Double Blinded, Randomized, Placebo Controlled, Dose Finding Trial to Evaluate the Optimal Dose of MV-ZIKA, a New Vaccine Against Zika Virus, in Regard to Immunogenicity, Safety, and Tolerability in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Immunogenicity: Functional anti-Zika antibodies as measured by PRNT
研究概览
简要总结
Double blinded, randomized, placebo-controlled, dose finding, multi-center, phase 1 trial in 48 healthy volunteer subjects.
After completion of screening procedures, the subjects are randomized to one of four treatment groups (different dosage strengths and placebo) All subjects will receive study treatment at day 0 and will return on day 28. Subjects randomized to treatment groups with two vaccinations will receive a second treatment at day 28.
Subjects will return on day 56 for the final visit.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy volunteers aged 18 to 55
- •subjects of child bearing potential must perform reliable method of contraception
排除标准
- •immune deficiency, history of HIV, HBV, HCV
- •drug addiction
- •vaccination within 4 weeks prior to study or planned vaccination during study
- •prior receipt of any Zika vaccine
- •recent infection 1 week prior to screening
- •relevant medical history interfering with aim of study
- •neoplastic disease, hematological malignancy
- •history of autoimmune disease
- •psychological condition that affects ability to participate in the study
- •history of severe adverse reactions to vaccine administration
- •history of anaphylaxis
- •allergic reactions, abnormal lab values, or concomitant medication per decision of the investigator
- •use of immunosuppressive drugs within 30 days before screening or planned use during study
- •receipt of blood products within 120 days before screening or planned use during study
- •pregnancy, unreliable contraception method
- •decision of the investigator
- •regular blood plasma donor
研究组 & 干预措施
High dose - single shot
MV-ZIKA, high dose, one vaccination, day 0
干预措施: Placebo (Other)
Placebo
Physiological saline, two treatments
干预措施: Placebo (Other)
High dose
MV-ZIKA, high dose, two vaccinations, day 0 and day 28
干预措施: MV-ZIKA (Biological)
Low dose
MV-ZIKA, low dose, two vaccinations, day 0 and day 28
干预措施: MV-ZIKA (Biological)
High dose - single shot
MV-ZIKA, high dose, one vaccination, day 0
干预措施: MV-ZIKA (Biological)
结局指标
主要结局
Immunogenicity: Functional anti-Zika antibodies as measured by PRNT
时间窗: 56 days
Functional anti-Zika antibodies as measured by PRNT.
次要结局
未报告次要终点