Vaccines Immunogenicity in Renal, Hepatic, Cardiac or Pulmonary Transplanted Children (COVAGREF)

Civil Hospices of Lyon

Status

Completed

Conditions

Transplantation

Treatments

Biological: Recommended vaccine scheme according to French Vaccine Schedule 2015

Study type

Interventional

Funder types

Other

Identifiers

NCT03180359

69HCL17_0354

2015-A00854-45 (Other Identifier)

Details and patient eligibility

About

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

Enrollment

55 patients

Sex

All

Ages

Under 17 years old

Volunteers

No Healthy Volunteers

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