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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)

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ClinicalTrials.gov Identifier: NCT04656613
Recruitment Status : 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

Tracking Information
First Submitted Date  ICMJE November 30, 2020
First Posted Date  ICMJE December 7, 2020
Last Update Posted Date December 7, 2020
Estimated Study Start Date  ICMJE December 2020
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2020)
  • 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
  • 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
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2020)
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.
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 A Phase III Clinical Trial of the Immunogenicity and Safety of the Gam-COVID-Vac Vaccine Against COVID-19 in the UAE
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Condition  ICMJE
  • Covid19
  • SARS-CoV Infection
Intervention  ICMJE
  • 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
  • Other: placebo
    Placebo Comparator
Study Arms  ICMJE
  • Experimental: Vaccine
    a study group of 750 subjects receiving the Gam-COVID-Vac combined vector vaccine against the SARS-СoV-2-induced coronavirus infection
    Intervention: Biological: Gam-COVID-Vac
  • Placebo Comparator: Placebo
    a reference group of 250 subjects receiving placebo
    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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 4, 2020)
1000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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: Mohamed Mostafa +971555389246 Mohamed.Mostafa@pdc-cro.com
Contact: Ahmed Al Hammadi +971 50 443 3797 Ahhammadi@seha.ae
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04656613
Other Study ID Numbers  ICMJE 06-Gam-COVID-Vac-2020
Has Data Monitoring Committee Not Provided
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 PDC-CRO
Investigators  ICMJE
Study Director: Mohamed Mostafa PDC-CRO
PRS Account Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Verification Date December 2020

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