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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)

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ClinicalTrials.gov Identifier: NCT05037188
Recruitment Status : Recruiting
First Posted : September 8, 2021
Last Update Posted : September 8, 2021
Sponsor:
Information provided by (Responsible Party):
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)

Condition or disease Intervention/treatment Phase
Coronavirus Infection COVID-19 Biological: Low dose BCD-250 injection Biological: High dose BCD-250 injection Biological: Low dose or high dose BCD-250 injection Other: Placebo injection Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

Stage 1. Subjects without history of COVID-19 infection will be randomized in two treatment groups to receive different doses of BCD-250. After the last subject completes the 28 days of the main study period the safety and immunogenicity analysis will be performed. Based on these results the optimal BCD-250 dose will be selected by the Sponsor considering the Independent Data Monitoring Committee recommendations.

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.

Masking: Double (Participant, Investigator)
Masking Description:

Stage 1 will be open label. The participants will receive the assigned dose of BCD-250 according to the allocation.

Stage 2 will be double blind, placebo-controlled. Investigators and subjects will be unaware of the assigned treatment (BCD-250 or placebo).

Primary Purpose: Prevention
Official Title: 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)
Actual Study Start Date : August 10, 2021
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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


Other Outcome Measures:
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05037188


Contacts
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Contact: Anton Lutckii, MD, PhD +7 (812) 380 49 33 ext 6768 lutskii@biocad.ru

Locations
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Russian Federation
UNINOVA clinic Recruiting
Saint Petersburg, Russian Federation
Contact: Konstantin Zhernakov         
X7 Clinical Research Recruiting
Saint Petersburg, Russian Federation
Contact: Polina Khliabova         
Sponsors and Collaborators
Biocad
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Responsible Party: Biocad
ClinicalTrials.gov Identifier: NCT05037188    
Other Study ID Numbers: BCD-250
First Posted: September 8, 2021    Key Record Dates
Last Update Posted: September 8, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biocad:
COVID-19 Vaccine
COVID-19 Virus Disease
COVID-19 Virus Infection
SARS-CoV-2 Infection
Additional relevant MeSH terms:
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Infections
Communicable Diseases
COVID-19
Coronavirus Infections
Disease Attributes
Pathologic Processes
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases