A Multi-center Phase Ib Trial to Assess the Safety, Tolerability and Immunogenicity of the Candidate Vaccine MVA-SARS-2-ST in Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 4
- 主要终点
- Percentage of Participants Experiencing Solicited Local or Systemic Reactogenicity as Defined by the Study Protocol
研究概览
简要总结
Multi-center phase Ib study to evaluate the Modified Vaccinia Virus Ankara (MVA) vaccine against SARS-CoV-2 in seronegative (Part A) and previously SARS-CoV-2-vaccinated individuals (Part B).
详细描述
The vaccine contains a Modified Vaccinia Virus Ankara (MVA) vector expressing a stabilized SARS-CoV-2 spike protein (S).
This will be a phase Ib multi-center study in approximately 60 adults aged 18-64 years.
Part A (N=24 seronegative subjects). Each participant will receive two single injections, 28 days apart.
- low dose ≥ 1 x 10e7 IU (N=8)
- middle dose ≥ 5 x 10e7 IU (N=8)
- high dose ≥ 1 x 10e8 IU (N=8)
Part B (N=36 previously mRNA vaccinated subjects). Each participant will receive a single injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent.
- •Healthy male and female adults aged 18 - 64 at time of informed consent.
- •Body mass index 18.5 - 32.0 kg/m2 and weight > 50 kg at screening.
- •Female participants: non-pregnant, non-lactating with negative pregnancy test.
- •Females who agree to comply with the applicable contraceptive requirements of the protocol.
- •≥ 6 months fully vaccinated with a (conditionally)licensed mRNA vaccine against COVID-19 (Part B only)
排除标准
- •Receipt of any vaccine from 4 weeks prior to each trial vaccination (8 weeks for live vaccines) to 6 weeks after each trial vaccination.
- •Previous rMVA immunization.
- •Previous immunization with investigational vaccine against COVID-
- •Previous immunization with EUA/conditionally licensed vaccine against COVID-19 (not applicable to Part B).
- •Evidence of active SARS-CoV-2 infection
- •Known allergy to the components of the MVA-SARS-2-ST vaccine product or history of life-threatening reactions to vaccine containing the same substances.
- •Known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccines.
- •Evidence in the participant's medical history or in the medical examination that might influence either the safety of the participant or the absorption, distribution, metabolism or excretion of the investigational product.
- •Clinically relevant findings in ECG or significant thromboembolic events in medical history.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 5 years, and/or uncontrolled diabetes (HbA1c ≥ 7.0).
- •Any known chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child.
结局指标
主要结局
Percentage of Participants Experiencing Solicited Local or Systemic Reactogenicity as Defined by the Study Protocol
时间窗: during the entire study (up to 6 months)
Safety and reactogenicity will be assessed by observation, questionaire and diary. Occurence of Serious Adverse Events (SAE) will be collected throughout the entire study duration.
次要结局
- Number of participants who seroconverted(during the entire study (up to 6 months))