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Sponsor's decision
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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID-19 vaccine candidate (BCD-250) low dose | Experimental | The participants will receive the low dose of BCD-250 |
|
| COVID-19 vaccine candidate (BCD-250) high dose | Experimental | The participants will receive the high dose of BCD-250 |
|
| Cohort 1/COVID-19 vaccine candidate (BCD-250) | Experimental | The participants will receive the selected dose of BCD-250 |
|
| Cohort 1/Placebo | Placebo Comparator | The participants will receive placebo |
|
| Cohort 2/COVID-19 vaccine candidate (BCD-250) | Experimental | The participants will receive the selected dose of BCD-250 |
|
| Cohort 2/Placebo | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose BCD-250 injection | Biological | A recombinant viral vector AAV5-RBD-S vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Percentage of subjects with solicited local adverse reactions |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Percentage of subjects with AAV5-specific IgG antibodies |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNINOVA clinic | Saint Petersburg | Russia | ||||
| X7 Clinical Research |
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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.
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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).
The participants will receive placebo |
|
| High dose BCD-250 injection | Biological | A recombinant viral vector AAV5-RBD-S vaccine |
|
| Low dose or high dose BCD-250 injection | Biological | A recombinant viral vector AAV5-RBD-S vaccine |
|
| Placebo injection | Other | Placebo injection |
|
Percentage of subjects with local post-vaccination reactions developed within 7 days after study drug administration. |
| 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Days 57- 365 |
Percentage of subjects with AAV5-specific IgG antibodies during the study |
| up to Day 365 |
| Saint Petersburg |
| Russia |
| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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