Randomized, Double-blind, Multicenter Parallel-group Clinical Study of Safety, Tolerability and Immunogenicity of the Betuvax-CoV-2 Recombinant COVID-19 Vaccine, Suspension for Intramuscular Administration in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 116
- 试验地点
- 3
- 主要终点
- Adverse events
研究概览
简要总结
Randomized, double-blind, multicenter parallel-group clinical study of safety, tolerability and immunogenicity of the Betuvax-CoV-2 vaccine. The aim of this study is to investigate the safety, tolerability and immunogenicity of the Betuvax-CoV-2 Recombinant vaccine for the prevention of coronavirus infection caused by the SARS-CoV-2 virus, suspension for intramuscular administration, 10 μg/ml and 40 μg/ml (Ltd. Institute of New Medical Technologies, Russia) in healthy adult volunteers, aged 18 to 60 (inclusive).
详细描述
Participation of the volunteers in the study includes Visit 0 (screening), Visits 1-4 and Visits 10-13 (on an inpatient basis), Visits 5-9 and Visits 14-20 (on an outpatient basis). During Visits 2 and 11, volunteers receive either a study drug (one of two dosages) or a placebo.
The study includes 116 healthy male and female volunteers aged 18 to 60 (inclusive) years who meet the inclusion criteria.
All volunteers are enrolled in two stages of the study and at each stage they are randomized into two or three groups, respectively.
Taking into account the estimated number of volunteers found by the screening results as not meeting the inclusion criteria (54 people), 170 volunteers are screened in the First and Second stage.
The vaccination course includes two intramuscular injections within a 28-day period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The Phase 1 is Open Label; The Phase 2 is double-blind.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group 1 (Phase 1)
All volunteers randomized to Group 1 will be administered the Betuvax-CoV-2 drug according to the following scheme: 20 μg + 5 μg, twice, within a 28-day period.
干预措施: Betuvax-CoV-2 (Biological)
Group 2 (Phase 1)
All volunteers randomized to Group 2 will be administered the Betuvax-CoV-2 drug according to the following scheme: 20 μg + 20 μg, twice, within a 28-day period.
干预措施: Betuvax-CoV-2 (Biological)
Group 3 (Phase 2)
All volunteers randomized to Group 3 will be administered the Betuvax-CoV-2 drug according to the following scheme: 20 μg + 5 μg, twice, within a 28-day period.
干预措施: Betuvax-CoV-2 (Biological)
Group 4 (Phase 2)
All volunteers randomized to Group 4 will be administered the Betuvax-CoV-2 drug according to the following scheme: 20 μg + 20 μg, twice, within a 28-day period.
干预措施: Betuvax-CoV-2 (Biological)
Group 5 (Phase 2)
Volunteers randomized to Group 5 will be administered a placebo reference drug (0.9% aqueous sodium chloride solution), twice, within a 28-day period.
干预措施: Placebo (Drug)
结局指标
主要结局
Adverse events
时间窗: Within 50 days of the first dose of the study drug/placebo
The proportion of the volunteers with any adverse events
Severe adverse events
时间窗: Within 50 days of the first dose of the study drug/placebo
The proportion of the volunteers with severe adverse events
Neutralizing anti-SARS-CoV-2 antibodies
时间窗: 90±5 days after the first administration of the study drug/placebo
The proportion of the volunteers tested positive for the presence of neutralizing anti-SARS-CoV-2 antibodies (SARS-CoV-2 Surrogate Virus Neutralization Test)
Total specific anti-SARS-CoV-2 antibodies
时间窗: 90±5 days after the first administration of the study drug/placebo
The proportion of the volunteers with an increased level of the total specific anti-SARS-CoV-2 antibodies by 4 times or more (ELISA test)
次要结局
- Geometric mean titers of the IgM-specific anti-SARS-CoV-2 antibodies(180±5 days after the first administration of the study drug/placebo)
- Severe or extremely severe course of COVID-19, or lethal outcome(From the 7th day after the second administration of the study drug/placebo till the 180±5 day after the first dose of the study drug/placebo)
- Any adverse events(Within 180±5 days after the first dose of the study drug/placebo)
- IgG-specific anti-SARS-CoV-2 antibodies(180±5 days after the first dose of the study drug/placebo)
- IgM-specific anti-SARS-CoV-2 antibodies(180±5 days after the first dose of the study drug/placebo)
- Neutralizing anti-SARS-CoV-2 antibodies(180±5 days after the first administration of the study drug/placebo)
- Geometric mean titers of the total anti-SARS-CoV-2 antibodies(180±5 days after the first administration of the study drug/placebo)
- Geometric mean titers of the IgG-specific anti-SARS-CoV-2 antibodies(180±5 days after the first administration of the study drug/placebo)
- Specific anti-SARS-CoV-2 cellular immune response (Phase 1)(90±5 days after the first dose of the study drug (only in Phase 1))
- Specific anti-SARS-CoV-2 cellular immune response(180±5 days after the first dose of the study drug/placebo)
- COVID-19 symptoms(From the 7th day after the second administration of the study drug/placebo till the 180±5 day after the first dose of study drug/placebo)
- Moderate, severe or extremely severe course of COVID-19, or lethal outcome(From the 7th day after the second administration of the study drug/placebo till the 180±5 day after the first dose of the study drug/placebo)
- Lethal outcome(From the 7th day after the second administration of the study drug/placebo till the 180±5 day after the first dose of the study drug/placebo)
- Allergic reactions(Within 2 hours of the second study drug/placebo administration)
- Local post-vaccination reactions(Within 7 days after the second administration of the study drug/placebo)
- Systemic post-vaccination reactions(Within 7 days after the second administration of the study drug/placebo)
- Total specific anti-SARS-CoV-2 antibodies(180±5 days after the first administration of the study drug/placebo)
- Severe local post-vaccination reactions(Within 7 days of the second study drug/placebo administration)
- Adverse events of special interest(Within 180±5 days after the first dose of the study drug/placebo)
- Prematurely terminated participation(Within 180±5 days after the administration of the first dose of the study drug/placebo)
- Severe systemic post-vaccination reactions(Within 7 days after the second administration of the study drug/placebo)
- Severe adverse events(Within 180±5 days after the first dose of the study drug/placebo)