Vaccines Immunogenicity in Renal, Hepatic, Cardiac or Pulmonary Transplanted Children

NCT03180359 | Completed

• 2 other identifiers: 69HCL17_03542015-A00854-45
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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

Conditions

Transplantation

Keywords

solid transplant; grafted children; vaccine recommendation; immunization efficacy; solid grafted children; solid transplant candidate children

Outcome Measures

Primary Outcomes (4)

• 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)

  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)

  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)

  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)

  3-month post-transplantation (if transplantation occurs during the study)

Secondary Outcomes (16)

• 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

• 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 0,

Study Arms (1)

Patient already transplanted or waiting for a transplantation

EXPERIMENTAL

Biological: Recommended vaccine scheme according to French Vaccine Schedule 2015

Interventions

Recommended vaccine scheme according to French Vaccine Schedule 2015 BIOLOGICAL

* 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

Patient already transplanted or waiting for a transplantation

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon

Bron, 69500, France

Location

Study Officials

• Laure HEES, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 8, 2017
• Study Start: January 1, 2016
• Primary Completion: October 13, 2019
• Study Completion: October 13, 2019
• Last Updated: March 8, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)