A Phase 1, Randomized, Double Blind, Active-Controlled Dose-Escalation Study to Assess the Safety and Immunogenicity of Pertussis Acellular Vaccine Adjuvanted With TQL1055 (PAVA)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Reactogenicity
研究概览
简要总结
This is a phase 1 study to evaluate the safety and immunogenicity of the semisynthetic saponin adjuvant TQL1055 administered in combination with an acellular pertussis vaccine.
详细描述
The recent increase in the incidence of pertussis has prompted the need for improvements to current acellular pertussis vaccines. Use of novel adjuvants is one approach to such improvement. TQL1055 is a rationally designed, semisynthetic analog of the licensed Quillaja saponin (QS)-21. It has been designed to maintain adjuvant activity with improved tolerability and greater ease of manufacture.
This is a Phase 1, randomized, double blind, active-controlled sequential-group study, designed to evaluate the safety, tolerability, and immunogenicity of the combination of TQL1055 and acellular pertussis vaccine. The dose of TQL1055 will increase by group.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 50 years of age
- •General good health
- •BMI between 17 and 35 kg/m2
- •Not of childbearing potential OR using adequate contraception
排除标准
- •Pregnant or lactating
- •Prior medical condition that could adversely affect subject safety
- •Clinically significant abnormal laboratory parameter
- •Current acute febrile illness
- •Contraindication to intramuscular injection
- •Contraindication to pertussis vaccination
- •Received pertussis vaccine within 3 years
结局指标
主要结局
Reactogenicity
时间窗: 7 days
Solicited local and systemic adverse events
次要结局
- Incidence of abnormal laboratory test results(28 days)
- Immunogenicity(365 days)
- Adverse Events(365 days)