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)

COVID-19 Clinical Trial

— 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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05037188
• Other study ID #: BCD-250-1
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: August 10, 2021
• Est. completion date: April 18, 2022

Study information

• Verified date: January 2023
• Source: Biocad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: April 18, 2022
• Est. primary completion date: April 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Coronavirus Infection
• Coronavirus Infections
• COVID-19
• Infections

Intervention

Biological:
• Low dose BCD-250 injection
A recombinant viral vector AAV5-RBD-S vaccine
• High dose BCD-250 injection
A recombinant viral vector AAV5-RBD-S vaccine
• Low dose or high dose BCD-250 injection
A recombinant viral vector AAV5-RBD-S vaccine

Other:
• Placebo injection
Placebo injection

Locations

Country	Name	City	State
Russian Federation	UNINOVA clinic	Saint Petersburg
Russian Federation	X7 Clinical Research	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Biocad

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	up to Day 365
Other	Percentage of subjects with AAV5-specific IgG antibodies	Percentage of subjects with AAV5-specific IgG antibodies during the study	up to Day 365
Primary	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	Percentage of subjects with acute immediate hypersensitivity reactions	Percentage of subjects with acute immediate hypersensitivity reactions developed within 30 minutes after study drug administration.	30 minutes after the study drug administration
Secondary	Percentage of subjects with solicited local adverse reactions	Percentage of subjects with local post-vaccination reactions developed within 7 days after study drug administration.	7 days after the study drug administration
Secondary	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.	7 days after the study drug administration
Secondary	Percentage of subjects with solicited systemic adverse reactions	Percentage of subjects with systemic post-vaccination reactions developed within 7 days of study drug administration.	7 days after the study drug administration
Secondary	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.	7 days after the study drug administration
Secondary	Percentage of subjects with any adverse reactions	Percentage of subjects with any adverse reactions developed within 56 days of study drug administration.	56 days after the study drug administration
Secondary	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.	56 days after the study drug administration
Secondary	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	56 days after the study drug administration
Secondary	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	up to Day 365
Secondary	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	Days 7, 14, 21, 28, 56 after the study drug administration.
Secondary	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	Days 7, 14, 21, 28, 56 after the study drug administration
Secondary	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	Days 7, 14, 21, 28, 56 after the study drug administration
Secondary	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	Days 7, 14, 21, 28 after the study drug administration
Secondary	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	Days 14, 28, 56 after the study drug administration.
Secondary	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	Days 14, 28, 56 after the study drug administration
Secondary	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	Days 57- 365
Secondary	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	Days 57- 365
Secondary	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	Days 57- 365
Secondary	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	Days 57- 365