A Partially Randomized, Partly Placebo Controlled Phase I Trial to Evaluate the Safety, Tolerability and Immunogenicity of the Recombinant MVA-BN® RSV Vaccine After Intranasal and Intramuscular Administration
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Occurrence of serious adverse events
研究概览
简要总结
A total of 96 subjects will be recruited into 5 groups. Each subject will receive either two vaccinations with MVA-BN-RSV vaccine or placebo.
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
- Single (Participant)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •signed and dated an informed consent form and HIPAA.
- •Subjects without symptomatic cardiopulmonary and/or metabolic disease.
- •Body mass index (BMI) ≥ 18.5 and ≤ 34.
- •Negative human immunodeficiency virus antibody test (anti-HIV), HBsAG and HCV virus.
- •Electrocardiogram (ECG) without clinically significant acute findings.
- •WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to each vaccination.
排除标准
- •History of nasal or sinus surgery within six months prior to screening or planned nasal or sinus surgery during the trial
- •Active or recent history (within 6 months prior to screening) of chronic sinusitis, nasopharyngeal abnormalities and/or symptoms such as polyps or deviated septum
- •pregnant or breast-feeding women.
- •History or current clinical manifestation of any serious medical condition.
- •History of or active autoimmune disease.
- •Known or suspected impairment of immunologic functions including, but not limited to chronic inflammatory bowel disorders, diabetes mellitus type I.
- •Knowledge/history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •History of anaphylaxis or severe allergic reaction to any vaccine.
- •Chronic systemic administration defined as more than 14 days of > 5 mg prednisone per day
研究组 & 干预措施
Group 5
≥55 year old healthy subjects, receiving 5x10E8 TCID50 MVA-BN-RSV intramuscular application
干预措施: MVA-BN-RSV (Biological)
Group 2
≥55 year old healthy subjects, receiving either 1x10E8 TCID50 MVA-BN-RSV or Placebo intranasal application
干预措施: MVA-BN-RSV (Biological)
Group 3
≥55 year old healthy subjects, receiving either 5x10E8 TCID50 MVA-BN-RSV or Placebo intranasal application
干预措施: MVA-BN-RSV (Biological)
Group 1
≥55 year old healthy subjects, receiving either 5x10E7 TCID50 MVA-BN-RSV or Placebo intranasal application
干预措施: Placebo (Other)
Group 2
≥55 year old healthy subjects, receiving either 1x10E8 TCID50 MVA-BN-RSV or Placebo intranasal application
干预措施: Placebo (Other)
Group 3
≥55 year old healthy subjects, receiving either 5x10E8 TCID50 MVA-BN-RSV or Placebo intranasal application
干预措施: Placebo (Other)
Group 4
≥55 year old healthy subjects, receiving 5x10E8 TCID50 MVA-BN-RSV intranasal and intramuscular application
干预措施: MVA-BN-RSV (Biological)
Group 1
≥55 year old healthy subjects, receiving either 5x10E7 TCID50 MVA-BN-RSV or Placebo intranasal application
干预措施: MVA-BN-RSV (Biological)
结局指标
主要结局
Occurrence of serious adverse events
时间窗: Screening up to week 34 after first vaccination
Occurrence, relationship to the trial vaccine and intensity of any serious adverse event (SAE).
次要结局
- RSV-specific humoral immune response(humoral immune response is measured up to week 34)