A PHASE 1/2 STUDY TO ASSESS THE SAFETY AND IMMUNOGENICITY OF A BROADLY PROTECTIVE mRNA VACCINE JCXH-221 AGAINST SARS-CoV-2 INFECTION AND DISEASES
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 262
- 试验地点
- 1
- 主要终点
- SAE frequency
研究概览
简要总结
The goal of this clinical trial is to learn about, test, and compare JCXH-221 in healthy volunteers. The main aims to answer are:
- To assess the safety and tolerability of the JCXH-221 vaccine in healthy adult subjects
- To identify an optimal dose for the JCXH-221 vaccine in healthy adult subjects
- To assess the humoral immunogenicity of the JCXH-221 vaccine in healthy adult subjects
- To characterize the cellular immunogenicity of the JCXH-221 vaccine in healthy adult subjects
Participants for Phase I will be randomized to either JCXH-221 or placebo. In Phase 2, participants will be randomized to either JCXH-221 or a FDA approved Active comparator.
详细描述
This is a phase 1/2 study looking to enroll a total of 262 patients.
For phase 1, two cohorts will be explored (18-64 age group and 65+ age group) for a total of 72 subjects. The subjects will be enrolled and randomized to either placebo or JCXH-221. A low dose of JCXH-221 will be explored vs placebo for each age group first. A high dose for those 2 cohorts will be explored once all safety data is reviewed.
Once all of Phase 1 data has been reviewed, Phase 2 enrollment will open. In this portion of the trial, subjects will be enrolled and randomized to either JCXH-221 or a FDA approved Active comparator (Pfizer, Moderna, etc.). A total of 190 patients will be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Investigational product
Patients randomized to this arm will be given the investigational product (JCXH-221).
干预措施: JCXH-221 (Biological)
Placebo
Patients randomized to this arm will be given a placebo vaccine.
干预措施: Placebo (Other)
结局指标
主要结局
SAE frequency
时间窗: Day 1- Day 365 (12 months)
Frequency of serious adverse events (SAEs) characterized by type, severity, duration, and drug relationship, from Day 1 (dosing day) until follow-up completion
Unsolicited treatment-emergent AE frequency
时间窗: Day 1- Day 29 (28 days)
The proportion of subjects with at least 1 unsolicited treatment-emergent AE occurring up to 28 days after dosing (Day 29)
Medical AE frequency
时间窗: Day 1- Day 365 (12 months)
Medically attended AEs (MAAEs) characterized by frequency, severity, duration, and drug relationship, from Day 1 until follow-up completion
Solicited systemic reaction frequency
时间窗: Day 1- Day 8 (7 days)
Solicited systemic reactions characterized by frequency, severity, duration, and drug relationship, recorded up to 7 days after dosing (Day 8)
Injection site reaction
时间窗: Day 1- Day 8 (7 days)
Solicited local reactions at the injection site characterized by frequency, severity, and duration, recorded up to 7 days after dosing (Day 8)
AE frequency
时间窗: Day 1- Day 29 (28 days)
Adverse events (AEs), including unsolicited AEs, characterized by frequency, severity, duration, and drug relationship, for up to 28 days after dosing (Day 29)
次要结局
- SARS-CoV-2 antibody levels(Day 1- Day 181 (~6 months))
- SARS-CoV-2 anti-receptor antibody levels(Day 1- Day 181 (~6 months))