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

NCT03180359 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2023-03-08

No results posted yet for this study

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

Interventions

BIOLOGICAL

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

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Laure HEES, MD · Hospices Civils de Lyon

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-01
Primary Completion
2019-10-13
Completion
2019-10-13

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03180359 on ClinicalTrials.gov