Clinical Trial of Efficacy, Safety, and Immunogenicity of Gam-COVID-Vac Vaccine Against COVID-19 in Belarus

NCT04564716 | Unknown Phase 3 DMC

• 1 other identifier: 04-Gam-COVID-Vac-2020-RB
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 8

Brief Summary

Randomized, double-blind (blinded for the trial subject and the study physician), placebo controlled, multi-center clinical trial in parallel assignment of efficacy, 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

Keywords

COVID-19; vector vaccine; SARS-CoV-2; adenoviral vector

Outcome Measures

Primary Outcomes (1)

• percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months after the first dose

  Demonstrate the superiority of Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection compared to placebo, based on the percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months after the second dose of the study drug/placebo, as confirmed with the method of polymerase chain reaction (PCR)

  through the whole study, an average of 180 days

Secondary Outcomes (4)

• the severity of the clinical course of COVID-19

  through the whole study, an average of 180 days

• Changing of antibody levels against the SARS-CoV-2 glycoprotein S

  day before injecting the first dose of the study drug/placebo and 42±2 and 180±14 days after the first dose

• Incidence of adverse events in trial subjects

  through the whole study, an average of 180 days

• Severity of adverse events in trial subjects

  through the whole study, an average of 180 days

Study Arms (2)

Primary Group

EXPERIMENTAL

Gam-COVID-Vac combined vector vaccine, 0,5ml/dose+0,5 ml/dose prime-boost immunization in days 1 (component I rAd26-S) and 21(component II rAd5-S)

Biological: Gam-COVID-Vac

Control Group

PLACEBO COMPARATOR

placebo, 0,5ml/dose+0,5 ml/dose immunization in days 1 and 21

Other: Placebo

Interventions

Gam-COVID-Vac BIOLOGICAL

vaccine for intramuscular injection

Primary Group

Placebo OTHER

placebo comparator

Control Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The subject's written informed consent to participate in the study;
• Male and female subjects between the ages of 18 and 60 years (inclusive).
• A negative test result for HIV, hepatitis, syphilis;
• Negative result of research on antibodies IgM and IgG to SARS Cov2 by enzyme-linked immunosorbent assay;
• A negative result of the COVID-2019 study, as determined by the PCR method at the screening visit;
• Lack of COVID-2019 in anamnesis;
• Agreement to use effective contraceptive methods throughout the study period;
• Negative pregnancy test based on the results of a urine test at a screening visit (for women of childbearing age);
• A negative test for the presence of narcotic substances and psycho-stimulating drugs in the urine at the screening visit;
• Negative alcohol test at the screening visit;
• Lack of pre-existing post-vaccination reactions or post-vaccination complications following the use of immunobiological drugs;

You may not qualify if:

• Any vaccination/immunization carried out within 30 days prior to enrollment in the study;
• Female subjects during pregnancy or breastfeeding;
• Tuberculosis, chronic systemic infections;
• The presence of neoplasms in the anamnesis (codes C00-D09);
• Splenectomy in anamnesis;
• Subjects with an active form of disease caused by human immunodeficiency virus, syphilis, hepatitis B and C;
• Anorexia, protein deficiency of any origin;
• Chronic autoimmune diseases or systemic collagenoses in anamnesis
• Extensive tattoos at the injection site (deltoid region) that do not allow for an assessment of the local response to IMP/placebo administration;
• Alcoholism and drug addiction in anamnesis;
• Participation of the subject in any other interventional clinical trial;
• Any other condition of the subject which, in the opinion of the researcher's medical practitioner, may prevent completion of the investigation according to the protocol;
• Staff of research centers and other staff directly involved in the study and their families.

Sponsors & Collaborators

• Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation: lead
• Russian Direct Investment Fund: collaborator
• CRO: iPharma: collaborator

Study Sites (8)

Health Institution "14th Central Regional Polyclinic of the Partisan district of Minsk"

Minsk, Belarus

Location

Health Institution "19th Central Regional Polyclinic of the Pervomaysk district of Minsk"

Minsk, Belarus

Location

Health Institution "1st Central Regional Clinical Polyclinic of the Central district of Minsk"

Minsk, Belarus

Location

Health Institution "28th Regional Polyclinic of Minsk"

Minsk, Belarus

Location

Health Institution "4th City Polyclinic of Minsk"

Minsk, Belarus

Location

Health Institution "5th City Clinical Polyclinic of Minsk"

Minsk, Belarus

Location

Health Institution "Minsk Order of the Red Banner of Labor Regional Clinical Hospital

Minsk, Belarus

Location

Health Institution "Vitebsk Regional Clinical Hospital"

Vitebsk, Belarus

Location

MeSH Terms

Conditions

COVID-19

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

• Roman Plotnikov

  CRO: iPharma

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant, Investigator)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized double-blind placebo-controlled

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: September 25, 2020
• Study Start: September 28, 2020
• Primary Completion: March 28, 2021
• Study Completion: April 10, 2021
• Last Updated: December 2, 2020

Record last verified: 2020-09

Locations

BE (8)