NCT04821674已完成1 期
A Phase 1/2 Study to Assess the Safety, Immunogenicity and Recommended Dose of DS-5670a (COVID-19 Vaccine) in Japanese Healthy Adults and Elderly Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Number of Participants Reporting Local and Systemic Adverse Events
研究概览
简要总结
This study will assess the safety, tolerability and immunogenicity of DS-5670a (COVID-19 Vaccine) and determine the recommended dose in Japanese healthy adults and elderly participants.
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)
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Japanese citizen
- •Healthy adults aged ≥20 and <65 years, or healthy elderly aged ≥65 and <75 years (at the time of informed consent)
- •Body Mass Index (BMI) is ≥17.5 and <30.0 kg/m^2 (at screening)
- •Participants who can follow the compliance requirements during clinical trials, undergo medical examinations and tests specified by the protocol, and report symptoms, etc.
排除标准
- •Have a history of immunodeficiency or having a close relative with congenital immunodeficiency.
- •Have a history of SARS-CoV-2 infection.
- •Have previously participated in an investigational study of SARS-Cov-2 vaccine or involving LNPs.
- •Have a history of anaphylaxis or severe allergies due to food, cosmetics, medicines, or vaccination
- •Have alcohol or drug dependence.
- •Have a fever of ≥39.0°C or symptoms of suspected allergies such as systemic rash within 2 days after past vaccination, etc.
结局指标
主要结局
Number of Participants Reporting Local and Systemic Adverse Events
时间窗: Day 1 up to Day 14 post-first and second dose
Seroconversion Rates of SARS-CoV-2 Specific Neutralizing Antibody
时间窗: Days 15, 29, 43, and 57 post-dose
Number of Participants Reporting Serious Events
时间窗: Day 1 up to 12 months post-second dose
Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody
时间窗: Days 15, 29, 43, and 57 post-dose
Number of Participants Reporting Treatment-emergent Adverse Events
时间窗: Day 1 up to Day 57 post-dose
Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific Neutralizing Antibody
时间窗: Days 15, 29, 43, and 57 post-dose
次要结局
- Seroconversion Rates of anti-IgG Antibody(Days 15, 29, 43, and 57 post-dose)
- Pharmacokinetic Parameter of Area Under the Concentration-time Curve Following Intramuscular Injection of DS-5670a(Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose)
- Pharmacokinetic Parameter of Terminal Elimination Half-life (t1/2) Following Intramuscular Injection of DS-5670a(Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose)
- Pharmacokinetic Parameter of Apparent Volume of Distribution (Vz/F) Following Intramuscular Injection of DS-5670a(Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose)
- GMFR of anti-IgG Antibody(Days 15, 29, 43, and 57 post-dose)
- Pharmacokinetic Parameter of Apparent Total Body Clearance (CL/F) Following Intramuscular Injection of DS-5670a(Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose)
- Pharmacokinetic Parameter of Maximum (Peak) Observed Plasma Concentration (Cmax) Following Intramuscular Injection of DS-5670a(Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose)
- GMT of anti-IgG Antibody(Days 15, 29, 43, and 57 post-dose)
- Pharmacokinetic Parameter of Time to Reach Maximum Concentration (Tmax) Following Intramuscular Injection of DS-5670a(Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose)
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
1 期
A Study to Determine Safety and Immunogenicity of the Candidate COVID-19 Vaccine AZD1222 Delivered by Aerosol in Healthy Adult VolunteersCovid19SARS-CoV-2 InfectionNCT05007275Imperial College London28
Unknown
1 期
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of SARS-CoV-2 Variant (COVID-19 Omicron) mRNA Vaccine (Phase 1)COVID-19NCT05433194Suzhou Abogen Biosciences Co., Ltd.48
已完成
1 期
Safety and Immunogenicity Study of a H5N1 Influenza Vaccine (Vero Cell-Derived, Whole Virus) in Healthy Infants, Children and AdolescentsInfluenza, AvianNCT01052402Resilience Government Services, Inc.684
已完成
1 期
Phase I Clinical Trial of GEN2-Recombinant COVID-19 Vaccine (CHO Cells) in Healthy People Aged 18 and AboveCOVID-19 PneumoniaNCT05408312National Vaccine and Serum Institute, China234
终止
1 期
Safety and Immunogenicity Study of GX-19, a COVID-19 Preventive DNA Vaccine in Healthy AdultsSARS-CoV-2NCT04445389Genexine, Inc.60