A Phase 1/2 Dose-exploration, Randomized, Observer-blind, Placebo-controlled Study to Determine Safety, Tolerance and Immunogenicity of EuCorVac-19, a Recombinant Protein Vaccine, for the Prevention of COVID-19 in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 279
- 试验地点
- 1
- 主要终点
- Immediate AEs
研究概览
简要总结
Phase I/II study to determine safety, tolerance and immunogenicity of EuCorVac-19, a recombinant protein vaccine, for the prevention of COVID-19 in healthy adults
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)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals who voluntarily decide to participate in this study and provide written informed consent
- •Healthy male and female adult at the age of 19 to 50 years (Part A)
- •Healthy male and female adult at the age of 19 to 75 years (Part B)
- •Individuals who are available for all visit procedures including telephone visits during the study period
排除标准
- •COVID-19 positive based on RT-PCR using upper respiratory tract or lower respiratory tract sampling or COVID-19 antibody positive
- •History of SARS-CoV, MERS-CoV or SARS-CoV-2 infection
- •History of vaccination against SARS-CoV, MERS-CoV or SARS-CoV-2
- •Immune system disorders including immunodeficiency disease
- •Clinically significant abnormalities in clinical laboratory test, ECGs and chest X-ray during screening in the opinion of the investigator
- •Fever within 3 days prior to screening or serious acute or chronic infection within 7 days prior to screening requiring systemic antibiotics or antivirals
- •Evidence or history of serious acute, chronic, or progressive disease which, in the opinion of the investigator, makes the individual ineligible for the study
- •History of severe allergic reactions or severe hypersensitivity reactions to the IP or any of its components
- •History of therapy that might affect immunity: treatment with immunosuppresants or immune modifying drugs, anticancer therapy, or radiotherapy within 3 months prior to screening
- •Women of childbearing potential who do not agree to use medically allowed methods of contraception or to be heterosexually inactive until 60 days after the last dose of the IP
- •Pregnant or breastfeeding woman
- •Treatment with other IPs within 6 months prior to participation in this study
- •Other reasons including medical reasons based on which the individual is considered to be ineligible for this study in the opinion of the investigator
研究组 & 干预措施
Phase 1 - EuCorVac-19 Low dose group
Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval
干预措施: Normal Saline (Other)
Phase 1 - EuCorVac-19 High dose group
Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval
干预措施: Normal Saline (Other)
Phase 2 - Placebo comparator group
Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval
干预措施: Normal Saline (Other)
Phase 2 - EuCorVac-19 Low dose group
Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval
干预措施: EuCorVac-19 (Biological)
Phase 1 - EuCorVac-19 High dose group
Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval
干预措施: EuCorVac-19 (Biological)
Phase 2 - EuCorVac-19 High dose group
Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval
干预措施: EuCorVac-19 (Biological)
Phase 1 - EuCorVac-19 Low dose group
Healthy adults received two intramuscular doses (0.5mL per dose) with 3-week interval
干预措施: EuCorVac-19 (Biological)
结局指标
主要结局
Immediate AEs
时间窗: within 30 minutes after each IP dosing
Solicited local and systemic AEs
时间窗: for 7 days after each IP dosing
AESIs
时间窗: within 52 weeks after the last IP dosing
SAEs
时间窗: within 52 weeks after the last IP dosing
Unsolicited AEs
时间窗: within 28 days after the last IP dosing
次要结局
未报告次要终点