A Two-center, Randomized, Double-blind, Placebo-controlled, Phase Ib Study to Assess the Safety, Tolerability and Immunogenicity of Two Ascending Doses of the Candidate Vaccine MVA-MERS-S_DF-1 in Healthy Study Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 2
- 主要终点
- Frequency of adverse events associated with MVA-MERS-S_DF-1.
研究概览
简要总结
The study will be a two center, randomized, double blind, placebo controlled study of the MVA MERS S_DF-1 candidate delivered by i.m. injection. To evaluate the MERS-S-specific antibody responses and safety profile induced by the two dosage levels of MVA-MERS-S_DF-1 the data will be compared to a placebo control group.
详细描述
This will be a Phase Ib, two-center study in approximately 160 healthy adults aged 18-55 years
The study is separated in two parts:
Part A:
The study starts with a single center open-label run-in phase of two dose levels (cohort 1 "low dose": 2x10^7 PFU, cohort 2 "high dose": 2x10^8 PFU) in 10 healthy subjects. 5 subjects will be allocated to each dose cohort and will receive immunization on day 0 and day 28.
Part B:
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Double-blinded
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
- •Written informed consent form.
- •Healthy male and female subjects aged 18-55 years.
- •No clinically significant acute health problems as determined from medical history and physical examination at screening visit.
- •Body mass index 18.5 - 30.0 kg/m2 and weight > 50 kg at screening.
- •Non-pregnant, non-lactating female with negative pregnancy test.
- •Males and females who agree to comply with the applicable contraceptive requirements of the protocol.
排除标准
- •Receipt of any vaccine from 2 weeks prior to each trial vac-cination (4 weeks for live vaccines) to 3 weeks after each trial vaccination.
- •Receipt of vaccination against MERS or MVA immunizations.in the medical history.
- •Known allergy to the components of the MVA-MERS-S_DF-1 vaccine product.
- •Evidence in the subject's medical history or in the medical examination that might influence either the safety of the subject or the absorption, distribution, metabolism or excretion of the investigational product.
- •Any confirmed or suspected immunosuppressive or immuno-deficient condition, cytotoxic therapy in the previous 5 years, and/or diabetes.
- •Any chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child.
研究组 & 干预措施
Low Dose
Vaccination with 2x10^7 PFU MVA-MERS-S_DF1. Vaccinations will be administered at days 0, 28 or 56, and 336.
干预措施: MVA-MERS-S_DF1 - Low Dose (Biological)
High Dose
Vaccination with 2x10^8 PFU MVA-MERS-S_DF1. Vaccinations will be administered at days 0, 28 or 56, and 336.
干预措施: MVA-MERS-S_DF1 - High Dose (Biological)
Placebo
Injection with placebo. Injections will be administered at days 0, 28 or 56, and 336.
干预措施: Placebo (Other)
结局指标
主要结局
Frequency of adverse events associated with MVA-MERS-S_DF-1.
时间窗: day 1, 14, 29, 42, 56, 84, 168, 336, 364
Safety and reactogenicity will be assesssed by observation, questionaire and diary. Changes from baseline for safety laboratory measures will be monitored. Occurence of SAE will be collected throughout the entire study duration.
Frequency and severity of local injection site reactogenicity signs and symptoms
时间窗: day 1, 14, 29, 42, 84, 336
次要结局
- Immunogenicity(day 0, 14, 28, 42, 56, 70, 84, 168, 336, 364 (dependent on vaccination scheme))