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TerminatedNCT05037188COVERUpdated Jan 30, 2023

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)

A Phase 1/2 interventional study of Low dose BCD-250 injection and High dose BCD-250 injection in Coronavirus Infection and COVID-19, sponsored by Biocad. Terminated at 2 sites in Russian Federation. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-30.

Sponsored by Biocad · Phase 1/2, Interventional, and Prevention

Why this study was terminated
Sponsor's decision
Phase
Phase 1/2
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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)

Read the 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.

02

Conditions studied

  • Coronavirus Infection
  • COVID-19

Keywords

  • COVID-19 Vaccine
  • COVID-19 Virus Disease
  • COVID-19 Virus Infection
  • SARS-CoV-2 Infection
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 50 is below the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Biocad is the lead sponsor of 94 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
50 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • Placebo comparator
    Cohort 1/Placebo

    The participants will receive placebo

    Other: 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

  • Placebo comparator
    Cohort 2/Placebo

    The participants will receive placebo

    Other: Placebo injection

Interventions

  • BiologicalLow dose BCD-250 injection

    A recombinant viral vector AAV5-RBD-S vaccine

  • BiologicalHigh dose BCD-250 injection

    A recombinant viral vector AAV5-RBD-S vaccine

  • BiologicalLow dose or high dose BCD-250 injection

    A recombinant viral vector AAV5-RBD-S vaccine

  • OtherPlacebo injection

    Placebo injection

06

What researchers measure

Primary outcomes

  1. Percentage of subjects with ≥ 4 fold rise of serum SARS-CoV-2-specific IgG titer from baseline

    Percentage of subjects with ≥ 4 fold rise of serum SARS-CoV-2-specific IgG titer (binding and neutralizing) from baseline on Day 56

    Time frame: Day 56 after the study drug administration

Secondary outcomes

  1. Percentage of subjects with acute immediate hypersensitivity reactions

    Percentage of subjects with acute immediate hypersensitivity reactions developed within 30 minutes after study drug administration.

    Time frame: 30 minutes after the study drug administration

  2. Percentage of subjects with solicited local adverse reactions

    Percentage of subjects with local post-vaccination reactions developed within 7 days after study drug administration.

    Time frame: 7 days after the study drug administration

  3. Percentage of subjects with grade ≥3 solicited local adverse reactions

    Percentage of subjects with grade ≥3 local post-vaccination reactions developed within 7 days after study drug administration.

    Time frame: 7 days after the study drug administration

  4. Percentage of subjects with solicited systemic adverse reactions

    Percentage of subjects with systemic post-vaccination reactions developed within 7 days of study drug administration.

    Time frame: 7 days after the study drug administration

  5. Percentage of subjects with grade ≥3 solicited systemic adverse reactions

    Percentage of subjects with grade ≥3 systemic post-vaccination reactions developed within 7 days of study drug administration.

    Time frame: 7 days after the study drug administration

  6. Percentage of subjects with any adverse reactions

    Percentage of subjects with any adverse reactions developed within 56 days of study drug administration.

    Time frame: 56 days after the study drug administration

  7. Percentage of subjects with any grade ≥3 adverse reactions

    Percentage of subjects with any grade ≥3 adverse reactions developed within 56 days of study drug administration.

    Time frame: 56 days after the study drug administration

  8. The proportion of subjects with clinical and laboratory abnormalities

    The proportion of subjects with clinical and laboratory abnormalities developed within 56 days after administration of the study drug

    Time frame: 56 days after the study drug administration

  9. Percentage of subjects with adverse events of special interest

    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

    Time frame: up to Day 365

  10. Percentage of subjects with SARS-CoV-2-specific IgG antibodies

    Percentage of subjects with SARS-CoV-2-specific IgG (binding and neutralizing) antibodies within the main period of the study

    Time frame: Days 7, 14, 21, 28, 56 after the study drug administration.

  11. Geometric mean titer of SARS-CoV-2-specific IgG antibodies

    Geometric mean titer of SARS-CoV-2-specific IgG (binding and neutralizing) antibodies within the main period of the study

    Time frame: Days 7, 14, 21, 28, 56 after the study drug administration

  12. Change of the SARS-CoV-2-specific IgG antibodies titer from baseline

    Change of the SARS-CoV-2-specific IgG (binding and neutralizing) antibodies titer from baseline within the main period of the study

    Time frame: Days 7, 14, 21, 28, 56 after the study drug administration

  13. Percentage of subjects with ≥ 4 fold rise of serum SARS-CoV-2-specific IgG antibodies titer from baseline

    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

    Time frame: Days 7, 14, 21, 28 after the study drug administration

  14. Percentage of subjects with detected SARS-CoV-2-specific peripheral blood lymphocytes

    Percentage of subjects with detected SARS-CoV-2-specific peripheral blood lymphocytes within the main period of the study

    Time frame: Days 14, 28, 56 after the study drug administration.

  15. Mean change in SARS-CoV-2-specific peripheral blood lymphocytes count

    Mean change in SARS-CoV-2-specific peripheral blood lymphocytes count within the main period of the study

    Time frame: Days 14, 28, 56 after the study drug administration

  16. Percentage of subjects with SARS-CoV-2-specific IgG antibodies

    Percentage of subjects with SARS-CoV-2-specific IgG (binding and neutralizing) antibodies during the study

    Time frame: Days 57- 365

  17. Geometric mean titer of SARS-CoV-2-specific IgG antibodies

    Geometric mean titer of SARS-CoV-2-specific IgG (binding and neutralizing) antibodies during the study

    Time frame: Days 57- 365

  18. Change in the SARS-CoV-2-specific IgG titer from baseline

    Change in the SARS-CoV-2-specific IgG (binding and neutralizing) antibodies titer from baseline during the study

    Time frame: Days 57- 365

  19. Percentage of subjects with ≥ 4 fold rise of serum SARS-CoV-2-specific IgG (binding and neutralizing) titer from baseline

    Percentage of subjects with ≥ 4 fold rise of serum SARS-CoV-2-specific IgG titer from baseline during the study

    Time frame: Days 57- 365

Other outcomes

  1. The proportion of subjects with identified AAV5 in biological fluids (blood, saliva and urine)

    The proportion of subjects with identified AAV5 in biological fluids (blood, saliva and urine) during the study

    Time frame: up to Day 365

  2. Percentage of subjects with AAV5-specific IgG antibodies

    Percentage of subjects with AAV5-specific IgG antibodies during the study

    Time frame: up to Day 365

07

Study locations

2 sites
  • UNINOVA clinic
    Saint Petersburg, Russian Federation
  • X7 Clinical Research
    Saint Petersburg, Russian Federation
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05037188
Lead sponsor
Biocad
Responsible party
Sponsor
First posted
Sep 8, 2021
Start date
Aug 10, 2021
Primary completion
Apr 18, 2022
Completion
Apr 18, 2022
Last update
Jan 30, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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