Safety, Reactogenicity and Immunogenicity of a Novel MVA-SARS-2-ST Vaccine Candidate Administered as Inhalation Boost in SARS-CoV-2 Immunized Adults - Phase I Study
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 3
- 主要终点
- The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST
研究概览
简要总结
This will be a phase I, single-center trial, including a total of 30 participants in two cohorts.
Cohort 1 (n=6): Healthy male or female adults aged 18 - ≤ 60 previously primary immunized with two vaccinations with any regimen using any EU marketed SARS-CoV-2 vaccine (mRNA-, vector-, protein-based, attenuated SARS-CoV-2 virus) or with a single application of COVID-19 Vaccine Janssen.
Cohort 2 (n=24): Healthy male or female adults aged 18 - ≤ 60 primary immunized with two vaccinations with any regimen using any EU marketed SARS-CoV-2 vaccine (mRNA-, vector-, protein-based, attenuated SARS-CoV-2 virus) or with a single application of COVID-19 Vaccine Janssen and subsequently booster immunized with any EU marketed mRNA vaccine
Both cohorts will be assigned to inhaled vaccination with MVA-SARS-2-ST
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject must not be enrolled before all inclusion criteria (including test results) are confirmed. Subjects meeting all of the criteria listed below will be included in the study.
- •Signed written informed consent from subject prior to any study-related procedure and willingness to comply with treatment and follow-up procedures
- •Healthy men or women, aged ≥ 18 ≤ 60 at day of inclusion having received either
- •primary immunization (cohort 1) with any regimen using any EU marketed SARS- CoV-2 vaccine or
- •subsequently booster immunization (cohort 2) with any EU marketed mRNA vaccine
- •at least 3 months prior to enrollment
- •Adults with SARS-CoV-2 specific IgG concentration between 10 RU/ml and 1200 RU/ml determined by Anti-SARS-CoV-2-QuantiVac-ELISA (IgG)
- •Males or non-pregnant, non-lactating females of child-bearing potential with negative pregnancy test at screening who agree to comply with the applicable contraceptive requirements of the protocol (Section 3.4) from at least 14 days prior to vaccination and during the entire duration of the study.
- •Females without child-bearing potential defined as follows:
- •at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy or
- •hysterectomy or uterine agenesis or
- •≥ 50 years and in postmenopausal state > 1 year or
- •< 50 years and in postmenopausal state > 1 year with serum FSH > 40 IU/l and serum estrogen < 30 ng/l or a negative estrogen test, both at screening
- •Normal pulmonary function: FEV1 predicted ≥ 80% and FEV1/FVC > 70%
- •Body mass index 18.5 - 30.0 kg/m2 and weight > 50 kg at screening
- •Subject is capable of understanding the investigational nature, potential risks and benefits of the clinical trial
排除标准
- •Subjects are excluded from the study if any of the following criteria are met at screening or on dosing day.
- •Previous MVA or rMVA vaccination
- •Known allergy to the components of the SARS-CoV-2 vaccine product 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
- •Any laboratory value outside the reference range that the investigator considers to be of clinical relevance; safety laboratory screening evaluation can be repeated a maximum of two times
- •Any finding in the medical history and physical examination deviating from normal and assessed as clinically relevant by the investigator
- •Evidence in the subject's medical history or in the medical examination that might influence the absorption, distribution, metabolism or excretion of the investigational medicinal product
- •Current smoking/ vaping or smoking /vaping in the previous year.
- •Clinically relevant findings in ECG
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 5 years, and/or diabetes
- •Asthma, chronic obstructive pulmonary disease or other lung disease
- •Respiratory tract infection in the 4 weeks prior to study treatment
- •Any chronic or active neurologic disorder, including seizures, and epilepsy, excluding a single febrile seizure as a child
- •Known intolerance to medication used during bronchoscopy, i.e. midazolam and lidocaine.
- •Treatment with ß-adrenoceptor antagonists
- •Alcohol abuse (consumption of more than 20 g per day for females and 30 g per day for males)
- •Drug abuse or positive drug screening
- •Any positive result for HIV1/2, HCV antibody or HBs antigen testing
- •Moderate or severe illness and/or fever >38 °C within 1 week prior to vaccination
- •History of blood donation within 60 days of enrollment or plans to donate within the treatment phase
- •Participation in a clinical trial or use of an investigational product within 30 days or five times the half-life of the investigational product -whichever is longer- prior to receiving the first dose within this study
- •Investigator or employee of the study site or Sponsor with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, natural or adopted child) of the investigator or employee with direct involvement in the proposed study
研究组 & 干预措施
1 x 107 IU/dose MVA-SARS-2-ST
All Participants will receive a single booster dose of 1 x 107 IU MVA-SARS-2-ST in 0.5 mL as inhalation (total inhaled volume 0.5 mL)
干预措施: MVA-SARS-2-ST (Biological)
结局指标
主要结局
The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST
时间窗: day 7
Occurrence of solicited local reactogenicity signs and symptoms
Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST
时间窗: day 7
Occurrence of solicited systemic reactogenicity signs and symptoms vaccination
Occurrence of unsolicited adverse events (AE) associated with MVA-SARS-2-ST
时间窗: from day 0 to day 28 after vaccination
Occurrence of unsolicited adverse events (AE)
Occurrence of serious adverse events (SAE) associated with MVA-SARS-2-ST
时间窗: through study completion, an average of 5 month
Occurrence of serious adverse events (SAE)
Change from baseline of pulmonary function associated with MVA-SARS-2-ST
时间窗: day 0 and twice daily on days 1, 2, 3, 4, 5, 6, 7
Change from baseline of pulmonary function measured by peak flow as peak expiratory flow (PEF) frequently
Change of safety laboratory measures associated with MVA-SARS-2-S
时间窗: day 1, 3, 7, 14, 28, 56, 140
Change from baseline of safety laboratory measures
次要结局
- To evaluate immunogenicity of the candidate MVA-SARS-2-ST(day 14)