Clinical Trial of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Against COVID-19

NCT04540419 | Completed Phase 3

• 1 other identifier: Prometheus_Rus
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 7

Brief Summary

This study is a phase III clinical trial to evaluate efficacy, reactogenicity and safety of the vaccine Ad5-nCoV compared with placebo in volunteers at the age from 18 to 85 years，with the randomized, double-blind design

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Superiority of the vaccine Ad5-nCoV to placebo by the level of seroconversion

  Proportion of subjects with four-fold and higher increment of anti-receptor-binding domain antibodies \[receptor-binding domain, RBD\] of S-protein SARS-CoV-2).

  Day 28 after vaccination

Secondary Outcomes (32)

• Immunogenicity of the vaccine Ad5-nCoV compared with placebo (titer of SARS-CoV-2 antibodies)

  Day 14, 28 and after 6 months after vaccination.

• Immunogenicity of the vaccine Ad5-nCoV compared with placebo (level of seroconversion)

  Day 14, 28 and after 6 months after vaccination.

• Immunogenicity of the vaccine Ad5-nCoV compared with placebo (rise of SARS-CoV-2 antibodies)

  Day 14, 28 and after 6 months after vaccination.

• Immunogenicity of the vaccine Ad5-nCoV compared with placebo (T-cell response)

  Day 14, 28 and after 6 months after vaccination.

• Frequency of confirmed COVID-19

  Within 6 months after vaccination (except for COVID-19 cases within 14 days after vaccination)

Study Arms (2)

Ad5-nCoV single dose

EXPERIMENTAL

375 subjects, Ad5-nCoV containing 5E10 vp, single dose

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

Placebo single dose

PLACEBO COMPARATOR

125 subjects, Placebo containing 0 vp, single dose

Biological: Placebo

Interventions

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) BIOLOGICAL

Intramuscular administration

Ad5-nCoV single dose

Placebo BIOLOGICAL

Intramuscular administration

Placebo single dose

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of signed and dated Informed Consent of volunteer for participation in this study.
• Men and women at the age of 18-85 years.
• Bodyweight index 18.5-30.0 kg/m2.
• The negative result of the test, performed by using PCR, for the presence of SARS-CoV-2 RNA at the stage of screening.
• Negative result for anti-SARS-CoV-2 IgM and IgG antibodies at the stage of screening.
• No history of the diagnosis COVID-19.
• Absence of close contacts with individuals, suspicious for infection SARS-CoV-2, or individuals, in whom the diagnosis COVID-19 was confirmed in laboratory within the last 14 days.
• Absence of signs of respiratory infection within the last 14 days.
• Negative results of human immunodeficiency virus (HIV), syphilis, hepatitis B and hepatitis C tests.
• According to historical data and results of screening examination, a volunteer has no diseases and/or conditions, which in view of Investigator, may influence the safety of volunteer participation and evaluation of study results.
• Volunteer consent for using safe contraceptive methods through all the study.

You may not qualify if:

• Positive history of allergy, drug intolerance, including increased sensibility to any of components of the test drug product, as well as the history of serious adverse events in the administration of vaccines (such as allergic reactions, respiratory disturbance, angioedema, stomach pain).
• Axillary body temperature ≥37.1 °C at the time of screening/randomization.
• Systolic blood pressure more than 139 mm Hg or less than 100 mm Hg and/or diastolic blood pressure more than 90 mm Hg or less than 60 mm Hg.
• Clinical significant abnormal laboratory and/or instrumental parameters at screening examination.
• Acute infectious diseases less than 4 weeks ahead of conduction of screening procedures.
• Acute and acute course of chronic diseases of GIT, liver, kidneys, cardiovascular, respiratory, nervous and endocrine systems.
• History of blood and hematopoietic organ diseases.
• History of diabetes mellitus.
• History of epilepsy, epileptic syndrome, seizures.
• History of congenital and acquired immunodeficiency, HIV-infection, lymphoma, leukaemia, systemic lupus erythematosus, juvenile rheumatoid arthritis or other autoimmune diseases.
• History malignancies.
• Using immunotropic preparations (immunomodulators, immunostimulators, immunodepressants), antiallergic, cytotoxic preparations for more than 10 sequential days within the last 3 months (except for inhalant and local using glucocorticoids \[GCS\] or using specified preparations less than 4 weeks ahead of the screening.
• Using immunoglobulin preparations or blood transfusion less than 3 months ahead of the screening.
• Using antipyretics (including non-steroidal anti-inflammatory agents and anilides) within 24 hours ahead of randomization.
• Blood donation or loss (≥450 mL of blood or plasma) less than 3 months ahead of the screening.

Sponsors & Collaborators

• NPO Petrovax: lead
• CanSino Biologics Inc.: collaborator

Study Sites (7)

Federal budgetary institution of science "Central Research Institute of Epidemiology" of the Federal Service for Surveillance on Consumer Rights Protectionand Human Welfare

Moscow, 111123, Russia

Location

State Budgetary Institution of Healthcare of the City of Moscow "City Polyclinic No. 2of the Department of Healthcare of the City of Moscow"

Moscow, 117556, Russia

Location

Federal State Autonomous Educational Institution of Higher Education "First MoscowState Medical University named after I.M. Sechenov "of the Ministry of Health of the Russian Federation

Moscow, 119991, Russia

Location

Limited Liability Company "Research Center Eco-safety"

Saint Petersburg, 196143, Russia

Location

Federal State Budgetary Institution "Research Institute of Influenza named after A.A.Smorodintsev "of the Ministry of Health of the Russian Federation

Saint Petersburg, 197376, Russia

Location

Private health care institution "Clinical hospital 'Russian Railways - Medicine' of the city of Yaroslavl"

Yaroslavl, 150030, Russia

Location

Municipal budgetary institution "Central City Hospital No. 7"

Yekaterinburg, 620137, Russia

Location

Related Publications (1)

• Lioznov D, Amosova I, Sheetikov SA, Zornikova KV, Serdyuk Y, Efimov GA, Tsyferov M, Khmelevskii M, Afanasiev A, Khomyakova N, Zubkov D, Tikhonov A, Zhu T, Barreto L, Dzutseva V. Immunogenicity and safety of a recombinant adenovirus type-5 COVID-19 vaccine in adults: Data from a randomised, double-blind, placebo-controlled, single-dose, phase 3 trial in Russia. PLoS One. 2023 Mar 8;18(3):e0278878. doi: 10.1371/journal.pone.0278878. eCollection 2023.

  PMID: 36888640 DERIVED

MeSH Terms

Conditions

COVID-19

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 Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: September 7, 2020
• Study Start: September 11, 2020
• Primary Completion: June 19, 2021
• Study Completion: July 30, 2021
• Last Updated: April 23, 2024

Record last verified: 2024-04

Locations

RU (7)