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

Transplantation Clinical Trial

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

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03180359
Study type Interventional
Source Hospices Civils de Lyon
Contact
Status Completed
Phase N/A
Start date January 1, 2016
Completion date October 13, 2019
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