A Phase 1/2, Randomized, Observer-blind, First-in-human Study to Describe the Safety, Reactogenicity and Immunogenicity of SCB-1022, a Combination Recombinant RSV-hMPV Protein Subunit Vaccine Candidate, and SCB-1033, a Combination Recombinant RSV-hMPV-PIV3 Protein Subunit Vaccine Candidate in Healthy Older Adults Aged 60-85 Years
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 612
- 试验地点
- 4
- 主要终点
- To evaluate the safety and reactogenicity of SCB-1022 and SCB 1033 compared to SCB-1019T (Part 1 and Part 2) or Placebo (Part 3).
研究概览
简要总结
This phase 1/2 study will evaluate the safety, reactogenicity and immunogenicity of SCB-1022 and SCB-1033 compared to SCB-1019T (Parts 1 and 2) or Placebo (Part 3).
详细描述
In Part 1 and Part 2, the study will descriptively evaluate three dose levels of SCB-1022 and SCB-1033. Part 3 will descriptively compare SCB-1022 and SCB-1033 against placebo.
The sample size of this study is not based on formal statistical hypothesis testing but is acceptable for safety and immunogenicity evaluation in a phase 1/2 study. The study will be overseen by a safety monitoring committee.
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
- 60 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.
- •Please refer to Protocol for full list of Inclusion and
排除标准
- •Exclusion Criteria:
- •Pregnancy or potential to become pregnant during the study.
- •Acute disease or fever (≥38°C) at time of vaccination.
- •History of Guillain-Barré Syndrome (GBS).
- •Recurrent or un-controlled neurological disorders or seizures.
- •Serious or unstable chronic illnesses. Please refer to Protocol for full list of Inclusion and Exclusion criteria.
研究组 & 干预措施
Group 6 (SCB-1033 dose level 2)
24 adults to receive dose level 2 of SCB-1033 at Day 1
干预措施: SCB-1033 (Biological)
Group 1 (SCB-1022 dose level 1)
24 adults to receive dose level 1 of SCB-1022 at Day 1
干预措施: SCB-1022 (Biological)
Group 2 (SCB-1022 dose level 2)
24 adults to receive dose level 2 of SCB-1022 at Day 1
干预措施: SCB-1022 (Biological)
Group 3 (SCB-1033 dose level 1)
24 adults to receive dose level 1 of SCB-1033 at Day 1
干预措施: SCB-1033 (Biological)
Group 5 (SCB-1022 dose level 3)
24 adults to receive dose level 3 of SCB-1022 at Day 1
干预措施: SCB-1022 (Biological)
Group 7 (SCB-1033 dose level 3)
24 adults to receive dose level 3 of SCB-1033 at Day 1
干预措施: SCB-1033 (Biological)
Group 9 (SCB-1022 Formulation 1)
105 adults to receive formulation 1 of SCB-1022 at Day 1
干预措施: SCB-1022 (Biological)
Group 10 (SCB-1022 Formulation 2)
105 adults to receive formulation 2 of SCB-1022 at Day 1
干预措施: SCB-1022 (Biological)
Group 11 (SCB-1033)
105 adults to receive SCB-1033 at Day 1
干预措施: SCB-1033 (Biological)
Group 12 Placebo (saline)
105 adults to receive placebo at Day 1
干预措施: Placebo (saline) (Biological)
Group 4 (SCB-1019T)
24 adults to receive SCB-1019T at Day 1
干预措施: SCB-1019T (Biological)
Group 8 (SCB-1019T)
24 adults to receive SCB-1019T at Day 1
干预措施: SCB-1019T (Biological)
结局指标
主要结局
To evaluate the safety and reactogenicity of SCB-1022 and SCB 1033 compared to SCB-1019T (Part 1 and Part 2) or Placebo (Part 3).
时间窗: Within 7 days after vaccination
Proportion of participants with local and systemic solicited AEs
To evaluate the safety and reactogenicity of SCB-1022 and SCB-1033 compared to SCB-1019T (Part 1 and Part 2) or Placebo (Part 3).
时间窗: Within 28 days after vaccination
Proportion of participants with unsolicited AEs
To evaluate the safety and reactogenicity of SCB-1022 and SCB-1033 compared to SCB-1019T (Part 1 and Part 2) or placebo (Part 3).
时间窗: Throughout the study period, from enrollment up to 2 years follow-up
Proportion of participants with SAEs, AESIs, MAAEs, AEs leading to early termination from the study
To evaluate the safety and reactogenicity of SCB-1022 and SCB-1033 compared to SCB-1019T (Part 1 and Part 2).
时间窗: Screening and day 8
Mean change and shift from baseline in hematology, biochemistry and coagulation parameters; by safety set.
To evaluate the safety and reactogenicity of SCB-1022 and SCB 1033 compared to SCB-1019T.
时间窗: Screening and day 8
Mean change and shift from baseline in hematology, biochemistry and coagulation parameters; by safety set.
次要结局
未报告次要终点