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)
NCT ID: NCT05037188
Last Updated: 2023-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2021-08-10
2022-04-18
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
Stage 2. Subjects without history of COVID-19 infection (Cohort 1) and with history of COVID-19 infection (Cohort 2) will be randomized to receive either selected dose of BCD-250 or placebo.
PREVENTION
DOUBLE
Stage 2 will be double blind, placebo-controlled. Investigators and subjects will be unaware of the assigned treatment (BCD-250 or placebo).
Study Groups
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COVID-19 vaccine candidate (BCD-250) low dose
The participants will receive the low dose of BCD-250
Low dose BCD-250 injection
A recombinant viral vector AAV5-RBD-S vaccine
COVID-19 vaccine candidate (BCD-250) high dose
The participants will receive the high dose of BCD-250
High dose BCD-250 injection
A recombinant viral vector AAV5-RBD-S vaccine
Cohort 1/COVID-19 vaccine candidate (BCD-250)
The participants will receive the selected dose of BCD-250
Low dose or high dose BCD-250 injection
A recombinant viral vector AAV5-RBD-S vaccine
Cohort 1/Placebo
The participants will receive placebo
Placebo injection
Placebo injection
Cohort 2/COVID-19 vaccine candidate (BCD-250)
The participants will receive the selected dose of BCD-250
Low dose or high dose BCD-250 injection
A recombinant viral vector AAV5-RBD-S vaccine
Cohort 2/Placebo
The participants will receive placebo
Placebo injection
Placebo injection
Interventions
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Low dose BCD-250 injection
A recombinant viral vector AAV5-RBD-S vaccine
High dose BCD-250 injection
A recombinant viral vector AAV5-RBD-S vaccine
Low dose or high dose BCD-250 injection
A recombinant viral vector AAV5-RBD-S vaccine
Placebo injection
Placebo injection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
60 Years
ALL
Yes
Sponsors
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Biocad
INDUSTRY
Responsible Party
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Locations
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UNINOVA clinic
Saint Petersburg, , Russia
X7 Clinical Research
Saint Petersburg, , Russia
Countries
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Other Identifiers
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BCD-250-1
Identifier Type: -
Identifier Source: org_study_id
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