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)

Phase 1

Terminated

• Conditions: COVID-19; Coronavirus Infection
• Interventions: Biological: High dose BCD-250 injection; Biological: Low dose or high dose BCD-250 injection; Other: Placebo injection; Biological: Low dose BCD-250 injection

• Registration Number: NCT05037188
• Lead Sponsor: Biocad

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.

Study Timeline

• Study Start: 2021-08-10
• Study First Submitted: 2021-09-07
• Study First Submitted QC: 2021-09-07
• Study First Posted: 2021-09-08
• Primary Completion: 2022-04-18
• Study Completion: 2022-04-18
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-27
• Last Update Posted: 2023-01-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
COVID-19 vaccine candidate (BCD-250) high dose	High dose BCD-250 injection	The participants will receive the high dose of BCD-250
Cohort 2/COVID-19 vaccine candidate (BCD-250)	Low dose or high dose BCD-250 injection	The participants will receive the selected dose of BCD-250
Cohort 1/COVID-19 vaccine candidate (BCD-250)	Low dose or high dose BCD-250 injection	The participants will receive the selected dose of BCD-250
Cohort 1/Placebo	Placebo injection	The participants will receive placebo
Cohort 2/Placebo	Placebo injection	The participants will receive placebo
COVID-19 vaccine candidate (BCD-250) low dose	Low dose BCD-250 injection	The participants will receive the low dose of BCD-250

Primary Outcome Measures

Name	Time	Method
Percentage of subjects with ≥ 4 fold rise of serum SARS-CoV-2-specific IgG titer from baseline	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 Outcome Measures

Name	Time	Method
The proportion of subjects with clinical and laboratory abnormalities	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 solicited local adverse reactions	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	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	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	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	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 detected SARS-CoV-2-specific peripheral blood lymphocytes	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	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 adverse events of special interest	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
Change of the SARS-CoV-2-specific IgG antibodies titer from baseline	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
Change in the SARS-CoV-2-specific IgG titer from baseline	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 SARS-CoV-2-specific IgG antibodies	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	Days 57- 365	Geometric mean titer of SARS-CoV-2-specific IgG (binding and neutralizing) antibodies during the study
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) 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 (binding and neutralizing) titer from baseline	Days 57- 365	Percentage of subjects with ≥ 4 fold rise of serum SARS-CoV-2-specific IgG titer from baseline during the study
Percentage of subjects with any grade ≥3 adverse reactions	56 days after the study drug administration	Percentage of subjects with any grade ≥3 adverse reactions developed within 56 days of study drug administration.
Percentage of subjects with acute immediate hypersensitivity reactions	30 minutes after the study drug administration	Percentage of subjects with acute immediate hypersensitivity reactions developed within 30 minutes after study drug administration.

Trial Locations

Locations (2)

UNINOVA clinic; 🇷🇺 Saint Petersburg, Russian Federation

X7 Clinical Research; 🇷🇺 Saint Petersburg, Russian Federation