Prospective Study on the Vaccine Response to Meningococcal B Vaccine After Allogeneic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- % of patients with Bactericidal titers > 4 to at least one component of the Bexsero vaccine, 1 month after the 2nd dose.
研究概览
简要总结
Allogeneic hematopoietic stem cell transplant (HSCT) recipients are at risk of various bacterial infections, especially due to a progressive decrease of specific antibodies. Around 90% of HSCT recipients have unprotective titers of specific antibodies to serogroups A and C meningogocci (Parkkali 2001; Mahler 2012).
Some small studies suggest that the response to meningococcal A and C vaccines is close to 100% after 3 doses given 18 months after transplant. Although the response to 2 doses of 4CMenB is over 75% in other immunocompromised patients (Feavers, 2017), studies with 4CMenB are lacking after HSCT. Nevertheless, as serogroup B caused 74% of IMD in Europe between 2004-2014 (Whittaker, 2017), the meningococcal B vaccination is recommended by the more recent guidelines from 6 months after transplant. There are, however, no data on the safety and efficacy of this vaccine after hematopoietic stem cell allograft (HSCT).
The objective of this study is to assess the response to 2 doses of a multicomponent meningococcal B vaccine (4CMenB) given at 2 months interval in adult allogeneic HSCT recipients transplanted at least 6 months ago.
The response will be assessed 1 month and 10 months after the second dose of vaccine by measuring bactericidal antibodies against NadA, fHbp, NHBA and PorAP1 vaccinal antigens according to methods previously reported (Caron Lancet Infect Dis 2011). The response rate will be correlated to pre- and post-transplant factors.
The hypothesis of this study is that 80% of the patients should have protective titers one month after the 2nd dose.
详细描述
Monocentric study. Forty patients are expected.
Primary objective: Response rate one month after 2 doses of vaccine
Secondary objectives: safety, rate of protection before vaccination, comparison of the antibody titers at one month vs. at 10 months after the vaccine program. Relationship between pre and post-transplant factors.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Allogeneic HSCT at least 6 months before
- •Age ≥ 18 years
- •Platelet count > 50 G/L
排除标准
- •Rituximab administration in the previous 6 months
- •Relapse of the underlying disease
结局指标
主要结局
% of patients with Bactericidal titers > 4 to at least one component of the Bexsero vaccine, 1 month after the 2nd dose.
时间窗: 1 month
Vaccine response rate at one month after the 2nd dose.
次要结局
- % of patients with Bactericidal titers > 4 to at least one component of the Bexsero vaccine, 12 months after the 1st dose.(12 month)
- Number of adverse events of vaccination by Bexsero after Allograft of CSH.(12 month)