Clinical trial NCT03180359: Vaccines Immunogenicity in Renal, Hepatic, Cardiac or Pulmonary Transplanted Children
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transplantation
Keywords: solid transplant
grafted children
vaccine recommendation
immunization efficacy
solid grafted children
solid transplant candidate children
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-06-08
Enrollment: 55
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* adults
* children or adolescent not able not comply with protocol
* children, adolescent or patient parents or legal guardian not opposed to study participation

Primary outcomes:
measure: Immunogenicity of vaccines recommended in children transplanted or candidate for renal, hepatic, cardiac and pulmonary transplantation
timeFrame: at Month 0
measure: Immunogenicity of vaccines recommended in children transplanted or candidate for renal, hepatic, cardiac and pulmonary transplantation
timeFrame: between Month 1 and Month 3
measure: Immunogenicity of vaccines recommended in children transplanted or candidate for renal, hepatic, cardiac and pulmonary transplantation
timeFrame: Month 12
measure: Immunogenicity of vaccines recommended in children transplanted or candidate for renal, hepatic, cardiac and pulmonary transplantation
timeFrame: 3-month post-transplantation (if transplantation occurs during the study)
Secondary outcomes:
measure: Levels of blood antibodies corresponding to the following vaccine valencies: influenza, pneumococcus, chicken pox (varicella), measles, tetanus, hepatitis A and hepatitis B.
timeFrame: at Month 0
measure: Levels of blood antibodies corresponding to the following vaccine valencies: influenza, pneumococcus, chicken pox (varicella), measles, tetanus, hepatitis A and hepatitis B.
timeFrame: between Month 1 and Month 3
measure: Levels of blood antibodies corresponding to the following vaccine valencies: influenza, pneumococcus, chicken pox (varicella), measles, tetanus, hepatitis A and hepatitis B.
timeFrame: at Month 12
measure: Levels of blood antibodies corresponding to the following vaccine valencies: influenza, pneumococcus, chicken pox (varicella), measles, tetanus, hepatitis A and hepatitis B.
timeFrame: 3-month post-transplantation (if transplantation occurs during the study)
measure: the number of early or late injections
timeFrame: at Month 0,
measure: the number of missing injections and supplementary injections
timeFrame: at Month 0,
measure: the number of days in advance or delayed from recommended injections (per injection and cumulative)
timeFrame: at Month 0,
measure: the number of early or late injections
timeFrame: between Month 1 and Month 3
measure: the number of missing injections and supplementary injections
timeFrame: between Month 1 and Month 3
measure: the number of days in advance or delayed from recommended injections (per injection and cumulative)
timeFrame: between Month 1 and Month 3
measure: the number of early or late injections
timeFrame: at Month 12
measure: the number of missing injections and supplementary injections
timeFrame: at Month 12
measure: the number of days in advance or delayed from recommended injections (per injection and cumulative)
timeFrame: at Month 12
measure: Vaccination coverage of patients' entourage
timeFrame: at month 0
measure: Patients' vaccine tolerance
timeFrame: at Week 1
measure: Patients' vaccine tolerance
timeFrame: at Month 1 after injection
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Laure HEES, MD
role: PRINCIPAL_INVESTIGATOR
References: