Coronavirus InfectionPhase 1/2COVERNCT05037188
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 study testing Low dose BCD-250 injection, High dose BCD-250 injection and Low dose or high dose BCD-250 injection in people with Coronavirus Infection and COVID-19, run by Biocad at 2 sites in Russia.
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) Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Infection, COVID-19
- What is being tested?
- Low dose BCD-250 injection, High dose BCD-250 injection and Low dose or high dose BCD-250 injection
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesRussia
- Study dates
- 10 Aug 2021to 18 Apr 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
UNINOVA clinic
Saint Petersburg
X7 Clinical Research
Saint Petersburg
About this study
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)
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.
- Conditions
- Coronavirus Infection, COVID-19
- Being tested
- Low dose BCD-250 injection, High dose BCD-250 injection, Low dose or high dose BCD-250 injection, Placebo injection
- Keywords
- COVID-19 Vaccine, COVID-19 Virus Disease, COVID-19 Virus Infection, SARS-CoV-2 Infection
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose BCD-250 injectionBiological
A recombinant viral vector AAV5-RBD-S vaccine
High dose BCD-250 injectionBiological
A recombinant viral vector AAV5-RBD-S vaccine
Low dose or high dose BCD-250 injectionBiological
A recombinant viral vector AAV5-RBD-S vaccine
Placebo injectionOther
Placebo injection
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 vaccine candidate (BCD-250) low dose | Experimental | The participants will receive the low dose of BCD-250 Receives: 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 Receives: 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 Receives: Biological: Low dose or high dose BCD-250 injection |
| Cohort 1/Placebo | Placebo comparator | The participants will receive placebo Receives: Other: Placebo injection |
| Cohort 2/COVID-19 vaccine candidate (BCD-250) | Experimental | The participants will receive the selected dose of BCD-250 Receives: Biological: Low dose or high dose BCD-250 injection |
| Cohort 2/Placebo | Placebo comparator | The participants will receive placebo Receives: Other: Placebo injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 56 after the study drug administration
Secondary outcomes (19)
Percentage of subjects with acute immediate hypersensitivity reactions
Percentage of subjects with acute immediate hypersensitivity reactions developed within 30 minutes after study drug administration.
Measured: 30 minutes after the 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.
Measured: 7 days after the 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.
Measured: 7 days after the 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.
Measured: 7 days after the 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.
Measured: 7 days after the 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.
Measured: 56 days after the 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.
Measured: 56 days after the 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
Measured: 56 days after the study drug administration
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
Measured: up to Day 365
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
Measured: Days 7, 14, 21, 28, 56 after the study drug administration.
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
Measured: Days 7, 14, 21, 28, 56 after the study drug administration
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
Measured: Days 7, 14, 21, 28, 56 after the study drug administration
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
Measured: Days 7, 14, 21, 28 after the study drug administration
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
Measured: Days 14, 28, 56 after the study drug administration.
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
Measured: Days 14, 28, 56 after the study drug administration
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
Measured: Days 57- 365
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
Measured: Days 57- 365
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
Measured: Days 57- 365
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
Measured: Days 57- 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start10 Aug 2021
- Primary completion18 Apr 2022
- Study completion18 Apr 2022
Why it stopped: Sponsor's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionStudies of the same condition, open and under way.
- More trials run by BiocadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05037188
- Sponsor's protocol ID
- BCD-250-1
- Acronym
- COVER
- Status last verified
- Jan 2023
- First submitted
- 7 Sep 2021
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05037188
- Acronym / sponsor ID
- COVER / BCD-250-1
- Conditions
- Coronavirus Infection, COVID-19
- Keywords
- COVID-19 Vaccine, COVID-19 Virus Disease, COVID-19 Virus Infection, SARS-CoV-2 Infection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decision
- Enrolment
- 50 participants (actual)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 18 Apr 2022 (actual)
- Study completion
- 18 Apr 2022 (actual)
- First posted
- 8 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- 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.
| Arm | Type | Receives |
|---|---|---|
| COVID-19 vaccine candidate (BCD-250) low dose | Experimental | Biological: Low dose BCD-250 injectionThe participants will receive the low dose of BCD-250 |
| COVID-19 vaccine candidate (BCD-250) high dose | Experimental | Biological: High dose BCD-250 injectionThe participants will receive the high dose of BCD-250 |
| Cohort 1/COVID-19 vaccine candidate (BCD-250) | Experimental | Biological: Low dose or high dose BCD-250 injectionThe participants will receive the selected dose of BCD-250 |
| Cohort 1/Placebo | Placebo comparator | Other: Placebo injectionThe participants will receive placebo |
| Cohort 2/COVID-19 vaccine candidate (BCD-250) | Experimental | Biological: Low dose or high dose BCD-250 injectionThe participants will receive the selected dose of BCD-250 |
| Cohort 2/Placebo | Placebo comparator | Other: Placebo injectionThe participants will receive placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose BCD-250 injectionA recombinant viral vector AAV5-RBD-S vaccine | Biological | COVID-19 vaccine candidate (BCD-250) low dose |
| High dose BCD-250 injectionA recombinant viral vector AAV5-RBD-S vaccine | Biological | COVID-19 vaccine candidate (BCD-250) high dose |
| Low dose or high dose BCD-250 injectionA recombinant viral vector AAV5-RBD-S vaccine | Biological | Cohort 1/COVID-19 vaccine candidate (BCD-250), Cohort 2/COVID-19 vaccine candidate (BCD-250) |
| Placebo injectionPlacebo injection | Other | Cohort 1/Placebo, Cohort 2/Placebo |
Primary outcome
Percentage of subjects with ≥ 4 fold rise of serum SARS-CoV-2-specific IgG titer from baseline
Time frame: Day 56 after the study drug administration
Percentage of subjects with ≥ 4 fold rise of serum SARS-CoV-2-specific IgG titer (binding and neutralizing) from baseline on Day 56
19 secondary outcomes
Percentage of subjects with acute immediate hypersensitivity reactions
Time frame: 30 minutes after the study drug administration
Percentage of subjects with solicited local adverse reactions
Time frame: 7 days after the study drug administration
Percentage of subjects with grade ≥3 solicited local adverse reactions
Time frame: 7 days after the study drug administration
Percentage of subjects with solicited systemic adverse reactions
Time frame: 7 days after the study drug administration
Percentage of subjects with grade ≥3 solicited systemic adverse reactions
Time frame: 7 days after the study drug administration
Percentage of subjects with any adverse reactions
Time frame: 56 days after the study drug administration
Percentage of subjects with any grade ≥3 adverse reactions
Time frame: 56 days after the study drug administration
The proportion of subjects with clinical and laboratory abnormalities
Time frame: 56 days after the study drug administration
Percentage of subjects with adverse events of special interest
Time frame: up to Day 365
Percentage of subjects with SARS-CoV-2-specific IgG antibodies
Time frame: Days 7, 14, 21, 28, 56 after the study drug administration.
Geometric mean titer of SARS-CoV-2-specific IgG antibodies
Time frame: Days 7, 14, 21, 28, 56 after the study drug administration
Change of the SARS-CoV-2-specific IgG antibodies titer from baseline
Time frame: Days 7, 14, 21, 28, 56 after the study drug administration
Percentage of subjects with ≥ 4 fold rise of serum SARS-CoV-2-specific IgG antibodies titer from baseline
Time frame: Days 7, 14, 21, 28 after the study drug administration
Percentage of subjects with detected SARS-CoV-2-specific peripheral blood lymphocytes
Time frame: Days 14, 28, 56 after the study drug administration.
Mean change in SARS-CoV-2-specific peripheral blood lymphocytes count
Time frame: Days 14, 28, 56 after the study drug administration
Percentage of subjects with SARS-CoV-2-specific IgG antibodies
Time frame: Days 57- 365
Geometric mean titer of SARS-CoV-2-specific IgG antibodies
Time frame: Days 57- 365
Change in the SARS-CoV-2-specific IgG titer from baseline
Time frame: Days 57- 365
Percentage of subjects with ≥ 4 fold rise of serum SARS-CoV-2-specific IgG (binding and neutralizing) titer from baseline
Time frame: Days 57- 365
Results and safety
The study was stopped early (reason given: Sponsor's decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Low dose BCD-250 injection, High dose BCD-250 injection and Low dose or high dose BCD-250 injection in people with Coronavirus Infection and COVID-19, run by Biocad at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor's decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects with ≥ 4 fold rise of serum SARS-CoV-2-specific IgG titer from baseline (time frame: Day 56 after the study drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2023.