 Infection in the United Arab Emirates
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Vaccine
a study group of 750 subjects receiving the Gam-COVID-Vac combined vector vaccine against the SARS-СoV-2-induced coronavirus infection
 Biological: Gam-COVID-Vac
the Gam-COVID-Vac is combined 2 -component vector vaccine against the SARS-СoV-2-induced coronavirus infection
Other Name: Sputnik V
Placebo Comparator: Placebo
a reference group of 250 subjects receiving placebo
 Other: placebo
Placebo Comparator


Outcome Measures
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Primary Outcome Measures :
  1. SARS-CoV-2 glycoprotein-specific antibodies titer [ Time Frame: 42±4 , 120±14 and 180±14 days ]
    The geometric mean titer of the SARS-CoV-2 glycoprotein-specific antibodies in trial subjects on the drug administration day before injecting the first dose of the study vaccine/placebo and 42±4 , 120±14 and 180±14 days after the first dose

  2. Seroconversion rate [ Time Frame: 42±4, 120±14 and 180±14 days ]
    Percentage of trial subjects with fourfold or more increase in the titer of SARS-CoV-2 glycoprotein-specific antibodies in trial subjects on the drug administration day before injecting the first dose of the study vaccine/placebo and 42±4, 120±14 and 180±14 days after the first dose

  3. IFN-gamma antigen-specific release [ Time Frame: 28±4 days ]
    Interferon gamma concentration in response to S protein after re-stimulation with the SARS-CoV-2 glycoprotein in trial subjects on the drug administration day before injecting the first dose of the study vaccine/placebo and 28±4 days after the first dose

  4. CD4+/CD8+ proliferating cells [ Time Frame: 28±4 days ]
    The number of proliferating CD4 and CD8 cells in response to antigen stimulation in trial subjects on the drug administration day before injecting the first dose of the study vaccine/placebo and 28±4 days after the first dose

  5. Virus-neutralizing antibodies titer [ Time Frame: 42±4 and 120±14 days ]
    Geometric mean virus-neutralizing antibodies titer in trial subjects on the drug administration day before injecting the first dose of the study vaccine/placebo and 42±4 and 120±14 days after the first dose


Secondary Outcome Measures :
  1. Incidence and severity of adverse events [ Time Frame: within 4 & 6 months ]
    Incidence and severity of adverse events in trial subjects within 4 & 6 months after injecting the first dose of the study vaccine/placebo.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Agree to sign the study informed consent form (ICF) before performing any study-specific procedure.
  2. Adults, i.e., ≥ 18 years old.
  3. Negative HIV, hepatitis B, hepatitis C, and syphilis test results
  4. Negative IgM and IgG SARS CoV2 antibodies enzyme immunoassay test result.
  5. Negative COVID-19 RT-PCR test result at the screening visit.
  6. No COVID-19 in medical history.
  7. Subjects to confirm they had no contact with COVID-19 persons within at least 14 days before the screening visit.
  8. Consent for using effective methods of contraception during the entire trial1
  9. A negative urine pregnancy test at the screening visit (for child-bearing age women).
  10. Negative alcohol test at the screening visit.
  11. No evidence of vaccine-induced reactions or complications after receiving immunobiological products in medical history.
  12. 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. History of COVID-19.
  3. Positive SARS-CoV-2 screening result obtained by PCR (at screening).
  4. Test results for IgM and IgG antibodies to SARS-CoV-2 is positive.
  5. Administration of steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrollment.
  6. Pregnancy or breast-feeding.
  7. Acute coronary syndrome or stroke suffered less than one year before the enrollment.
  8. Tuberculosis, chronic systemic infections in medical history.
  9. 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 vaccine components, acute exacerbation of allergic diseases on the enrollment day.
  10. Known allergic reactions to vaccination
  11. History of asthma
  12. Neoplasms in medical history.
  13. Major operations in the past 12 months before study vaccine administration. This will include but not limited to; major organs transplant, bone marrow donation, etc.
  14. Splenectomy in the past medical history
  15. 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.
  16. Any family member with immunodeficiency, cancer, or transplantation
  17. The active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis B, or C.
  18. Subjects with diabetes, heart disease, chronic kidney disease, or dialysis
  19. Subjects with latent tuberculosis infection
  20. Anorexia, protein deficiency of any origin.
  21. Subjects with any metabolic diseases
  22. Tattoos or scars at the injection site (deltoid muscle area), which in the medical opinion of the investigator does not allow assessing the local response to the study vaccine/placebo administration.
  23. Alcohol or drug addiction in medical history.
  24. Participation in any other interventional clinical trial within the previous 90 days (from the administration of the Vaccine).
  25. Any other condition that the study physician considers as a barrier to the trial completion as per the protocol.
  26. Healthcare workers
Contacts and Locations
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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): NCT04656613


Contacts
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Contact: Mohamed Mostafa +971555389246 Mohamed.Mostafa@pdc-cro.com
Contact: Ahmed Al Hammadi +971 50 443 3797 Ahhammadi@seha.ae

Sponsors and Collaborators
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
PDC-CRO
Investigators
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Study Director: Mohamed Mostafa PDC-CRO
More Information
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Responsible Party: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
ClinicalTrials.gov Identifier: NCT04656613    
Other Study ID Numbers: 06-Gam-COVID-Vac-2020
First Posted: December 7, 2020    Key Record Dates
Last Update Posted: December 7, 2020
Last Verified: December 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:
vector
covid-19
adenoviral vector vaccine
Sputnik V
Additional relevant MeSH terms:
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Infections
COVID-19
Severe Acute Respiratory Syndrome
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases