A Phase 1, First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose-Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of PRV-101, a Coxsackie Virus B (CVB) Vaccine, in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Incidence and severity of treatment-emergent adverse events (safety and tolerability)
研究概览
简要总结
Phase 1, first-in-human, randomized, double-blind, placebo-controlled, multiple-dose-escalation study to evaluate the safety, tolerability and immunogenicity of PRV-101, a coxsackie virus B vaccine, in healthy volunteers.
详细描述
Thirty two healthy adult subjects will be enrolled into 2 dose cohorts (low-dose and high-dose cohorts, 16 subjects per cohort) and will be randomized in a double-blind manner to PRV-101 or placebo in a 3:1 ratio. Each subject will receive up to 3 administrations of the study drug (PRV-101 or placebo) at 4-week intervals and will be followed for 24 weeks after the final dose. Each cohort will start with a sentinel dosing group (2 subjects). Cohort 2 will commence after safety data from the first 2 doses from all Cohort 1 participants are reviewed.
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)
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
- •Healthy adults, males and females, ages 18 to 45 yrs, with BMI 19 to 30 kg/m2
- •Women of childbearing potential must have negative pregnancy test and agree to use an acceptable method of highly effective contraceptive
- •Men must either have a vasectomy or agree to use highly effective contraception
排除标准
- •Prior or current clinically significant medical illness or disorder
- •Has celiac disease or type 1 diabetes or related autoantibodies
- •Has active acute or chronic/latent infection, or history of recent serious infection
- •Recent acute illness or recent major illness, hospitalization or surgery
- •Recent history of alcohol or drug abuse
- •Received an experimental antibody or biologic therapy in last 6 months
- •Received live, inactivated or subunit virus vaccine or a bacterial vaccine within last 4 weeks
- •Intolerance or hypersensitivity to vaccines or vaccine components or has a drug or food allergy or allergic disease requiring medication
研究组 & 干预措施
Cohort 1, Low Dose, Placebo
Low dose of placebo by intramuscular injection, 3 doses at 4-week intervals
干预措施: Placebo (Other)
Cohort 2, High Dose, Placebo
High dose of placebo by intramuscular injection, 3 doses at 4-week intervals
干预措施: Placebo (Other)
Cohort 2, High Dose, PRV-101
High dose of PRV-101 by intramuscular injection, 3 doses at 4-week intervals
干预措施: PRV-101 (Biological)
Cohort 1, Low Dose, PRV-101
Low dose of PRV-101 by intramuscular injection, 3 doses at 4-week intervals
干预措施: PRV-101 (Biological)
结局指标
主要结局
Incidence and severity of treatment-emergent adverse events (safety and tolerability)
时间窗: Throughout the 32 weeks of the study
Adverse events will be assessed by frequency and criteria for severity (mild, moderate or severe)
次要结局
- Titer of antibodies to coxsackie B virus (immunogenicity, efficacy)(Days 1, 29 and 57 and weeks 12 and 32)
- Development of neutralizing antibodies to coxsackie B virus (immunogenicity, efficacy)(Days 1, 29, and 57 and Weeks 12 and 32)