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) (COVER)

January 27, 2023 updated by: Biocad

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)

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Saint Petersburg, Russian Federation
        • UNINOVA clinic
      • Saint Petersburg, Russian Federation
        • X7 Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: COVID-19 vaccine candidate (BCD-250) low dose
The participants will receive the low dose of BCD-250
Biological: Low dose BCD-250 injection
A recombinant viral vector AAV5-RBD-S vaccine
Experimental: COVID-19 vaccine candidate (BCD-250) high dose
The participants will receive the high dose of BCD-250
Biological: High dose BCD-250 injection
A recombinant viral vector AAV5-RBD-S vaccine
Experimental: Cohort 1/COVID-19 vaccine candidate (BCD-250)
The participants will receive the selected dose of BCD-250
Biological: Low dose or high dose BCD-250 injection
A recombinant viral vector AAV5-RBD-S vaccine
Placebo Comparator: Cohort 1/Placebo
The participants will receive placebo
Other: Placebo injection
Placebo injection
Experimental: Cohort 2/COVID-19 vaccine candidate (BCD-250)
The participants will receive the selected dose of BCD-250
Biological: Low dose or high dose BCD-250 injection
A recombinant viral vector AAV5-RBD-S vaccine
Placebo Comparator: Cohort 2/Placebo
The participants will receive placebo
Other: Placebo injection
Placebo injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Day 56 after the study drug administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
30 minutes after the 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.
7 days after the 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.
7 days after the 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.
7 days after the 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.
7 days after the 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.
56 days after the 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.
56 days after the 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
56 days after the study drug administration
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
up to Day 365
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
Days 7, 14, 21, 28, 56 after the study drug administration.
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
Days 7, 14, 21, 28, 56 after the study drug administration
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
Days 7, 14, 21, 28, 56 after the study drug administration
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
Days 7, 14, 21, 28 after the study drug administration
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
Days 14, 28, 56 after the study drug administration.
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
Days 14, 28, 56 after the study drug administration
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
Days 57- 365
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
Days 57- 365
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
Days 57- 365
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
Days 57- 365

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The proportion of subjects with identified AAV5 in biological fluids (blood, saliva and urine)
Time Frame: up to Day 365
The proportion of subjects with identified AAV5 in biological fluids (blood, saliva and urine) during the study
up to Day 365
Percentage of subjects with AAV5-specific IgG antibodies
Time Frame: up to Day 365
Percentage of subjects with AAV5-specific IgG antibodies during the study
up to Day 365

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biocad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 10, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 18, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 18, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2021

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BCD-250-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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