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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
55
* BCG * Measles mumps rubella (MMR) * Varicella (chicken pox) * Rotavirus * Seasonal flu (live vaccine delivered nasally and inactivated vaccine injectable) * Yellow Fever * Diphteria tetanus poliomyelitis whopping cough (DTwP) * Haemophilus influenzae type b * Hepatitis B * Meningococcus conjugate * Pneumococcus * Human papillomavirus * Hepatitis A Vaccine administration would be done according to French Vaccine Schedule 2015 for mainstream population and for grafted children or transplant candidate children
Hospices Civils de Lyon
Bron, France
Immunogenicity of vaccines recommended in children transplanted or candidate for renal, hepatic, cardiac and pulmonary transplantation
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)
Time frame: at Month 0
Immunogenicity of vaccines recommended in children transplanted or candidate for renal, hepatic, cardiac and pulmonary transplantation
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)
Time frame: between Month 1 and Month 3
Immunogenicity of vaccines recommended in children transplanted or candidate for renal, hepatic, cardiac and pulmonary transplantation
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)
Time frame: Month 12
Immunogenicity of vaccines recommended in children transplanted or candidate for renal, hepatic, cardiac and pulmonary transplantation
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)
Time frame: 3-month post-transplantation (if transplantation occurs during the study)
Levels of blood antibodies corresponding to the following vaccine valencies: influenza, pneumococcus, chicken pox (varicella), measles, tetanus, hepatitis A and hepatitis B.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3-month post-transplantation (if transplantation occurs during the study)
the number of early or late injections
Vaccine status compliance with vaccine recommendation, from literature data and from the opinion of the Vaccine Technical Committee President. Compliance will be appraised by considering for each valence: * the number of early or late injections * the number of missing injections and supplementary injections * the number of days in advance or delayed from recommended injections (per injection and cumulative) 2 age groups will be differentiate : \<2 years (primary vaccination) and \>2 years For each age group, early or late injections are defined by considering literature data and the opinion of the Vaccine Technical Committee President.
Time frame: at Month 0,
the number of missing injections and supplementary injections
Vaccine status compliance with vaccine recommendation, from literature data and from the opinion of the Vaccine Technical Committee President. Compliance will be appraised by considering for each valence: * the number of early or late injections * the number of missing injections and supplementary injections * the number of days in advance or delayed from recommended injections (per injection and cumulative) 2 age groups will be differentiate : \<2 years (primary vaccination) and \>2 years For each age group, early or late injections are defined by considering literature data and the opinion of the Vaccine Technical Committee President.
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Time frame: at Month 0,
the number of days in advance or delayed from recommended injections (per injection and cumulative)
Vaccine status compliance with vaccine recommendation, from literature data and from the opinion of the Vaccine Technical Committee President. Compliance will be appraised by considering for each valence: * the number of early or late injections * the number of missing injections and supplementary injections * the number of days in advance or delayed from recommended injections (per injection and cumulative) 2 age groups will be differentiate : \<2 years (primary vaccination) and \>2 years For each age group, early or late injections are defined by considering literature data and the opinion of the Vaccine Technical Committee President.
Time frame: at Month 0,
the number of early or late injections
Vaccine status compliance with vaccine recommendation, from literature data and from the opinion of the Vaccine Technical Committee President. Compliance will be appraised by considering for each valence: * the number of early or late injections * the number of missing injections and supplementary injections * the number of days in advance or delayed from recommended injections (per injection and cumulative) 2 age groups will be differentiate : \<2 years (primary vaccination) and \>2 years For each age group, early or late injections are defined by considering literature data and the opinion of the Vaccine Technical Committee President.
Time frame: between Month 1 and Month 3
the number of missing injections and supplementary injections
Vaccine status compliance with vaccine recommendation, from literature data and from the opinion of the Vaccine Technical Committee President. Compliance will be appraised by considering for each valence: * the number of early or late injections * the number of missing injections and supplementary injections * the number of days in advance or delayed from recommended injections (per injection and cumulative) 2 age groups will be differentiate : \<2 years (primary vaccination) and \>2 years For each age group, early or late injections are defined by considering literature data and the opinion of the Vaccine Technical Committee President.
Time frame: between Month 1 and Month 3
the number of days in advance or delayed from recommended injections (per injection and cumulative)
Vaccine status compliance with vaccine recommendation, from literature data and from the opinion of the Vaccine Technical Committee President. Compliance will be appraised by considering for each valence: * the number of early or late injections * the number of missing injections and supplementary injections * the number of days in advance or delayed from recommended injections (per injection and cumulative) 2 age groups will be differentiate : \<2 years (primary vaccination) and \>2 years For each age group, early or late injections are defined by considering literature data and the opinion of the Vaccine Technical Committee President.
Time frame: between Month 1 and Month 3
the number of early or late injections
Vaccine status compliance with vaccine recommendation, from literature data and from the opinion of the Vaccine Technical Committee President. Compliance will be appraised by considering for each valence: * the number of early or late injections * the number of missing injections and supplementary injections * the number of days in advance or delayed from recommended injections (per injection and cumulative) 2 age groups will be differentiate : \<2 years (primary vaccination) and \>2 years For each age group, early or late injections are defined by considering literature data and the opinion of the Vaccine Technical Committee President.
Time frame: at Month 12
the number of missing injections and supplementary injections
Vaccine status compliance with vaccine recommendation, from literature data and from the opinion of the Vaccine Technical Committee President. Compliance will be appraised by considering for each valence: * the number of early or late injections * the number of missing injections and supplementary injections * the number of days in advance or delayed from recommended injections (per injection and cumulative) 2 age groups will be differentiate : \<2 years (primary vaccination) and \>2 years For each age group, early or late injections are defined by considering literature data and the opinion of the Vaccine Technical Committee President.
Time frame: at Month 12
the number of days in advance or delayed from recommended injections (per injection and cumulative)
Vaccine status compliance with vaccine recommendation, from literature data and from the opinion of the Vaccine Technical Committee President. Compliance will be appraised by considering for each valence: * the number of early or late injections * the number of missing injections and supplementary injections * the number of days in advance or delayed from recommended injections (per injection and cumulative) 2 age groups will be differentiate : \<2 years (primary vaccination) and \>2 years For each age group, early or late injections are defined by considering literature data and the opinion of the Vaccine Technical Committee President.
Time frame: at Month 12
Vaccination coverage of patients' entourage
Number of missing, additional, early or late injections, compared to vaccine recommendations.
Time frame: at month 0
Patients' vaccine tolerance
Local reactions, fever, clinical or biological signs of rejection
Time frame: at Week 1
Patients' vaccine tolerance
Local reactions, fever, clinical or biological signs of rejection
Time frame: at Month 1 after injection