A Phase 1 Randomized, Double-Blinded Study to Assess the Safety, Reactogenicity and Immunogenicity of JCXH-108, an mRNA-based Investigational Vaccine Against Respiratory Syncytial Virus (RSV) in Healthy Subjects ≥ 60 Years of Age and 18-45 Years of Age
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
- 试验地点
- 6
- 主要终点
- Medically attended AE frequency
研究概览
简要总结
The goal of this clinical trial is to assess the safety, reactogenicity and immunogenicity of an mRNA-based vaccine, JCXH-108, the prevention of Respiratory Syncytial Virus (RSV) infection and diseases.
Participants will be randomized to receive either JCXH-108 or placebo.
详细描述
This Phase 1 study plans to enroll a total of 75 participants.
Three cohorts with two different dose levels will be explored and each cohort will enroll 25 participants. Participants in each cohort will be randomized (4:1) to receive either JCXH-108 (n=20) or placebo (normal saline, n=5). A low dose of JCXH-108 will be explored vs placebo in the 18-45 years of age group first. A high dose will be explored vs placebo in the 18-45 years and ≥ 60 years of age groups once safety data is reviewed for the Sentinel subjects in the low dose cohort. The dose level of JCXH-108 will depend on the time the participant joins the study. Each participant will receive a single dose of JCXH-108 administered intramuscularly (IM) on day 1.
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)
盲法说明
Double-blinded study
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Main Inclusion Criteria:
- •Sex: Male or female; female subjects may be of childbearing potential or postmenopausal.
- •Age: 18-45 years of age or ≥ 60 years of age at screening
- •Status: Healthy subjects.
- •Subjects must agree to not be vaccinated with any RSV vaccine while participating in this study.
- •Subjects must agree to not be vaccinated with any RNA-based vaccines 30 days before D1 through 30 days after D
排除标准
- •Subjects with current diagnosis of RSV infection or diseases.
- •Previous vaccination against RSV.
- •Subjects with any respiratory illness deemed clinically relevant by the Investigator within the past month OR hospitalization >24 hours for any reason within the past month prior to Day
- •Subjects with history of myocarditis or pericarditis, or with adverse events (AEs) after mRNA vaccination that are in nature and severity beyond the common expected AEs necessitating medical intervention.
- •Subjects who received any non-live vaccine within 14 days prior to Day
- •Subjects who received within 28 days prior to Day 1: (1) Any live vaccine, (2) Immunomodulators or immune-suppressive medication, (3) Granulocyte or granulocyte-macrophage colony-stimulating factor, and (4) Three or more consecutive days of systemic corticosteroids. Note: subjects on stable dose of steroid replacement (for chronic disease such as iatrogenic deficiency) of prednisone ≤10 mg/day or equivalent are allowed.
- •Subjects who currently receive other investigational agents or devices.
- •Subjects with active or suspected immunosuppression, immunodeficiency, asplenia, recurrent severe infections or autoimmune diseases. Certain immune-mediated conditions (e.g., Hashimoto thyroiditis) that are well controlled and stable are allowed.
- •Subjects receiving systemic antiviral therapy.
- •Subjects with a positive screening test for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or anti-human HIV-1 and 2 antibodies, syphilis.
- •Subjects with a positive test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Screening or on Day 1 prior to vaccine administration (JCXH-108 or placebo).
研究组 & 干预措施
Placebo
Subjects randomized to this arm will be given a placebo.
干预措施: Placebo (Other)
Investigational product
Subjects randomized to this arm will be given the investigational product (JCXH-108).
干预措施: JCXH-108 (Biological)
结局指标
主要结局
Medically attended AE frequency
时间窗: Day 1 - Day 180 (6 Months)
Medically attended AEs (MAAEs) characterized by frequency, severity, duration, and relationship to the vaccine (JCXH-108 or Placebo) recorded from Day 1 post-vaccine administration (JCXH-108 or Placebo) through follow-up completion
Potential immune-mediated adverse events frequency
时间窗: Day 1 - Day 180 (6 Months)
Potential immune-mediated disease (pIMDs) characterized by frequency, severity, duration, and relationship to the vaccine (JCXH-108 or Placebo) recorded from Day 1 post-vaccine administration (JCXH-108 or Placebo) through follow-up completion
SAE Frequency
时间窗: Day 1 - Day 180 (6 Months)
Frequency of SAEs characterized by type, severity, duration, and relationship to the JCXH-108 recorded from Day 1 (D1) post-vaccine administration through follow-up completion.
Injection site reaction
时间窗: Day 1 - Day 30
Solicited local injection site reactions characterized by frequency, severity, and duration recorded within 30 days after administration after vaccine administration (JCXH-108 or Placebo)
AE frequency
时间窗: Day 1 -Day 30
Adverse events (AEs) including unsolicited AEs characterized by type, severity, duration, and relationship to the vaccine (JCXH-108 or Placebo) recorded from Day 1 post-vaccine administration to within 30 days following vaccine administration
Solicited systemic reaction frequency
时间窗: Day 1 - Day 30
Solicited systemic adverse reactions characterized by frequency, severity, and duration recorded within 30 days after vaccine administration (JCXH-108 or Placebo)
次要结局
- RSV-A and RSV-B antibody levels(Day 1 - Day 180 (6 Months))
- IgG antibody levels(Day 1 - Day 30)