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)

Biocad2 sites in 1 country50 target enrollmentAugust 10, 2021

ConditionsCoronavirus Infection COVID-19

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Coronavirus Infection
Sponsor: Biocad
Enrollment: 50
Locations: 2
Primary Endpoint: Percentage of subjects with ≥ 4 fold rise of serum SARS-CoV-2-specific IgG titer from baseline
Status: Terminated
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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)

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.

Registry

clinicaltrials.gov

Start Date

August 10, 2021

End Date

April 18, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Biocad

Responsible Party

Sponsor

Eligibility Criteria

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
•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-
•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

Outcomes

Primary Outcomes

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 Outcomes

Percentage of subjects with acute immediate hypersensitivity reactions(30 minutes after the study drug administration)
Percentage of subjects with solicited local adverse reactions(7 days after the study drug administration)
Percentage of subjects with grade ≥3 solicited local adverse reactions(7 days after the study drug administration)
Percentage of subjects with solicited systemic adverse reactions(7 days after the study drug administration)
Percentage of subjects with grade ≥3 solicited systemic adverse reactions(7 days after the study drug administration)
Percentage of subjects with any adverse reactions(56 days after the study drug administration)
Percentage of subjects with any grade ≥3 adverse reactions(56 days after the study drug administration)
The proportion of subjects with clinical and laboratory abnormalities(56 days after the study drug administration)
Percentage of subjects with detected SARS-CoV-2-specific peripheral blood lymphocytes(Days 14, 28, 56 after the study drug administration.)
Mean change in SARS-CoV-2-specific peripheral blood lymphocytes count(Days 14, 28, 56 after the study drug administration)
Percentage of subjects with adverse events of special interest(up to Day 365)
Change of the SARS-CoV-2-specific IgG antibodies titer from baseline(Days 7, 14, 21, 28, 56 after the study drug administration)
Change in the SARS-CoV-2-specific IgG titer from baseline(Days 57- 365)
Percentage of subjects with SARS-CoV-2-specific IgG antibodies(Days 57- 365)
Geometric mean titer of SARS-CoV-2-specific IgG antibodies(Days 57- 365)
Percentage of subjects with ≥ 4 fold rise of serum SARS-CoV-2-specific IgG antibodies titer from baseline(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) titer from baseline(Days 57- 365)