Vaccines Immunogenicity in Children Transplanted or Candidate for a Renal, Hepatic, Cardiac or Pulmonary Transplantation, Followed in the Rhône-Alpes Region. A Descriptive and Prospective Monocentric Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Immunogenicity of vaccines recommended in children transplanted or candidate for renal, hepatic, cardiac and pulmonary transplantation
研究概览
简要总结
Thanks to improved surgical techniques, postoperative management and immunosuppressive therapies, an increasing number of children benefit from renal, hepatic, cardiac and pulmonary transplantation. Infection is a significant cause of mortality and morbidity in these patients, particularly due to vaccine-preventable diseases. Vaccination is one of the effective means of reducing infection-related mortality in these particularly vulnerable children. It is mostly well-tolerated, but all the more effective as it is performed early before transplantation, at best during a dedicated consultation, according to a vaccine scheme adapted to the immunocompromised child. In the almost constant absence of clinical efficacy data in populations of immunocompromised individuals, vaccine efficacy is most often indirectly estimated by immunogenicity, using protective correlates obtained by extrapolation in immunocompetent individuals.
Primary objective: To estimate the immunogenicity of vaccines recommended in children transplanted or candidate for renal, hepatic, cardiac and pulmonary transplantation, using serological titers measurements before and after a vaccine injection for: influenza, pneumococcus, chicken pox, measles, tetanus, hepatitis A and hepatitis B.
These serological titers will be compared to correlates of protection existing for each valency.
The evolution of serological titers will be described during the first year. The vaccination will be carried out within the routine care, according to the recommendations.
Secondary objectives:
- describe and quantify the vaccination status of patients
- describe the vaccination coverage of their entourage
- evaluate the tolerance and efficacy of vaccines
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children and adolescent between 0 and 17 years old
- •registered in the database of the Agency of Biomedicine
- •transplanted or waiting for a renal, hepatic, cardiac or pulmonary transplantation
- •followed up in the Rhône-Alpes region between January 1st , 2015 and December 31th, 2016
- •patients requiring vaccination in standard care
排除标准
- •children or adolescent not able not comply with protocol
- •children, adolescent or patient parents or legal guardian not opposed to study participation
研究组 & 干预措施
Patient already transplanted or waiting for a transplantation
干预措施: Recommended vaccine scheme according to French Vaccine Schedule 2015 (Biological)
结局指标
主要结局
Immunogenicity of vaccines recommended in children transplanted or candidate for renal, hepatic, cardiac and pulmonary transplantation
时间窗: 3-month post-transplantation (if transplantation occurs during the study)
The immunogenicity is appraised from serological titer before and after vaccine injection. These serological titers will be compared to existing reference protection correlates for each valency, and defined as protective or non-protective: Tetanus (\>0,1 UI/ml), hepatitis B (\>10 mUI/ml), hepatitis A (\> 20 mUI/ml), measles (0,18 in EIA index), chicken pox (\> 5 gp Elisa UI/ml or \> 50 UI/l with an highly sensitive test), influenza (Hemagglutination Inhibition Assay \> 1/40), pneumococcus (0,35 µg/ml, \> 0,4 mg/l for each specific serotype, if \> 2/3 or 4/6, protecting serotype)
Immunogenicity of vaccines recommended in children transplanted or candidate for renal, hepatic, cardiac and pulmonary transplantation
时间窗: at Month 0
The immunogenicity is appraised from serological titer before and after vaccine injection. These serological titers will be compared to existing reference protection correlates for each valency, and defined as protective or non-protective: Tetanus (\>0,1 UI/ml), hepatitis B (\>10 mUI/ml), hepatitis A (\> 20 mUI/ml), measles (0,18 in EIA index), chicken pox (\> 5 gp Elisa UI/ml or \> 50 UI/l with an highly sensitive test), influenza (Hemagglutination Inhibition Assay \> 1/40), pneumococcus (0,35 µg/ml, \> 0,4 mg/l for each specific serotype, if \> 2/3 or 4/6, protecting serotype)
Immunogenicity of vaccines recommended in children transplanted or candidate for renal, hepatic, cardiac and pulmonary transplantation
时间窗: between Month 1 and Month 3
The immunogenicity is appraised from serological titer before and after vaccine injection. These serological titers will be compared to existing reference protection correlates for each valency, and defined as protective or non-protective: Tetanus (\>0,1 UI/ml), hepatitis B (\>10 mUI/ml), hepatitis A (\> 20 mUI/ml), measles (0,18 in EIA index), chicken pox (\> 5 gp Elisa UI/ml or \> 50 UI/l with an highly sensitive test), influenza (Hemagglutination Inhibition Assay \> 1/40), pneumococcus (0,35 µg/ml, \> 0,4 mg/l for each specific serotype, if \> 2/3 or 4/6, protecting serotype)
Immunogenicity of vaccines recommended in children transplanted or candidate for renal, hepatic, cardiac and pulmonary transplantation
时间窗: Month 12
The immunogenicity is appraised from serological titer before and after vaccine injection. These serological titers will be compared to existing reference protection correlates for each valency, and defined as protective or non-protective: Tetanus (\>0,1 UI/ml), hepatitis B (\>10 mUI/ml), hepatitis A (\> 20 mUI/ml), measles (0,18 in EIA index), chicken pox (\> 5 gp Elisa UI/ml or \> 50 UI/l with an highly sensitive test), influenza (Hemagglutination Inhibition Assay \> 1/40), pneumococcus (0,35 µg/ml, \> 0,4 mg/l for each specific serotype, if \> 2/3 or 4/6, protecting serotype)
次要结局
- Vaccination coverage of patients' entourage(at month 0)
- the number of missing injections and supplementary injections(at Month 12)
- the number of days in advance or delayed from recommended injections (per injection and cumulative)(at Month 12)
- Levels of blood antibodies corresponding to the following vaccine valencies: influenza, pneumococcus, chicken pox (varicella), measles, tetanus, hepatitis A and hepatitis B.(3-month post-transplantation (if transplantation occurs during the study))
- the number of early or late injections(at Month 12)
- Patients' vaccine tolerance(at Month 1 after injection)
- Levels of blood antibodies corresponding to the following vaccine valencies: influenza, pneumococcus, chicken pox (varicella), measles, tetanus, hepatitis A and hepatitis B.(at Month 0)
- Levels of blood antibodies corresponding to the following vaccine valencies: influenza, pneumococcus, chicken pox (varicella), measles, tetanus, hepatitis A and hepatitis B.(between Month 1 and Month 3)
- Levels of blood antibodies corresponding to the following vaccine valencies: influenza, pneumococcus, chicken pox (varicella), measles, tetanus, hepatitis A and hepatitis B.(at Month 12)
- the number of early or late injections(at Month 0,)
- the number of missing injections and supplementary injections(at Month 0,)
- the number of days in advance or delayed from recommended injections (per injection and cumulative)(at Month 0,)
- the number of early or late injections(between Month 1 and Month 3)
- the number of missing injections and supplementary injections(between Month 1 and Month 3)
- the number of days in advance or delayed from recommended injections (per injection and cumulative)(between Month 1 and Month 3)
- Patients' vaccine tolerance(at Week 1)