A Multi-center, Randomized Placebo-controlled Phase II Trial to Assess the Safety, Tolerability and Immunogenicity of Two Doses of the Candidate Vaccine MVA-SARS-2-S in Adults Aged 18 to 64 and 65 and Older
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 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
In this multi-center phase II clinical trial, adults in stable health conditions will be vaccinated twice with either a low dose or high dose of the candidate vaccine MVA-SARS-2-S, or placebo.
The aim of the study is to assess the safety and immunogenicity of the candidate vaccine.
详细描述
The vaccine contains a Modified Vaccinia Virus Ankara (MVA) vector expressing the SARS-CoV-2 spike protein (S).
This will be a combined Phase II, multi-center trial in a total of 580 participants.
The dose finding study will be conducted randomized-controlled, in adults in stable health conditions, including health care workers, COVID-19 risk populations, individuals with advanced age and seropositive individuals.
Male and female individuals in stable health conditions will be stratified for age (18-64 years and 65 and older).
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-blind: two or more parties are unaware of the intervention assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent.
- •Male and female adults in stable health conditions aged 18 - 64 at time of informed consent (participation of health care workers and risk groups will be prioritized) and male or female in stable health conditions aged ≥ 65 at time of informed consent.
- •Either in good or stable health in the opinion of the investigator. Participants may have underlying illness as long as their symptoms are medically controlled, and they are on a stable medication for the respective underlying illness for at least 8 weeks before screening and no changes are expected during the study.
- •Body mass index 18.5 - 32.0 kg/m2 and weight > 50 kg at screening.
- •Non-pregnant, non-lactating female with negative pregnancy test.
- •Females who agree to comply with the applicable contraceptive requirements of the protocol.
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.
- •Evidence of an active SARS-CoV-2 infection.
- •Known allergy to the components of the MVA-SARS-2-S vaccine product such as chicken proteins, 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 vaccine.
- •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 under investigation.
- •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
- Immunogenicity(during the entire study (up to 6 months))