Phase 1, Randomized, Placebo-Controlled, Observer Blind Study to Evaluate the Safety, Reactogenicity and Immunogenicity of an Investigational Self-Amplifying MRNA Influenza Vaccine in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Number and percentage of subjects with HAI titer ≥1:40, ≥1:80, ≥1:160 and ≥1:320
研究概览
简要总结
This is a Phase 1, first-in-human, randomized, placebo-controlled, observer blind study. The effect of two doses of an investigational vaccine on safety, reactogenicity, kinetics and magnitude of the post-vaccination antibody response will be evaluated at different timepoints as compared to placebo in healthy adults.
Approximately 96 evaluable subjects will be enrolled in this study; n=72 receiving investigational vaccine and n=24 receiving placebo.
The study has a screening period (Day -28 to Day -1), a treatment period (Day 1 to Day 43) and a follow-up period (Day 44 to Day 202).
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
- •Individuals 18 to 49 years of age OR 65 to 85 years of age, inclusive on the day of informed consent.
- •Individuals with body mass index (BMI) between 18 and 32 kg/m2, inclusive, at screening .
- •Individuals who can comply with study procedures including follow-up .
排除标准
- •Female participants of childbearing potential who are pregnant, lactating, or who have not adhered to a specified set of highly effective contraceptive methods from at least 30 days prior to informed consent and who do not plan to do so for the duration of the study.
- •Male participants who have not adhered to using barrier contraception such as a condom during at least 60 days after each vaccination, to prevent semen transfer to their sexual partners and prevent pregnancy of a female partner.
- •Progressive, unstable, or uncontrolled clinical conditions
- •Known hypersensitivity or allergy to any study vaccine component
- •Known history of Guillain-Barré syndrome or other demyelinating disease
- •Condition representing a contraindication to vaccination or blood draw
- •Abnormal function of immune system due to clinical condition, medications, or radiotherapy.
- •Receipt or planning to receive blood products, non-study vaccine, influenza vaccine, mRNA-platform vaccine within different timeframes; previous or from study vaccination.
- •Baseline abnormal clinically significant ECG, laboratory safety parameters or vital signs.
- •Plan to donate blood products (other than for this study), sperm, ova, tissues, or organs up to 60 days following the last vaccination.
研究组 & 干预措施
sa-mRNA vaccine dose 1
干预措施: sa-mRNA vaccine Dose 1 (Biological)
sa-mRNA vaccine dose 2
干预措施: sa-mRNA vaccine Dose 2 (Biological)
sa-mRNA vaccine dose 3
干预措施: sa-mRNA vaccine Dose 3 (Biological)
Placebo
干预措施: Placebo (Biological)
结局指标
主要结局
Number and percentage of subjects with HAI titer ≥1:40, ≥1:80, ≥1:160 and ≥1:320
时间窗: Day 1, Day 22, Day 43
Number and percentage of subjects with clinically significant abnormal vital signs and/or acute reactions
时间窗: up to 60 minutes or within 6 hours post vaccination
Number and percentage of subjects reporting reactogenicity: Solicited local and systemic AEs
时间窗: Day 1 to Day 14 of each post vaccination period
Number and percentage of subjects with Grade 3 or greater abnormal clinically significant hematology and chemistry laboratory values
时间窗: Day 3 to Day 43
Seroconversion rate (SCR) by HAI assay
时间窗: Day 1, Day 22, Day 43
SCR defined as the percentage of subjects with either a prevaccination HAI titer \<1:10 and a post-vaccination HAI titer ≥1:40, or a prevaccination HAI titer ≥1:10 and a ≥4-fold increase in post-vaccination
Number and percentage of subjects with grading shifts in hematology and chemistry laboratory assessments
时间窗: Day 3 to Day 43
Serum antibody titer against the HA glycoprotein in terms of GMT, GMFI, and GMT ratio measured via HI assay
时间窗: Day 1, Day 22, Day 43
Number and percentage of subjects reporting unsolicited AEs
时间窗: Day 1 to Day 43
Number and percentage of subjects reporting AEs leading to study withdrawal, Adverse Events of Special Interest (AESIs), medically attended AEs (MAAEs), and serious adverse events (SAEs).
时间窗: Day 1 to Day 202
Number and percentage of subjects with HAI titer ≥1:10 and <1:10 (lower limit of quantification [LLOQ])
时间窗: Day 1, Day 22, Day 43
次要结局
- Number and percentage of subjects with HAI titer ≥1:10 and <1:10 (LLOQ)(Day 202)
- Number and percentage of subjects with HAI titer ≥1:40, ≥1:80, ≥1:160 and ≥1:320(Day 202)
- Number and percentage of subjects with ≥4-fold increase in post-vaccination ELLA titer(Day 1, Day 22, Day 43, Day 202)
- Number and percentage of subjects with ≥4-fold increase in post-vaccination HAI titer(Day 1, Day 202)
- Seroconversion rate (SCR) by HAI assay(Day 1, Day 202)
- Serum antibody titer against the HA glycoprotein in terms of GMT, GMFI, and GMT ratio measured via HI assay(Day 1, Day 202)
- Serum antibody titer against the NA glycoprotein in terms of GMT, GMFI, and GMT ratio measured via ELLA assay(Day 1, Day 22, Day 43, Day 202)