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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)

Primary Purpose

Coronavirus Infection, COVID-19

Status

Terminated

Phase

Phase 1

Locations

Russian Federation

Study Type

Interventional

Intervention

Low dose BCD-250 injection

High dose BCD-250 injection

Low dose or high dose BCD-250 injection

Placebo injection

About this trial

This is an interventional prevention trial for Coronavirus Infection focused on measuring COVID-19 Vaccine, COVID-19 Virus Disease, COVID-19 Virus Infection, SARS-CoV-2 Infection

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

UNINOVA clinic
X7 Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

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

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

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

Cohort 1/Placebo

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

Cohort 2/Placebo

Arm Description

The participants will receive the low dose of BCD-250

The participants will receive the high dose of BCD-250

The participants will receive the selected dose of BCD-250

The participants will receive placebo

The participants will receive the selected dose of BCD-250

The participants will receive placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of subjects with acute immediate hypersensitivity reactions

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

Percentage of subjects with solicited local adverse reactions

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

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.

Percentage of subjects with solicited systemic adverse reactions

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

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.

Percentage of subjects with any adverse reactions

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

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.

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

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

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

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

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

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

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

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

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

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

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

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

Full Information

NCT ID

NCT05037188

First Posted

September 7, 2021

Last Updated

January 27, 2023

Sponsor

Biocad

1. Study Identification

Unique Protocol Identification Number

NCT05037188

Brief Title

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)

Acronym

COVER

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)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Terminated

Why Stopped

Sponsor's decision

Study Start Date

August 10, 2021 (Actual)

Primary Completion Date

April 18, 2022 (Actual)

Study Completion Date

April 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biocad

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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)

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronavirus Infection, COVID-19

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Sequential Assignment

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

ParticipantInvestigator

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).

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

The participants will receive the low dose of BCD-250

Arm Title

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

Arm Type

Experimental

Arm Description

The participants will receive the high dose of BCD-250

Arm Title

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

Arm Type

Experimental

Arm Description

The participants will receive the selected dose of BCD-250

Arm Title

Cohort 1/Placebo

Arm Type

Placebo Comparator

Arm Description

The participants will receive placebo

Arm Title

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

Arm Type

Experimental

Arm Description

The participants will receive the selected dose of BCD-250

Arm Title

Cohort 2/Placebo

Arm Type

Placebo Comparator

Arm Description

The participants will receive placebo

Intervention Type

Biological

Intervention Name(s)

Low dose BCD-250 injection

Intervention Description

A recombinant viral vector AAV5-RBD-S vaccine

Intervention Type

Biological

Intervention Name(s)

High dose BCD-250 injection

Intervention Description

A recombinant viral vector AAV5-RBD-S vaccine

Intervention Type

Biological

Intervention Name(s)

Low dose or high dose BCD-250 injection

Intervention Description

A recombinant viral vector AAV5-RBD-S vaccine

Intervention Type

Other

Intervention Name(s)

Placebo injection

Intervention Description

Placebo injection

Primary Outcome Measure Information:

Title

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

Description

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 Outcome Measure Information:

Title

Percentage of subjects with acute immediate hypersensitivity reactions

Description

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

Title

Percentage of subjects with solicited local adverse reactions

Description

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

Title

Percentage of subjects with grade ≥3 solicited local adverse reactions

Description

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

Title

Percentage of subjects with solicited systemic adverse reactions

Description

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

Title

Percentage of subjects with grade ≥3 solicited systemic adverse reactions

Description

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

Title

Percentage of subjects with any adverse reactions

Description

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

Time Frame

56 days after the study drug administration

Title

Percentage of subjects with any grade ≥3 adverse reactions

Description

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

Title

The proportion of subjects with clinical and laboratory abnormalities

Description

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

Title

Percentage of subjects with adverse events of special interest

Description

Time Frame

up to Day 365

Title

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

Description

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.

Title

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

Description

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

Title

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

Description

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

Title

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

Description

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

Title

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

Description

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.

Title

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

Description

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

Title

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

Description

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

Time Frame

Days 57- 365

Title

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

Description

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

Time Frame

Days 57- 365

Title

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

Description

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

Time Frame

Days 57- 365

Title

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

Description

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 Pre-specified Outcome Measures:

Title

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

Description

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

Time Frame

up to Day 365

Title

Percentage of subjects with AAV5-specific IgG antibodies

Description

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

Time Frame

up to Day 365

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

UNINOVA clinic

City

Saint Petersburg

Country

Russian Federation

Facility Name

X7 Clinical Research

City

Saint Petersburg

Country

Russian Federation

12. IPD Sharing Statement

Plan to Share IPD

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