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

NCT ID: NCT03180359

Last Updated: 2023-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2019-10-13

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patient already transplanted or waiting for a transplantation

Group Type: EXPERIMENTAL

Recommended vaccine scheme according to French Vaccine Schedule 2015

Intervention Type: 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

Interventions

Recommended vaccine scheme according to French Vaccine Schedule 2015

• 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

Intervention Type: BIOLOGICAL

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

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laure HEES, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Hospices Civils de Lyon

Bron, , France

Countries

France

Other Identifiers

2015-A00854-45

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL17_0354

Identifier Type: -

Identifier Source: org_study_id