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

NCT04656613 | Unknown Phase 3

• 1 other identifier: 06-Gam-COVID-Vac-2020
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Covid19; SARS-CoV Infection

Keywords

vector; covid-19; adenoviral vector vaccine; Sputnik V

Outcome Measures

Primary Outcomes (5)

• SARS-CoV-2 glycoprotein-specific antibodies titer

  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

  42±4 , 120±14 and 180±14 days

• Seroconversion rate

  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

  42±4, 120±14 and 180±14 days

• IFN-gamma antigen-specific release

  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

  28±4 days

• CD4+/CD8+ proliferating cells

  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

  28±4 days

• Virus-neutralizing antibodies titer

  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

  42±4 and 120±14 days

Secondary Outcomes (1)

• Incidence and severity of adverse events

  within 4 & 6 months

Study Arms (2)

Vaccine

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

a reference group of 250 subjects receiving placebo

Other: placebo

Interventions

Gam-COVID-Vac BIOLOGICAL

the Gam-COVID-Vac is combined 2 -component vector vaccine against the SARS-СoV-2-induced coronavirus infection

Also known as: Sputnik V

Vaccine

placebo OTHER

Placebo Comparator

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Agree to sign the study informed consent form (ICF) before performing any study-specific procedure.
• Adults, i.e., ≥ 18 years old.
• Negative HIV, hepatitis B, hepatitis C, and syphilis test results
• Negative IgM and IgG SARS CoV2 antibodies enzyme immunoassay test result.
• Negative COVID-19 RT-PCR test result at the screening visit.
• No COVID-19 in medical history.
• Subjects to confirm they had no contact with COVID-19 persons within at least 14 days before the screening visit.
• Consent for using effective methods of contraception during the entire trial1
• A negative urine pregnancy test at the screening visit (for child-bearing age women).
• Negative alcohol test at the screening visit.
• No evidence of vaccine-induced reactions or complications after receiving immunobiological products in 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.
• History of COVID-19.
• Positive SARS-CoV-2 screening result obtained by PCR (at screening).
• Test results for IgM and IgG antibodies to SARS-CoV-2 is positive.
• Administration of steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrollment.
• Pregnancy or breast-feeding.
• Acute coronary syndrome or stroke suffered less than one year before the enrollment.
• Tuberculosis, chronic systemic infections in medical history.
• 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.
• Known allergic reactions to vaccination
• History of asthma
• Neoplasms in medical history.
• 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.
• Splenectomy in the past 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.

Sponsors & Collaborators

• Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation: lead
• PDC-CRO: collaborator

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome

Interventions

Gam-COVID-Vac vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mohamed Mostafa

  PDC-CRO

  STUDY DIRECTOR

Central Study Contacts

Mohamed Mostafa

CONTACT

+971555389246; Mohamed.Mostafa@pdc-cro.com

Ahmed Al Hammadi

CONTACT

+971 50 443 3797; Ahhammadi@seha.ae

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 7, 2020
• Study Start: December 1, 2020
• Primary Completion: August 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 7, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share