A Phase 2 Parallel-Group, Randomized, Double-Blind Study to Assess the Safety and Immunogenicity of PXVX0317 (Chikungunya Virus Virus-Like Particle Vaccine [CHIKV-VLP], Unadjuvanted or Alum-adjuvanted)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 445
- 试验地点
- 6
- 主要终点
- Anti-CHIKV Neutralizing Antibody Geometric Mean Titer 28 Days After the Last Injection for Groups 2-8.
研究概览
简要总结
The goal of this Phase 2 trial is to evaluate the immune response to and safety profile of various doses/formulations/and schedules of administration of PXVX0317 in healthy adults.
Primary Objective:
To assess the immune response to the vaccine
Secondary Objectives:
To assess the kinetics of the immune response to different doses/formulations/schedules To assess the persistence of immune responses to different doses/formulations/schedules To assess the effect of a booster dose of the vaccine
Safety Objective:
To assess local and systemic reactions to the vaccine and to describe the safety profile of the vaccine
详细描述
The trial will explore 8 formulation/schedule combinations of CHIKV VLP vaccine with or without Alhydrogel adjuvant, and will also explore different dose schedules of Day 1 and 15 or Day 1 and 29 or Day 29 only.
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
- •Male or female
- •Age 18 to 45 years old (inclusive)
- •Using an acceptable method of contraception (if female of childbearing potential).
- •Able and willing to provide informed consent for study participation.
排除标准
- •Current acute febrile illness.
- •Clinically significant cardiac, respiratory, or rheumatologic disease, in the opinion of the Investigator.
- •Pregnant or breast-feeding.
- •Laboratory evidence of infection with Hepatitis B/C or HIV.
- •History of chikungunya virus infection.
- •Travel to a World Health Organization-designated chikungunya-endemic region within 30 days prior to Day
- •History of allergic reaction to any component of CHIKV-VLP vaccine, Diluent, or Alhydrogel®.
- •Inability to discontinue systemic immunomodulatory or immunosuppressive medications 30 days prior to Day
- •Received or plans to receive any licensed vaccine from 30 days prior to Day 1 through Day
- •Received or plans to receive an investigational agent from 30 days prior to Day 1 through the duration of study participation.
- •Any other condition that, in the opinion of the Investigator, creates an unacceptable risk to the subject.
- •Any other condition that, in the opinion of the Investigator, may interfere with the conduct of the study or the validity of the data.
- •Any other condition that, in the opinion of the Investigator, creates an unacceptable safety risk for apheresis (Group 9 & 10 only).
- •Restricted venous access that would prevent the collection of PBMCs, plasma, and lymphocytes necessary for participation (Group 9 & 10 only).
- •Weight < 110 pounds (Group 9 & 10 only)
结局指标
主要结局
Anti-CHIKV Neutralizing Antibody Geometric Mean Titer 28 Days After the Last Injection for Groups 2-8.
时间窗: Day 57 (from Day 1 vaccination), 28 days after the last injection.
To assess the induction of anti-chikungunya virus (CHIKV) neutralizing antibody geometric mean titers by different formulations and schedules, as measured at 28 days after the last injection (Day 57) for Groups 2-8.
次要结局
- Kinetics of Anti-chikungunya Virus (CHIKV) Neutralizing Antibody Geometric Mean Titer for Groups 2-8.(At Days 8, 15, 22, 29, 36, and 57.)
- Differences in Persistence of Neutralizing Antibody Geometric Mean Titer for Groups 2-8.(At Days 182, 365, 547, and 760.)
- Boosting of Vaccine-induced Neutralizing Antibody Geometric Mean Titer by a Booster Dose of PXVX0317 for Group 4 Only.(Antibody levels will be measured at Day 547 prior to the booster dose and again 28 days later on Day 575 and then at Day 760.)
- Percentage of Participants With an Anti-CHIKV Neutralizing Antibody Titer Exceeding the Following Cutoff Values: ≥15, 40, 160, 640, and 4-fold Rise Over Baseline.(Day 57 (from Day 1 vaccination), 28 days after the last injection.)