Clinical trial NCT05037188: 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)
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
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Coronavirus Infection
COVID-19
Keywords: COVID-19 Vaccine
COVID-19 Virus Disease
COVID-19 Virus Infection
SARS-CoV-2 Infection
Lead sponsor: Biocad
Sponsor class: INDUSTRY
First posted: 2021-09-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Percentage of subjects with ≥ 4 fold rise of serum SARS-CoV-2-specific IgG titer from baseline
timeFrame: Day 56 after the study drug administration
Secondary outcomes:
measure: Percentage of subjects with acute immediate hypersensitivity reactions
timeFrame: 30 minutes after the study drug administration
measure: Percentage of subjects with solicited local adverse reactions
timeFrame: 7 days after the study drug administration
measure: Percentage of subjects with grade ≥3 solicited local adverse reactions
timeFrame: 7 days after the study drug administration
measure: Percentage of subjects with solicited systemic adverse reactions
timeFrame: 7 days after the study drug administration
measure: Percentage of subjects with grade ≥3 solicited systemic adverse reactions
timeFrame: 7 days after the study drug administration
measure: Percentage of subjects with any adverse reactions
timeFrame: 56 days after the study drug administration
measure: Percentage of subjects with any grade ≥3 adverse reactions
timeFrame: 56 days after the study drug administration
measure: The proportion of subjects with clinical and laboratory abnormalities
timeFrame: 56 days after the study drug administration
measure: Percentage of subjects with adverse events of special interest
timeFrame: up to Day 365
measure: Percentage of subjects with SARS-CoV-2-specific IgG antibodies
timeFrame: Days 7, 14, 21, 28, 56 after the study drug administration.
measure: Geometric mean titer of SARS-CoV-2-specific IgG antibodies
timeFrame: Days 7, 14, 21, 28, 56 after the study drug administration
measure: Change of the SARS-CoV-2-specific IgG antibodies titer from baseline
timeFrame: Days 7, 14, 21, 28, 56 after the study drug administration
measure: Percentage of subjects with ≥ 4 fold rise of serum SARS-CoV-2-specific IgG antibodies titer from baseline
timeFrame: Days 7, 14, 21, 28 after the study drug administration
measure: Percentage of subjects with detected SARS-CoV-2-specific peripheral blood lymphocytes
timeFrame: Days 14, 28, 56 after the study drug administration.
measure: Mean change in SARS-CoV-2-specific peripheral blood lymphocytes count
timeFrame: Days 14, 28, 56 after the study drug administration
measure: Percentage of subjects with SARS-CoV-2-specific IgG antibodies
timeFrame: Days 57- 365
measure: Geometric mean titer of SARS-CoV-2-specific IgG antibodies
timeFrame: Days 57- 365
measure: Change in the SARS-CoV-2-specific IgG titer from baseline
timeFrame: Days 57- 365
measure: Percentage of subjects with ≥ 4 fold rise of serum SARS-CoV-2-specific IgG (binding and neutralizing) titer from baseline
timeFrame: Days 57- 365
Other outcomes:
measure: The proportion of subjects with identified AAV5 in biological fluids (blood, saliva and urine)
timeFrame: up to Day 365
measure: Percentage of subjects with AAV5-specific IgG antibodies
timeFrame: up to Day 365
Locations:
city: Saint Petersburg
country: Russian Federation
facility: UNINOVA clinic
city: Saint Petersburg
country: Russian Federation
facility: X7 Clinical Research
Study officials:
References: