A Prospective Cohort Study of Efficacy, Safety and Characterization of Immune Response to Vaccinations in Hematopoietic Stem Cell Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- proportion of responders defined by the increase in specific antibody titers at 3 months after full block vaccination including tetanus, diphtheria, Pneumococcus, Haemophilus influenza type B (Hib), and hepatitis B virus (HBV).
研究概览
简要总结
Hematopoietic stem cell transplantation (HSCT) is a cellular therapy aiming at curing some hematological diseases. Upon transplantation, recipients experience a phase of profound immune suppression with loss of protective immunity against most infectious agents. Revaccination of HSCT recipients against vaccine-preventable infections is an important post-transplant intervention for reducing morbi-mortality. The VaccHemInf project aims at assessing the efficacy of recommended vaccines in adult recipients of HSCT, through the antibody titers reference method and a panel of immune functional assays.
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
- 是
入选标准
- •allogeneic and autologous HSCT recipients
- •≥ 18 year-old
- •patients having been informed of the conditions of the study (24-month follow-up) and having signed the informed consent form
- •Person with social security insurance
- •Additional inclusion criteria for healthy volunteers enrolled (10 volunteers)in the ancillary study of influenza vaccine response:
- •health-care workers recruited from the hospital staff
排除标准
- •Patient with innate or acquired immune deficiency (severe combined immunodeficiency, Hepatitis C virus (HCV), HBV, HIV infections at any stage)
- •Pregnant or breastfeeding women
- •History of previous severe allergic reaction to vaccine components
- •Patient with no social security coverage, with restricted liberty or under legal protection.
研究组 & 干预措施
hematopoietic stem cell transplant (HSCT)
immune biomarkers to evaluate vaccine response in HSCT recipients
干预措施: immune biomarkers to evaluate vaccine response in HSCT recipients (Biological)
结局指标
主要结局
proportion of responders defined by the increase in specific antibody titers at 3 months after full block vaccination including tetanus, diphtheria, Pneumococcus, Haemophilus influenza type B (Hib), and hepatitis B virus (HBV).
时间窗: at 3 months after block vaccination
ELISA methods will be used to measure serum level concentrations of specific immunoglobulin G (IgG) antibodies to tetanus toxoid, diphtheria toxoid, Hib, pneumococcal capsular polysaccharides and HBV. For pneumococcus, a 4-fold increase in the IgG titer will be considered significant for immunization. For Hib, the values between 0.15-1 μg/mL will be significant for immunization (linearity limit of 9 μg/mL). An IgG titer equal or higher than 0.1 IU/mL for diphtheria and tetanus and higher than 10 mIU/mL for HBV (anti-HBs antibody titer will be considered protective) . An anti-HBs titer higher than 100 IU/mL will be considered to confer long-lasting protection.
次要结局
- Correlation between innate immune response after ex vivo whole blood stimulation and vaccine response(before and at 3 months after full block vaccination)
- ancillary study of cellular and humoral response to one dose of tetravalent inactivated influenza vaccine (IIV)(4 weeks after influenza vaccination.)
- proportion of responders defined by the increase in specific antibody titers at 12 months after full block vaccination including tetanus, diphtheria, Pneumococcus, Haemophilus influenza type B (Hib), and hepatitis B virus (HBV).(at 12 months after block vaccination)
- proportion of responders defined by the increase in specific antibody titers at 24 months after full block vaccination including tetanus, diphtheria, Pneumococcus, Haemophilus influenza type B (Hib), and hepatitis B virus (HBV).(at 24 months after block vaccination)
- Correlation between quantification of relevant immune cells of HSCT recipients and vaccine response(at 3, 12 and 24 months after full block vaccination)
- proportion of HSCT recipients with adverse event after each vaccination including local and general reactions(21 days after each vaccination)
- Correlation between proliferative T-cell response to mitogens and antigens and vaccine response(before and at 3 months after full block vaccination)