A Phase 1, Dose Escalation, Placebo-Controlled, Adaptive-Design Study to Evaluate the Safety and Immunogenicity of VXCO-102, a mRNA Vaccine Targeting Epstein-Barr Virus (EBV) in Healthy Young Adults
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Number of Participants with Solicited Local and Systemic Reactions
研究概览
简要总结
This is an adaptive design Phase 1 clinical trial to evaluate the safety and immunogenicity of VXCO-102 in healthy adult participants.
详细描述
This first-in-human, dose-escalation Phase 1 trial evaluates the safety, tolerability, and immunogenicity of VXCO-102 in healthy young adults across multiple sites in Australia.
Part A will enroll ~45 participants aged 18-25. After sentinel safety review in each dose cohort, participants will be randomized to receive VXCO-102 or placebo, with a booster at Week 8. If Part A results are favorable, the study may expand to Part B to further assess safety, reactogenicity, and immunogenicity.
All participants will undergo ongoing safety monitoring and immune response assessments through clinical evaluations, sample collection, and participant reporting.
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)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 to 25 years, inclusive
- •Healthy per medical assessment based on self-reported medical history, physical examination, vital signs, and laboratory assessment
排除标准
- •Self-reported or medically-documented significant medical or psychiatric condition that per medical assessment could interfere with study participation
- •Likely or confirmed myocarditis or pericarditis
- •Prior receipt of an investigational EBV vaccine
- •Prior receipt of a licensed vaccine within 56 days prior to Day 1
- •Received more than 10 days of any systemic immunosuppressants or cytotoxic medications within 56 days prior to Day 1, any within 14 days prior to Day 1, or will need immunosuppressants at any time during the study.
- •For participants of childbearing potential: pregnant, breastfeeding or planning to become pregnant during the study
- •Note: Other inclusion and exclusion criteria apply.
研究组 & 干预措施
Group 4
Sodium Chloride administered IM by needle and syringe at Day 1 and Week 8
干预措施: Placebo (Biological)
Group 1
Dose 1 - VXCO-102 administered IM by needle and syringe at Day 1 and Week 8
干预措施: VXCO-102 (Biological)
Group 2
Dose 2 - VXCO-102 administered IM by needle and syringe at Day 1 and Week 8
干预措施: VXCO-102 (Biological)
Group 3
Dose 3 - VXCO-102 administered IM by needle and syringe at Day 1 and Week 8
干预措施: VXCO-102 (Biological)
结局指标
主要结局
Number of Participants with Solicited Local and Systemic Reactions
时间窗: 7 days after each product administration
Number of Participants with Unsolicited Adverse Events
时间窗: Up to 28 days after each product administration
Number of Participants with Serious Adverse Events (SAEs) including Suspected Unexpected Serious Adverse Reactions (SUSARs) and Adverse Events of Special Interest (AESIs)
时间窗: Day 1 to end of study (Day 357)
次要结局
- Rate of neutralizing antibody response(Day 1 and 85)