NCT02873286已完成2 期
A Randomized, Single-blind, Placebo Controlled, Dose-ranging Phase II Trial in ≥ 55 Year Old Adults to Evaluate the Safety and Immunogenicity of the Recombinant MVA-BN-RSV Vaccine
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 420
- 试验地点
- 22
- 主要终点
- PRNT (Subtype A) GMT
研究概览
简要总结
A total of 400 subjects will be recruited into five treatment subject groups à 80 subjects.Subject will receive two administrations 4 weeks apart which will consist of MVA-BN-RSV Dose 1, MVA-BN-RSV Dose 2 or Placebo (TBS).
86 subjects from 2 treatment groups (43 per treatment group) are supposed to receive one (booster) dose of MVA-BN-RSV vaccine approximately one year after their first vaccination. In this booster substudy, eligible subjects will receive the same dose they received during the main trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
PRNT (Subtype A) GMT
时间窗: Week 6 (Main Study) i.e., 2 weeks following the second vaccination
Geometric Mean Titers (GMTs) based on RSV-specific Plaque Reduction Neutralization Test (PRNT; against subtype A). Titers below the detection limit (DL) are included with a value of '10' (i.e. 1/2 DL)
次要结局
- Percentage of Participants With Response by PRNT (Subtype A)(within 108 weeks)
- PRNT (Subtype B) GMT(within 108 weeks)
- PRNT (Subtype A) GMT(within 108 weeks)
- ELISA (IgG) GMT(within 108 weeks)
- Percentage of Participants With Response by PRNT (Subtype B)(within 108 weeks)
- Percentage of Participants With Response by IgG ELISA(within 108 weeks)
- ELISA (IgA) GMT(within 108 weeks)
- Percentage of Participants With Response by IgA ELISA(within 108 weeks)
- ELISA (Mucosal IgA) GMT(within 82 weeks)
- Percentage of Participants With Response by Mucosal IgA ELISA(within 82 weeks)
- ELISPOT (IFN-g, Peptide Pool: F) GMSFU(within 58 weeks)
- ELISPOT (IFN-g, Peptide Pool: G(A)) GMSFU(within 58 weeks)
- ELISPOT (IFN-g, Peptide Pool: G(B)) GMSFU(within 58 weeks)
- ELISPOT (IFN-g, Peptide Pool: M2) GMSFU(within 58 weeks)
- ELISPOT (IL-4, Peptide Pool: F) GMSFU(within 58 weeks)
- ELISPOT (IL-4, Peptide Pool: G(A)) GMSFU(within 58 weeks)
- ELISPOT (IFN-g, Peptide Pool: N) GMSFU(within 58 weeks)
- ELISPOT (IL-4, Peptide Pool: G(B)) GMSFU(within 58 weeks)
- ELISPOT (IL-4, Peptide Pool: M2) GMSFU(within 58 weeks)
- Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: F)(within 58 weeks)
- Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(A))(within 58 weeks)
- Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: G(B))(within 58 weeks)
- Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: M2)(within 58 weeks)
- ELISPOT (IL-4, Peptide Pool: N) GMSFU(within 58 weeks)
- Percentage of Participants With Response by ELISPOT (IFN-g, Peptide Pool: N)(within 58 weeks)
- Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: F)(within 58 weeks)
- Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(A))(within 58 weeks)
- Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: G(B))(within 58 weeks)
- Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: M2)(within 58 weeks)
- Grade ≥ 3 Solicited General Adverse Events(within 8 days after vaccination)
- Related Solicited General Adverse Events(within 8 days after vaccination)
- Percentage of Participants With Response by ELISPOT (IL-4, Peptide Pool: N)(within 58 weeks)
- Memory B Cells (IgG) GMSFU(within 82 weeks)
- Serious Adverse Events(within 108 weeks (Main Study + Booster Substudy))
- Related Serious Adverse Events(within 108 weeks (Main Study + Booster Substudy))
- Grade ≥ 3 Serious Adverse Events(within 108 weeks (Main Study + Booster Substudy))
- Related Grade ≥ 3 Adverse Events(within 29 days after vaccination)
- Solicited Local Adverse Events(within 8 days after vaccination)
- Grade ≥ 3 Solicited Local Adverse Events(within 8 days after vaccination)
- Solicited General Adverse Events(within 8 days after vaccination)
- Unsolicited Non-serious Adverse Events(within 29 days after vaccination)
- Related Unsolicited Non-serious Adverse Events(within 29 days after vaccination)
- Grade ≥ 3 Unsolicited Non-serious Adverse Events(within 29 days after vaccination)
研究者
研究点 (22)
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