A Phase-2b Controlled Study to Evaluate the Humoral and Cellular Immune Response and Safety Following One and Two Doses of an Adjuvanted RSV Subunit Vaccine in Immunocompromised Patients Aged 18 Years and Older.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- To assess the mean geometric increase of RSV-A and RSV-B neutralizing antibodies after second vaccine dose over first vaccine dose with the adjuvanted RSV subunit vaccine Arexvy in immunocompromised patients ≥ 18 YoA.
研究概览
简要总结
Respiratory syncytial Virus (RSV) causes respiratory infections worldwide and typically presents with a seasonal pattern peaking in autumn/winter in temperate climate zones. Apart from infants and elderly individuals, patients with underlying substantial respiratory, cardiovascular, endocrinological diseases and immunocompromised patients are at increased risk to develop lower respiratory tract infection (LRTI) requiring intensive care associated with increased mortality. For certain risk groups such as patients after hematologic stem cell transplantation (HSCT) in-hospital mortality may be as high as 70 %. A causally related, RSV specific treatment does not exist and treatment is therefore usually supportive and non-specific.
The study is aiming to determine if immunocompromised patients benefit from two doses of a RSV subunit vaccine as opposed to one dose. The additional dose will be administered off label.
详细描述
The aim of this study is to assess immunogenicity and safety of the adjuvanted RSV vaccine Arexvy in different cohorts of immunocompromised patients. These data are needed as a basis for RSV vaccine recommendations.
Currently, one dose of the RSV vaccine is recommended for the elderly (≥ 60 years) according to the SmPC and national recommendations. However, it is not clear yet, whether in immunocompromised patients such as those with solid tumors, hemato-oncological malignancies with and without hematopoietic stem cell transplantation (HSCT) or those with biological treatments one dose of RSV vaccine would be sufficient to induce immune responses or if these patients would benefit from a second dose.
It is planned to evaluate immune responses after one and two doses with the adjuvanted RSV vaccine Arexvy in immunocompromised study groups compared to responses of healthy, elderly individuals receiving one vaccine dose only. Our analysis plan will include humoral and cellular immune responses after the first and second dose in immunocompromised patients belonging to different study groups compared to responses after one vaccine dose in controls.
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)
盲法说明
Controls will be randomized in a 1:1 ratio before study intervention at V1 to receive Arexvy / saline.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group 1-3 (2 times verum)
Group 1-3 receive 2 doses of the RSV vaccine at visit 1 and visit 3, 1-2 months apart.
干预措施: Arexvy powder and suspension for injection (Biological)
Group 4 (1 time verum, 1 time placebo, randomised)
Group 4 receives 1 doses of the RSV vaccine or placebo at visit 1 and visit 3.
干预措施: Arexvy powder and suspension for injection (Biological)
结局指标
主要结局
To assess the mean geometric increase of RSV-A and RSV-B neutralizing antibodies after second vaccine dose over first vaccine dose with the adjuvanted RSV subunit vaccine Arexvy in immunocompromised patients ≥ 18 YoA.
时间窗: up to 14 months per participant
Fold increase of RSV-A and -B-specific neutralizing titers 30-60 days (V5) after the second dose relative to titers 30-60 days (V3) after the first dose in immunocompromised patients per group.
次要结局
未报告次要终点
研究者
Angelika Wagner
Principal Investigator
Medical University of Vienna