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

NCT04530396 | Unknown Phase 3 DMC

• 1 other identifier: 04-Gam-COVID-Vac-2020
• Study Type: interventional
• Target: 33,758
• Locations: 1 country
• Sites: 23

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 Prevention

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 (7)

• 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

• Changing of antigen-specific cellular immunity level

  the drug administration day before injecting the first dose of the study drug/placebo and 28±2 days after the first dose

• Changing of of virus neutralizing antibody titer

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

• Incidence 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 - 111 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent of a subject to participate in the trial
• Males and females aged ≥18 y.o.;
• Negative HIV, hepatitis, and syphilis test results
• Negative anti-SARS CoV2 IgM and IgG antibodies test carried out with the enzyme immunoassay method
• Negative COVID-2019 PCR test result at the screening visit
• No COVID-2019 in the past medical history
• No contact with COVID-2019 diseased persons within at least 14 days before the enrollment (according to trial subjects)
• Consent to use effective contraception methods during the trial
• Negative urine pregnancy test at the screening visit (for child-bearing age women)
• Negative drugs or psychostimulants urine test at the screening visit
• Negative alcohol test at the screening visit
• No evident vaccine-induced reactions or complications after receiving immunobiological products in the past 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;
• Steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrollment
• Immunosuppressors therapy finished within 3 months before the enrollment
• Pregnancy or breast-feeding
• Acute coronary syndrome or stroke suffered less than one year before the enrollment
• Tuberculosis, chronic systemic infections
• 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
• Neoplasms in the past medical history (ICD codes C00-D09)
• Donated blood or plasma (450+ ml) within 2 months before the enrollment
• History of splenectomy;
• Neutropenia (absolute neutrophil count \<1,000/mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin \<80 g/L), immunodeficiency in the past medical history within 6 months before the enrollment
• Active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis B or C
• Anorexia, protein deficiency of any origin
• Big-size tattoos at the injection site (deltoid muscle area), which does not allow assessing the local response to the study drug/placebo administration
• Alcohol or drug addiction in the past medical history

Sponsors & Collaborators

• Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation: lead
• Government of the city of Moscow: collaborator
• CRO: Crocus Medical BV: collaborator

Study Sites (23)

ARCHIMED V Clinic of new medical technologies limited liability company

Moscow, Russia

Location

Hadassah LTD

Moscow, Russia

Location

Medsi Group of companies joint-stock company"

Moscow, Russia

Location

Niarmedic Plus

Moscow, Russia

Location

State budgetary healthcare institution of the city of Moscow "City clinical hospital No. 52 of the Moscow city health Department"

Moscow, Russia

Location

State Budgetary Healthcare Institution, Moscow, Consultation and Diagnosis Polyclinic No. 121, Moscow Healthcare Department

Moscow, Russia

Location

State Budgetary Healthcare Institution, Moscow, M. Konchalovsky Municipal Clinical Hospital, Moscow Healthcare Department

Moscow, Russia

Location

State Budgetary Healthcare Institution, Moscow, M. Zhadkevich Municipal Clinical Hospital, Moscow Healthcare Department

Moscow, Russia

Location

State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 115, Moscow Healthcare Department

Moscow, Russia

Location

State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 2, Moscow Healthcare Department

Moscow, Russia

Location

State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 210, Moscow Healthcare Department

Moscow, Russia

Location

State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 212, Moscow Healthcare Department

Moscow, Russia

Location

State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 219, Moscow Healthcare Department

Moscow, Russia

Location

State Budgetary Healthcare Institution, Moscow, Municipal Polyclinic No. 220, Moscow Healthcare Department

Moscow, Russia

Location

State Budgetary Healthcare Institution, Municipal Polyclinic No. 62, Moscow Healthcare Department

Moscow, Russia

Location

State budgetary institution of health care of the city of Moscow " city polyclinic No. 109 Of the Department of health of the city of Moscow"

Moscow, Russia

Location

State budgetary institution of health care of the city of Moscow " city polyclinic No. 170 Of the Department of health of the city of Moscow"

Moscow, Russia

Location

State budgetary institution of health care of the city of Moscow " city polyclinic No. 36 Of the Department of health of the city of Moscow"

Moscow, Russia

Location

State budgetary institution of health care of the city of Moscow " city polyclinic No. 46 Of the Department of health of the city of Moscow"

Moscow, Russia

Location

State budgetary institution of health care of the city of Moscow " city polyclinic No. 6 Of the Department of health of the city of Moscow"

Moscow, Russia

Location

State budgetary institution of health care of the city of Moscow " city polyclinic No. 68 Of the Department of health of the city of Moscow"

Moscow, Russia

Location

State budgetary institution of health care of the city of Moscow "Diagnostic center No. 5 with polyclinic Department Of the Department of health of the city of Moscow"

Moscow, Russia

Location

State budgetary institution of health care of the city of Moscow "Diagnostic clinical center No. 1 Of the Department of health of the city of Moscow"

Moscow, Russia

Location

Related Publications (1)

• Logunov DY, Dolzhikova IV, Shcheblyakov DV, Tukhvatulin AI, Zubkova OV, Dzharullaeva AS, Kovyrshina AV, Lubenets NL, Grousova DM, Erokhova AS, Botikov AG, Izhaeva FM, Popova O, Ozharovskaya TA, Esmagambetov IB, Favorskaya IA, Zrelkin DI, Voronina DV, Shcherbinin DN, Semikhin AS, Simakova YV, Tokarskaya EA, Egorova DA, Shmarov MM, Nikitenko NA, Gushchin VA, Smolyarchuk EA, Zyryanov SK, Borisevich SV, Naroditsky BS, Gintsburg AL; Gam-COVID-Vac Vaccine Trial Group. Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia. Lancet. 2021 Feb 20;397(10275):671-681. doi: 10.1016/S0140-6736(21)00234-8. Epub 2021 Feb 2.

  PMID: 33545094 DERIVED

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

• Elena Smolyarchuk, MD, PhD

  Study Coordinator

  STUDY CHAIR

• Sergey Zyryanov, MD, PhD

  Study Coordinator

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: 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: August 25, 2020
• First Posted: August 28, 2020
• Study Start: September 7, 2020
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: January 22, 2021

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (23)