A Phase 2, Randomized, Triple-Blinded, Active-Controlled Study to Assess the Safety and Immunogenicity of an Investigational Herpes Zoster (HZ) Vaccine, JCXH-105, in Healthy Subjects ≥ 50 Years of Age
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 467
- 试验地点
- 7
- 主要终点
- SAE Frequency
研究概览
简要总结
The goal of this clinical trial is to assess the safety and immunogenicity of an srRNA-based vaccine, JCXH-105, in the prevention of Herpes Zoster (Shingles).
Subjects will be randomized to receive either JCXH-105 or Shingrix.
详细描述
This Phase 2 study plans to enroll a total of 460 subjects.
This will be an active-controlled study in healthy male and/or female subjects 50 years of age or older. Subjects will be randomized 1:1 to receive either JCXH-105 or Shingrix. The study vaccine will be administered in two doses approximately 2 months apart. The subject will receive a single intramuscular (IM) injection of JCXH-105 or Shingrix on Day 1 (Dose 1) and again on Day 61 ± 7 days (Dose 2). For each subject, Dose 1 and Dose 2 are the same study vaccine based on randomization on Day 1. A total of 460 subjects will be enrolled into this trial and vaccinated with either JCXH-105 (n=230) or Shingrix (n=230).
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
Triple-blinded study
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sex: Male or female; female subjects may be of childbearing potential, of nonchildbearing potential, or postmenopausal.
- •Age: ≥ 50 years of age at screening.
- •Status: Healthy subjects.
- •Subjects must agree to not be vaccinated with any HZ vaccine while participating in this study.
- •Subjects must agree to not be vaccinated with any RNA-based vaccines (e.g., Spikevax, Comirnaty, etc.) 30 days before Dose 1 through 30 days after Dose 2 (a 4-month period).
排除标准
- •Subjects with a history of HZ within the past 10 years or current diagnosis of HZ.
- •Previous vaccination against HZ.
- •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 the first vaccine administration (JCXH-105 or Shingrix).
- •Subjects who are acutely ill or febrile with body temperature ≥ 38.0º Celsius/100.4º Fahrenheit 72 hours prior to or at the Screening visit or on Day 1 pre-dose. Subjects meeting this criterion may be rescheduled within an allowable window with approval from the Sponsor.
- •Subjects with history or current diagnosis of congenital or acquired immunodeficiency/immunocompromising/immunosuppressive conditions, asplenia, or recurrent severe infections. Certain immune-mediated conditions (e.g., Hashimoto thyroiditis) that are well controlled and stable are allowed.
- •Subjects with history of myocarditis or pericarditis, or with AEs (including anaphylaxis and severe hypersensitivity) after mRNA vaccination that are in nature and severity beyond the common expected AEs and necessitating medical intervention.
- •Subjects who received any non-live vaccine within 14 days prior to Day 1 (first dose of JCXH-105 or Shingrix).
- •Subjects who received within 28 days prior to Day 1 (first dose of JCXH-105 or Shingrix): (1) Any live vaccine, (2) Immunomodulators or immune-suppressive medication, (3) Granulocyte or granulocyte-macrophage colony-stimulating factor, (4) Three or more consecutive days of systemic corticosteroids. Note: subjects on stable-dose steroid replacement (for chronic disease such as iatrogenic deficiency) of prednisone ≤10 mg/day or equivalent are allowed and (5) Other investigational agents or devices.
- •Subjects receiving systemic antiviral therapy.
- •Subjects with a positive screening test for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, anti-human HIV-1 and 2 antibodies, or syphilis.
- •Subjects with a positive screening test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
研究组 & 干预措施
Investigational Product
Participants randomized to this arm will be given the investigational product (JCXH-105).
干预措施: JCXH-105 (Biological)
Active Control
Participants randomized to this arm will be given the FDA approved Shingrix.
干预措施: Shingrix (Biological)
结局指标
主要结局
SAE Frequency
时间窗: Day 1 - Day 241 (Week 34)
Frequency of SAEs characterized by type, severity, duration, and relationship to the vaccine recorded from Day 1 post-vaccine administration through follow-up completion.
Solicited local reaction frequency
时间窗: Day 1 - Day 7 (After Dose 1), Day 1 - Day 7 (After Dose 2)
Occurrence of solicited local injection site reactions characterize by frequency, severity, and duration within 7 days after each vaccine administration.
Solicited systemic reaction frequency
时间窗: Day 1 - Day 7 (After Dose 1), Day 1 - Day 7 (After Dose 2)
Occurrence of solicited systemic reactions characterize by frequency, severity, and duration within 7 days after each vaccine administration.
AE Frequency
时间窗: Day 1 - Day 241 (Week 34)
Adverse events (AEs) including unsolicited AEs and any AEs leading to discontinuation of study vaccine or withdrawal from the study, characterized by frequency, severity, duration, and relationship to the vaccine from Day 1 post-vaccine administration through follow-up completion.
AESIs Frequency
时间窗: Day 1 - Day 241 (Week 34)
AESIs characterized by frequency, severity, duration, and relationship to the vaccine from Day 1 post-vaccine administration through follow-up completion.
Medically Attended AE Frequency
时间窗: Day 1 - Day 241 (Week 34)
Medically attended AEs (MAAEs) characterized by frequency, severity, duration, and relationship to the vaccine from Day 1 post-vaccine administration through follow-up completion.
Immune-Mediated Adverse Events of Special Interest Frequency
时间窗: Day 1 - Day 241 (Week 34)
Immune-mediated adverse events of special interest (imAESIs) characterized by frequency, severity, duration, and relationship to the vaccine (JCXH-105 or Shingrix) recorded from Day 1 post-vaccine administration through follow-up completion.
gE-Specific CD4+ T cell Response Rate
时间窗: Day 1 - Day 89 (Week 13)
Response Rate is defined at the percentage of subjects with ≥ 2 folds increase of gE-specific CD4+ T cells expressing 2 or more markers of activation (IFN-γ, IL-2, TNFα, and CD40L) in PBMCs analyzed with flow cytometry with ICS on Day 89 as compared to baseline (Day 1 pre-dose).
次要结局
- Cellular immunogenicity of JCXH-105(Day 1 - Day 241 (Week 34))