Clinical Study of the Safety and Immunogenicity of a Recombinant Viral Vector AAV5 (Adeno-Associated Virus Type 5 )-RBD (Receptor Binding Domain)-S Vaccine for the Prevention of Coronavirus Infection (COVID-19)

Overview

A randomized, double-blind, placebo-controlled, adaptive, seamless phase I / II clinical study of the safety and immunogenicity of a recombinant viral vector AAV5-RBD-S vaccine for the prevention of coronavirus infection (COVID-19)

Full Title of Study: “A Randomized, Double-blind, Placebo-controlled, Adaptive, Seamless Phase I / II Clinical Study of the Safety and Immunogenicity of a Recombinant Viral Vector AAV5-RBD-S Vaccine for the Prevention of Coronavirus Infection (COVID-19)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: April 18, 2022

Detailed Description

The study will be carried out in 2 stages. Stage 1 aims to assess the safety and immunogenicity of different doses of BCD-250 in subjects without a history of COVID-19 infection to choose the optimal dose for further investigation. Stage 2 aims to assess the immunogenicity and safety of the chosen on stage 1 optimal BCD-250 dose compared to placebo in subjects with and without the history of COVID-19 infection.

Interventions

  • Biological: Low dose BCD-250 injection
    • A recombinant viral vector AAV5-RBD-S vaccine
  • Biological: High dose BCD-250 injection
    • A recombinant viral vector AAV5-RBD-S vaccine
  • Biological: Low dose or high dose BCD-250 injection
    • A recombinant viral vector AAV5-RBD-S vaccine
  • Other: Placebo injection
    • Placebo injection

Arms, Groups and Cohorts

  • Experimental: COVID-19 vaccine candidate (BCD-250) low dose
    • The participants will receive the low dose of BCD-250
  • Experimental: COVID-19 vaccine candidate (BCD-250) high dose
    • The participants will receive the high dose of BCD-250
  • Experimental: Cohort 1/COVID-19 vaccine candidate (BCD-250)
    • The participants will receive the selected dose of BCD-250
  • Placebo Comparator: Cohort 1/Placebo
    • The participants will receive placebo
  • Experimental: Cohort 2/COVID-19 vaccine candidate (BCD-250)
    • The participants will receive the selected dose of BCD-250
  • Placebo Comparator: Cohort 2/Placebo
    • The participants will receive placebo

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of subjects with ≥ 4 fold rise of serum SARS-CoV-2-specific IgG titer from baseline
    • Time Frame: Day 56 after the study drug administration
    • Percentage of subjects with ≥ 4 fold rise of serum SARS-CoV-2-specific IgG titer (binding and neutralizing) from baseline on Day 56

