A Phase 1, First-Time-in-Human (FTiH), Observer-blind, Randomized, Controlled Study to Evaluate the Safety, Reactogenicity and Immune Response of Various Doses of an mRNA-based Respiratory Syncytial Virus (RSV) Investigational Vaccine in Healthy Participants 18-45 Years of Age
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 213
- 试验地点
- 10
- 主要终点
- Number of participants with clinically significant hematological and biochemical abnormalities post-Dose 1
研究概览
简要总结
The purpose of this study is to assess the reactogenicity, safety and immune response of various formulations of the RSV mRNA investigational vaccine administered in healthy participants 18-45 years of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Data will be collected in an observer-blind manner
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits).
- •Written informed consent obtained from the participant prior to performance of any study-specific procedure.
- •Healthy participants as established by medical history, clinical examination and laboratory assessment at screening.
- •Male or female between and including 18 and 45 years of age at the time of enrollment into the study.
- •Body mass index more than or equal to (>=) 18 kg/m^2 and less than (<) 40 kg/m^
- •Female participants of non-childbearing potential may be enrolled in the study.
- •Female participants of childbearing potential may be enrolled in the study if the participant:
- •has practiced adequate contraception for 1 month prior to study intervention administration period, and
- •has a negative pregnancy test (on urine sample) on the day of study intervention administration, and
- •has agreed to continue adequate contraception during the entire treatment period and for at least 1 month after completion of the study intervention administration series.
排除标准
- •Medical conditions
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions.
- •Hypersensitivity to latex.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
- •Recurrent history or uncontrolled neurological disorders or seizures.
- •Documented HIV, HBV, or HCV-positive participant.
- •Lymphoproliferative disorder or malignancy within 5 years before the first dose of study intervention administration.
- •History of or current suspicion of myocarditis or pericarditis.
- •Prior/Concomitant therapy
- •Use of any investigational or non-registered product (drug, vaccine, or invasive medical device) other than the study intervention during the period beginning 30 days before the first dose of study intervention administration (Day -29 to Day 1), or their planned use during the study period.
- •Has previously received an investigational or approved vaccine or antibody for prevention of RSV infection.
- •Planned administration/administration of a vaccine in the period starting 30 days before the first dose and ending 30 days after the last dose of study intervention administration, except for inactivated vaccines for influenza if they are received at least 14 days before the first dose or 14 days after the last study intervention administration.
- •Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the end of the study.
- •Prior/Concurrent clinical study experience
- •Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device).
- •Other exclusion criteria
- •Pregnant or lactating female participant.
- •Female participant planning to become pregnant or planning to discontinue contraceptive precautions within 1 month following the last study intervention administration.
- •Alcoholism or substance use disorder within the past 24 months.
- •Any study personnel or their immediate dependents, family, or household members.
- •Participants with extensive body markings or conditions in the deltoid region that may preclude accurate assessment of local reactogenicity.
研究组 & 干预措施
RSV_Group E
干预措施: Investigational RSV vaccine 5 (Biological)
RSV_Group F
干预措施: Investigational RSV vaccine 6 (Biological)
RSV_Group D
干预措施: Investigational RSV vaccine 4 (Biological)
RSV_Group F
干预措施: Placebo (Drug)
Placebo Group
干预措施: Placebo (Drug)
RSV_Group B
干预措施: Investigational RSV vaccine 2 (Biological)
RSV_Group C
干预措施: Investigational RSV vaccine 3 (Biological)
RSV_Group A
干预措施: Investigational RSV vaccine 1 (Biological)
结局指标
主要结局
Number of participants with clinically significant hematological and biochemical abnormalities post-Dose 1
时间窗: At Day 8
Number of participants reporting solicited systemic events within 7 days post-Dose 1
时间窗: From Day 1 to Day 7
Number of participants reporting solicited administration site events within 7 days post-Dose 2
时间窗: From Day 30 to Day 36
Number of participants reporting solicited administration site events within 7 days post-Dose 1
时间窗: From Day 1 to Day 7
Number of participants reporting solicited systemic events within 7 days post-Dose 2
时间窗: From Day 30 to Day 36
Number of participants reporting unsolicited adverse events (AEs) within 29 days post-Dose 1
时间窗: From Day 1 to Day 29
Number of participants reporting unsolicited AEs within 29 days post-Dose 2
时间窗: From Day 30 to Day 58
Number of participants reporting serious adverse events (SAEs)
时间窗: From Day 1 (Dose 1) up to Month 7 (6 months post-Dose 2)
Number of participants reporting medically attended adverse events (MAAEs)
时间窗: From Day 1 (Dose 1) up to Month 7 (6 months post-Dose 2)
Number of participants reporting adverse event of special interest (AESI)
时间窗: From Day 1 (Dose 1) up to Month 7 (6 months post-Dose 2)
Number of participants reporting fatal SAEs
时间窗: From Day 1 (Dose 1) up to Month 13 (study end)
Number of participants reporting related SAEs
时间窗: From Day 1 (Dose 1) up to Month 13 (study end)
Number of participants reporting related AESIs
时间窗: From Day 1 (Dose 1) up to Month 13 (study end)
Number of participants with clinically significant hematological and biochemical abnormalities at pre-Dose 1
时间窗: At Day 1
Number of participants with clinically significant hematological and biochemical abnormalities post-Dose 1
时间窗: At Day 30
Number of participants with clinically significant hematological and biochemical abnormalities post-Dose 2
时间窗: At Day 37
次要结局
- RSV- A neutralizing titers expressed as Geometric mean titers (GMTs)(At Day 1 (pre-Dose 1), Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7 and Month 13 (post-Dose 2))
- RSV- B neutralizing titers expressed as GMTs(At Day 1 (pre-Dose 1), Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7 and Month 13 (post-Dose 2))
- Geometric mean fold increase in serum neutralizing titers against RSV-A from baseline(Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7 and Month 13 (post-Dose 2) compared with baseline (Day 1, pre-Dose 1))
- Geometric mean fold increase in serum neutralizing titers against RSV-B from baseline(Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7 and Month 13 (post-Dose 2) compared with baseline (Day 1, pre-Dose 1))
- Number of participants with seroresponse in terms of neutralizing titer against RSV-A(Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7 and Month 13 (post-Dose 2) compared with baseline (Day 1, pre-Dose 1))
- Number of participants with seroresponse in terms of neutralizing titer against RSV-B(Day 8 and Day 30 (post-Dose 1), Day 37, Day 59, Month 7 and Month 13 (post-Dose 2) compared with baseline (Day 1, pre-Dose 1))