Randomized, Observer-Blind, Placebo-Controlled, Phase 2/3 Study to Assess the Safety, Efficacy, and Immunogenicity of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine in Adults 18 Years of Age or Older
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30,918
- 试验地点
- 85
- 主要终点
- Phase 2 portion: Percentage of subjects with normal and abnormal clinically significant urine values
研究概览
简要总结
This Phase 2/3 study is a multi-portion design to confirm that the chosen formulation and dosing regimen of CoVLP has an acceptable immunogenicity and safety profile.
The Phase 3 portion is an event-driven, randomized, observer blinded, placebo-controlled design that will evaluate the efficacy and safety of the CoVLP formulation compared to placebo.
Subjects will be followed for safety and immunogenicity for a period of 12 months after the last vaccination.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Observer-blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older 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
Placebo
Placebo (0.5 mL)
干预措施: Intramuscular injection (Drug)
3.75 µg of CoVLP Vaccine adjuvanted
3.75 µg of CoVLP adjuvanted vaccine with AS03 adjuvant (0.5 mL)
干预措施: Intramuscular vaccine (Biological)
结局指标
主要结局
Phase 2 portion: Percentage of subjects with normal and abnormal clinically significant urine values
时间窗: 3 days
Percentage of subjects with normal and abnormal clinically significant urine values
Phase 3 portion: Laboratory-confirmed (virologic method) symptomatic SARS-CoV-2 infection
时间窗: Day 28 and after
First occurrence, in a subject, of laboratory-confirmed (virologic method) symptomatic SARS-CoV-2 infection
Phase 2 portion: Number of subjects with normal and abnormal clinically significant urine values
时间窗: 3 days
Number of subjects with normal and abnormal clinically significant urine values
Phase 2 portion: Immediate adverse event (AEs)
时间窗: 30 minutes
Percentage, intensity, and relationship to vaccination of immediate AEs
Phase 2 portion: Unsolicited adverse events (AEs)
时间窗: 21 days
Percentage, intensity, and relationship of unsolicited AEs
Phase 2 portion: Number of subjects with normal and abnormal clinically significant haematological values
时间窗: 3 days
Number of subjects with normal and abnormal clinically significant haematological values
Phase 2 portion: Serious adverse events (SAEs), adverse events (AEs) leading to withdrawal, adverse event of special interest (AESI) (including vaccine-enhanced disease) and deaths
时间窗: 21 days
Percentage of SAEs, MAAEs, AEs leading to withdrawal, AESIs (including VED), and deaths
Phase 2 portion: Neutralizing antibody (Nab assay) response
时间窗: Day 42
Nab response induced in each Study Population against the SARS-CoV-2 virus
Phase 2 portion:Specific Th1 cell-mediated immunity (CMI) response
时间窗: Day 42
Specific Th1 CMI response induced in each Study Population against the SARS-CoV-2 , as measured by IFN-γ ELISpot
Phase 2 portion: Solicited local and systemic adverse events (AEs)
时间窗: 7 days
Percentage, intensity, and relationship to vaccination of solicited local and systemic AEs
Phase 2 portion: Number of subjects with normal and abnormal clinically significant biochemical values
时间窗: 3 days
Number of subjects with normal and abnormal clinically significant biochemical values
Phase 2 portion: Percentage of subjects with normal and abnormal clinically significant haematological values
时间窗: 3 days
Percentage of subjects with normal and abnormal clinically significant haematological values
Phase 2 portion: Percentage of subjects with normal and abnormal clinically biochemical values
时间窗: 3 days
Percentage of subjects with normal and abnormal clinically biochemical values
次要结局
- Phase 2 portion: Specific Th2 cell-mediated immunity (CMI) response(Day 386)
- Phase 2 portion: Neutralizing antibody Geometric mean tiers (GMT) response (populations 1 and 2)(21 days)
- Phase 2 portion: Specific antibody (IgG) response(Day 386)
- Phase 2 portion: Neutralizing antibody titers: IgG ELISA antibody titers(Day 386)
- Phase 2 portion: Solicited local and systemic AEs (populations 1 and 2)(7 days)
- Phase 2 portion: Neutralizing antibody Geometric mean tiers (GMT) response (populations 1, 2 and 3)(21 days)
- Phase 2 portion: Specific Th1 cell-mediated immunity (CMI) response(Day 386)
- Phase 3 portion: Neutralizing antibody Geometric mean titers (GMT) response(Day 386)
- Phase 3 portion: Neutralizing antibody Geometric mean titers (GMT)(Day 201)
- Phase 3 portion: Immediate adverse event (AEs)(30 minutes)
- Phase 3 portion: Unsolicited adverse events (AEs)(21 days)
- Phase 3 portion: Serious adverse events (SAEs), adverse events (AEs) leading to withdrawal, adverse event of special interest (AESI) (including vaccine-enhanced disease) and deaths(Day 0 to 386)
- Phase 2 portion: Neutralizing antibody (Nab assay) response(Day 386)
- Phase 3 portion: Specific antibody (IgG) response(Day 386)
- Phase 2 portion: Laboratory-confirmed (virologic method) symptomatic SARS-CoV-2 infection(Day 28 to 386)
- Phase 2 portion: Severe COVID-19 disease(Day 28 to 386)
- Phase 2 portion: Solicited local and systemic AEs (populations 1, 2 and 3)(7 days)
- Phase 2 portion: Serious adverse events (SAEs), medically attended adverse events (MAAEs), adverse events (AEs) leading to withdrawal, adverse event of special interest (AESI) (including vaccine-enhanced disease) and deaths(Day 43 to 386)
- Phase 3 portion: Solicited local and systemic AEs(7 days)
- Phase 3 portion: Neutralizing antibody Geometric mean fold rise (GMFR) response(Day 386)
- Phase 3 portion: Neutralizing antibody titers: IgG ELISA antibody titers(Day 386)
- Phase 3 portion: Neutralizing antibody Seroconversion (SC) rate response(Day 386)
- Phase 3 portion: Laboratory-confirmed symptomatic SARS-CoV-2 infection (by strain)(through efficacy analysis, approximately 4 months)
- Phase 3 portion: Specific Th1 cell-mediated immunity (CMI) response(Day 386)
- Phase 3 portion: Specific Th2 cell-mediated immunity (CMI) response(Day 386)
- Phase 3 portion: COVID-19-related symptoms in virologically-confirmed cases(through efficacy analysis, approximately 4 months)
- Phase 3 portion: Severe COVID-19 disease(Day 28 to 386)
- Phase 3 portion: Viral shedding after SARS-CoV-2 infection(through efficacy analysis, approximately 4 months)
- Phase 3 portion: Laboratory-confirmed asymptomatic SARS-CoV-2 infection(Day 201)
- Phase 3 portion: Laboratory-confirmed symptomatic SARS-CoV-2 infection(Day 21 to 28)