Secondary Measures

  • Percentage of subjects with acute immediate hypersensitivity reactions
    • Time Frame: 30 minutes after the study drug administration
    • Percentage of subjects with acute immediate hypersensitivity reactions developed within 30 minutes after study drug administration.
  • Percentage of subjects with solicited local adverse reactions
    • Time Frame: 7 days after the study drug administration
    • Percentage of subjects with local post-vaccination reactions developed within 7 days after study drug administration.
  • Percentage of subjects with grade ≥3 solicited local adverse reactions
    • Time Frame: 7 days after the study drug administration
    • Percentage of subjects with grade ≥3 local post-vaccination reactions developed within 7 days after study drug administration.
  • Percentage of subjects with solicited systemic adverse reactions
    • Time Frame: 7 days after the study drug administration
    • Percentage of subjects with systemic post-vaccination reactions developed within 7 days of study drug administration.
  • Percentage of subjects with grade ≥3 solicited systemic adverse reactions
    • Time Frame: 7 days after the study drug administration
    • Percentage of subjects with grade ≥3 systemic post-vaccination reactions developed within 7 days of study drug administration.
  • Percentage of subjects with any adverse reactions
    • Time Frame: 56 days after the study drug administration
    • Percentage of subjects with any adverse reactions developed within 56 days of study drug administration.
  • Percentage of subjects with any grade ≥3 adverse reactions
    • Time Frame: 56 days after the study drug administration
    • Percentage of subjects with any grade ≥3 adverse reactions developed within 56 days of study drug administration.
  • The proportion of subjects with clinical and laboratory abnormalities
    • Time Frame: 56 days after the study drug administration
    • The proportion of subjects with clinical and laboratory abnormalities developed within 56 days after administration of the study drug
  • Percentage of subjects with adverse events of special interest
    • Time Frame: up to Day 365
    • Adverse events of special interest include the following adverse events: 1) AEs demanding the medical care, 2) Newly developed chronic diseases, 3) serious adverse reactions 4) Laboratory confirmed COVID-19 cases
  • Percentage of subjects with SARS-CoV-2-specific IgG antibodies
    • Time Frame: Days 7, 14, 21, 28, 56 after the study drug administration.
    • Percentage of subjects with SARS-CoV-2-specific IgG (binding and neutralizing) antibodies within the main period of the study
  • Geometric mean titer of SARS-CoV-2-specific IgG antibodies
    • Time Frame: Days 7, 14, 21, 28, 56 after the study drug administration
    • Geometric mean titer of SARS-CoV-2-specific IgG (binding and neutralizing) antibodies within the main period of the study
  • Change of the SARS-CoV-2-specific IgG antibodies titer from baseline
    • Time Frame: Days 7, 14, 21, 28, 56 after the study drug administration
    • Change of the SARS-CoV-2-specific IgG (binding and neutralizing) antibodies titer from baseline within the main period of the study
  • Percentage of subjects with ≥ 4 fold rise of serum SARS-CoV-2-specific IgG antibodies titer from baseline
    • Time Frame: Days 7, 14, 21, 28 after the study drug administration
    • Percentage of subjects with ≥ 4 fold rise of serum SARS-CoV-2-specific IgG (binding and neutralizing) antibodies titer from baseline within the main period of the study
  • Percentage of subjects with detected SARS-CoV-2-specific peripheral blood lymphocytes
    • Time Frame: Days 14, 28, 56 after the study drug administration.
    • Percentage of subjects with detected SARS-CoV-2-specific peripheral blood lymphocytes within the main period of the study
  • Mean change in SARS-CoV-2-specific peripheral blood lymphocytes count
    • Time Frame: Days 14, 28, 56 after the study drug administration
    • Mean change in SARS-CoV-2-specific peripheral blood lymphocytes count within the main period of the study
  • Percentage of subjects with SARS-CoV-2-specific IgG antibodies
    • Time Frame: Days 57- 365
    • Percentage of subjects with SARS-CoV-2-specific IgG (binding and neutralizing) antibodies during the study
  • Geometric mean titer of SARS-CoV-2-specific IgG antibodies
    • Time Frame: Days 57- 365
    • Geometric mean titer of SARS-CoV-2-specific IgG (binding and neutralizing) antibodies during the study
  • Change in the SARS-CoV-2-specific IgG titer from baseline
    • Time Frame: Days 57- 365
    • Change in the SARS-CoV-2-specific IgG (binding and neutralizing) antibodies titer from baseline during the study
  • Percentage of subjects with ≥ 4 fold rise of serum SARS-CoV-2-specific IgG (binding and neutralizing) titer from baseline
    • Time Frame: Days 57- 365
    • Percentage of subjects with ≥ 4 fold rise of serum SARS-CoV-2-specific IgG titer from baseline during the study

Participating in This Clinical Trial

Inclusion Criteria

  • Signed informed consent form – Ability to comply with the study procedures based on the Investigator's assessment – Males and females aged 18-60 years, inclusive, at the date of consent. – Negative pregnancy test (for females of childbearing potential) – Patients of childbearing potential and their partners with preserved reproductive function must agree to use reliable contraceptive methods starting from the time of informed consent for 3 months after Visit 1. This requirement does not apply to patients and their partners who underwent surgical sterilization. Reliable contraceptive methods include one barrier method in combination with one of the following: spermicides, intrauterine device/oral contraceptives. – Cohort 1 only. Negative test for SARS-CoV-2 IgM and IgG at screening – Cohort 2 only. Negative test for SARS-CoV-2 IgM at screening – Cohort 2 only. Confirmed by SARS-CoV-2 RNA test, history of COVID-19 with documented recovery at least 4 month prior consent date. Exclusion Criteria:

  • Positive / uncertain test for SARS-CoV-2 RNA at screening – Cohort 1 only. Documented history of COVID-19. – Changes on chest X-ray suggestive for pneumonia or other lung diseases at screening, excluding clinically non-significant changes in subjects with COVID-19 history on investigator's opinion. – Prior administration of SARS-CoV-2 or other coronavirus vaccine or planning of receiving SARS-CoV-2 or other coronavirus vaccine during the study participation. – Known contact with SARS-CoV-2 infected person or person with known contact with SARS-CoV-2 infected person, within 14 days prior to consent date. – Any acute infectious or non-infectious disease, including convalescence period, less than 4 weeks since clinical recovery – Positive HIV, HBV, HCV or Syphilis tests – History of splenectomy – History of severe allergic reactions – History of allergic or postvaccinal reactions (anaphylactic shock, fever of 40°C or more, fainting, non-febrile convulsions etc.) after vaccine administration – Suspicious hypersensitivity or history of hypersensitivity to any component of investigational product – Participation in other clinical studies within 90 days prior to consent date, excluding screen failures or discontinued prior to the first investigational product administration.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Biocad
  • Provider of Information About this Clinical Study
    • Sponsor

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