NCT05037188终止1 期
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)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Biocad
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Percentage of subjects with ≥ 4 fold rise of serum SARS-CoV-2-specific IgG titer from baseline
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
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).
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •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.
排除标准
- •Positive / uncertain test for SARS-CoV-2 RNA at screening
- •Cohort 1 only. Documented history of COVID-
- •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.
结局指标
主要结局
Percentage of subjects with ≥ 4 fold rise of serum SARS-CoV-2-specific IgG titer from baseline
时间窗: 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
次要结局
- Percentage of subjects with acute immediate hypersensitivity reactions(30 minutes after the study drug administration)
- Percentage of subjects with solicited local adverse reactions(7 days after the study drug administration)
- Percentage of subjects with grade ≥3 solicited local adverse reactions(7 days after the study drug administration)
- Percentage of subjects with solicited systemic adverse reactions(7 days after the study drug administration)
- Percentage of subjects with grade ≥3 solicited systemic adverse reactions(7 days after the study drug administration)
- Percentage of subjects with any adverse reactions(56 days after the study drug administration)
- Percentage of subjects with any grade ≥3 adverse reactions(56 days after the study drug administration)
- The proportion of subjects with clinical and laboratory abnormalities(56 days after the study drug administration)
- Percentage of subjects with detected SARS-CoV-2-specific peripheral blood lymphocytes(Days 14, 28, 56 after the study drug administration.)
- Mean change in SARS-CoV-2-specific peripheral blood lymphocytes count(Days 14, 28, 56 after the study drug administration)
- Percentage of subjects with adverse events of special interest(up to Day 365)
- Change of the SARS-CoV-2-specific IgG antibodies titer from baseline(Days 7, 14, 21, 28, 56 after the study drug administration)
- Change in the SARS-CoV-2-specific IgG titer from baseline(Days 57- 365)
- Percentage of subjects with SARS-CoV-2-specific IgG antibodies(Days 57- 365)
- Geometric mean titer of SARS-CoV-2-specific IgG antibodies(Days 57- 365)
- Percentage of subjects with ≥ 4 fold rise of serum SARS-CoV-2-specific IgG antibodies titer from baseline(Days 7, 14, 21, 28 after the study drug administration)
- Percentage of subjects with ≥ 4 fold rise of serum SARS-CoV-2-specific IgG (binding and neutralizing) titer from baseline(Days 57- 365)
研究者
研究点 (2)
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