Phase 1, Placebo-controlled, Randomized, Observer-blind, First-in-human Study of Bivalent RSV Prefusion F Protein Vaccines (SCB-1019/SCB-1019T) in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Evaluate the reactogenicity of SCB-1019, SCB-1019T compared with AREXVY vaccine
研究概览
简要总结
First-in-human Safety and Immunogenicity Study of SCB-1019 and SCB-1019T in Healthy Adults
详细描述
A Phase 1, placebo-controlled, randomized, observer-blind, First-in-human Study to describe the Safety, reactogenicity and immunogenicity of a bivalent recombinant RSV vaccines (SCB-1019 and SCB-1019T) 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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female participants 60 to 85 years of age at the screening visit.
- •Individuals willing and able to comply with study requirements, including all scheduled visits, vaccination, laboratory tests, and other study procedures.
- •Individuals willing and able to give an informed consent, prior to screening. Healthy participants as determined by medical history, physical examination, and clinical judgment of the investigator; participants with pre-existing stable medical conditions can be included.
排除标准
- •Acute disease or fever (≥38°C) at time of vaccination.
- •History of a severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccines.
- •Any progressive unstable or uncontrolled clinical conditions.
- •Any progressive or severe neurologic disorder, seizure disorder, or history of Guillain-Barré syndrome.
- •Please refer to Protocol for full list of Inclusion and Exclusion criteria.
研究组 & 干预措施
group 7 (Placebo; older adults)
4 older adults (60-85 years old) will receive Placebo at Day 1
干预措施: placebo (Biological)
group 1 (SCB-1019 low dose with Alum; young adults)
4 young adults (18-59 years old) will receive SCB-1019 (Low Dose with Alum) at Day 1
干预措施: Candidate vaccine, SCB-1019 (Biological)
group 2 (Placebo; young adults)
2 young adults (18-59 years old) will receive Placebo at Day 1
干预措施: placebo (Biological)
group 3 (SCB-1019 high dose with Alum; Young Adults)
4 young adults (18-59 years old) will receive SCB-1019 (high dose with Alum) at Day 1
干预措施: Candidate vaccine, SCB-1019 (Biological)
group 4 (Placebo; young adults)
2 young adults (18-59 years old) will receive Placebo at Day 1
干预措施: placebo (Biological)
group 5 (SCB-1019 low dose without Alum; older adults)
10 older adults (60-85 years old) will receive SCB-1019 (low dose without Alum) at Day 1
干预措施: Candidate vaccine, SCB-1019 (Biological)
group 6 (SCB-1019 low dose with Alum; older adults)
10 older adults (60-85 years old) will receive SCB-1019 (low dose with Alum) at Day 1
干预措施: Candidate vaccine, SCB-1019 (Biological)
group 8 (SCB-1019 high dose without Alum; older adults)
10 older adults (60-85 years old) will receive SCB-1019 (high dose without Alum) at Day 1
干预措施: Candidate vaccine, SCB-1019 (Biological)
group 9 (SCB-1019 high dose with Alum; older adults)
10 older adults (60-85 years old) will receive SCB-1019 (high dose with Alum) at Day 1
干预措施: Candidate vaccine, SCB-1019 (Biological)
group 10 (Placebo; older adults)
4 older adults (60-85 years old) will receive Placebo at Day 1
干预措施: placebo (Biological)
Group 11 (SCB-1019T high dose without Alum; older adults)
30 older adults (60-85 years old) will receive SCB-1019T (high dose without Alum) at Day
干预措施: candidate vaccine, SCB-1019T (Biological)
Group 12 (AREXVY; older adults)
30 older adults (60-85 years old) will receive AREXVY at Day 1
干预措施: AREXVY (Biological)
Group 13 (Placebo; older adults)
10 older adults (60-85 years old) will receive Placebo at Day 1
干预措施: placebo (Biological)
Group 14 (SCB-1019T mid dose with Alum; older adults)
30 older adults (60-85 years old) will receive SCB-1019T (mid dose with Alum) at Day 1
干预措施: candidate vaccine, SCB-1019T (Biological)
结局指标
主要结局
Evaluate the reactogenicity of SCB-1019, SCB-1019T compared with AREXVY vaccine
时间窗: Within 7 days after vaccination
Proportion of participants with local and systemic solicited AEs
Evaluate the safety tolerability of SCB-1019, SCB-1019T compared with AREXVY vaccine
时间窗: Within 28 days after vaccination
Proportion of participants with unsolicited AEs
Evaluate the safety and tolerability of SCB-1019, SCB-1019T compared with AREXVY vaccine
时间窗: Screening and Day 8
Mean change and shift from baseline in hematology, biochemistry and coagulation parameters
次要结局
未报告次要终点