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)

NCT05037188 | Terminated Phase 1 DMC

• 1 other identifier: BCD-250-1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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)

Conditions

Coronavirus Infection; COVID-19

Keywords

COVID-19 Vaccine; COVID-19 Virus Disease; COVID-19 Virus Infection; SARS-CoV-2 Infection

Outcome Measures

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

  Day 56 after the study drug administration

Secondary Outcomes (19)

• Percentage of subjects with acute immediate hypersensitivity reactions

  30 minutes after the study drug administration

• Percentage of subjects with solicited local adverse reactions

  7 days after the study drug administration

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

  7 days after the study drug administration

• Percentage of subjects with solicited systemic adverse reactions

  7 days after the study drug administration

• Percentage of subjects with grade ≥3 solicited systemic adverse reactions

  7 days after the study drug administration

Other Outcomes (2)

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

  up to Day 365

• Percentage of subjects with AAV5-specific IgG antibodies

  up to Day 365

Study Arms (6)

COVID-19 vaccine candidate (BCD-250) low dose

EXPERIMENTAL

The participants will receive the low dose of BCD-250

Biological: Low dose BCD-250 injection

COVID-19 vaccine candidate (BCD-250) high dose

EXPERIMENTAL

The participants will receive the high dose of BCD-250

Biological: High dose BCD-250 injection

Cohort 1/COVID-19 vaccine candidate (BCD-250)

EXPERIMENTAL

The participants will receive the selected dose of BCD-250

Biological: Low dose or high dose BCD-250 injection

Cohort 1/Placebo

PLACEBO COMPARATOR

The participants will receive placebo

Other: Placebo injection

Cohort 2/COVID-19 vaccine candidate (BCD-250)

EXPERIMENTAL

The participants will receive the selected dose of BCD-250

Biological: Low dose or high dose BCD-250 injection

Cohort 2/Placebo

PLACEBO COMPARATOR

The participants will receive placebo

Other: Placebo injection

Interventions

Low dose BCD-250 injection BIOLOGICAL

A recombinant viral vector AAV5-RBD-S vaccine

COVID-19 vaccine candidate (BCD-250) low dose

High dose BCD-250 injection BIOLOGICAL

A recombinant viral vector AAV5-RBD-S vaccine

COVID-19 vaccine candidate (BCD-250) high dose

Low dose or high dose BCD-250 injection BIOLOGICAL

A recombinant viral vector AAV5-RBD-S vaccine

Cohort 1/COVID-19 vaccine candidate (BCD-250); Cohort 2/COVID-19 vaccine candidate (BCD-250)

Placebo injection OTHER

Placebo injection

Cohort 1/Placebo; Cohort 2/Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biocad: lead

Study Sites (2)

UNINOVA clinic

Saint Petersburg, Russia

Location

X7 Clinical Research

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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).
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 8, 2021
• Study Start: August 10, 2021
• Primary Completion: April 18, 2022
• Study Completion: April 18, 2022
• Last Updated: January 30, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2)