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OpenTrials
Completed

NCT Number: NCT03180359

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

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

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Key information

Conditions

Transplantation

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Immunogenicity of vaccines recommended in children transplanted or candidate for renal, hepatic, cardiac and pulmonary transplantation

    Time frame: at Month 0

    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)

  2. Immunogenicity of vaccines recommended in children transplanted or candidate for renal, hepatic, cardiac and pulmonary transplantation

    Time frame: between Month 1 and Month 3

    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. Immunogenicity of vaccines recommended in children transplanted or candidate for renal, hepatic, cardiac and pulmonary transplantation

    Time frame: Month 12

    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)

  4. Immunogenicity of vaccines recommended in children transplanted or candidate for renal, hepatic, cardiac and pulmonary transplantation

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

    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)

Secondary outcomes

  1. Levels of blood antibodies corresponding to the following vaccine valencies: influenza, pneumococcus, chicken pox (varicella), measles, tetanus, hepatitis A and hepatitis B.

    Time frame: at Month 0

  2. Levels of blood antibodies corresponding to the following vaccine valencies: influenza, pneumococcus, chicken pox (varicella), measles, tetanus, hepatitis A and hepatitis B.

    Time frame: between Month 1 and Month 3

  3. Levels of blood antibodies corresponding to the following vaccine valencies: influenza, pneumococcus, chicken pox (varicella), measles, tetanus, hepatitis A and hepatitis B.

    Time frame: at Month 12

  4. Levels of blood antibodies corresponding to the following vaccine valencies: influenza, pneumococcus, chicken pox (varicella), measles, tetanus, hepatitis A and hepatitis B.

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

  5. the number of early or late injections

    Time frame: at Month 0,

    Vaccine status compliance with vaccine recommendation, from literature data and from the opinion of the Vaccine Technical Committee President.

    Compliance will be appraised by considering for each valence:

    • the number of early or late injections
    • the number of missing injections and supplementary injections
    • the number of days in advance or delayed from recommended injections (per injection and cumulative) 2 age groups will be differentiate : <2 years (primary vaccination) and >2 years For each age group, early or late injections are defined by considering literature data and the opinion of the Vaccine Technical Committee President.

  6. the number of missing injections and supplementary injections

    Time frame: at Month 0,

    Vaccine status compliance with vaccine recommendation, from literature data and from the opinion of the Vaccine Technical Committee President.

    Compliance will be appraised by considering for each valence:

    • the number of early or late injections
    • the number of missing injections and supplementary injections
    • the number of days in advance or delayed from recommended injections (per injection and cumulative) 2 age groups will be differentiate : <2 years (primary vaccination) and >2 years For each age group, early or late injections are defined by considering literature data and the opinion of the Vaccine Technical Committee President.

  7. the number of days in advance or delayed from recommended injections (per injection and cumulative)

    Time frame: at Month 0,

    Vaccine status compliance with vaccine recommendation, from literature data and from the opinion of the Vaccine Technical Committee President.

    Compliance will be appraised by considering for each valence:

    • the number of early or late injections
    • the number of missing injections and supplementary injections
    • the number of days in advance or delayed from recommended injections (per injection and cumulative) 2 age groups will be differentiate : <2 years (primary vaccination) and >2 years For each age group, early or late injections are defined by considering literature data and the opinion of the Vaccine Technical Committee President.

  8. the number of early or late injections

    Time frame: between Month 1 and Month 3

    Vaccine status compliance with vaccine recommendation, from literature data and from the opinion of the Vaccine Technical Committee President.

    Compliance will be appraised by considering for each valence:

    • the number of early or late injections
    • the number of missing injections and supplementary injections
    • the number of days in advance or delayed from recommended injections (per injection and cumulative) 2 age groups will be differentiate : <2 years (primary vaccination) and >2 years For each age group, early or late injections are defined by considering literature data and the opinion of the Vaccine Technical Committee President.

  9. the number of missing injections and supplementary injections

    Time frame: between Month 1 and Month 3

    Vaccine status compliance with vaccine recommendation, from literature data and from the opinion of the Vaccine Technical Committee President.

    Compliance will be appraised by considering for each valence:

    • the number of early or late injections
    • the number of missing injections and supplementary injections
    • the number of days in advance or delayed from recommended injections (per injection and cumulative) 2 age groups will be differentiate : <2 years (primary vaccination) and >2 years For each age group, early or late injections are defined by considering literature data and the opinion of the Vaccine Technical Committee President.

  10. the number of days in advance or delayed from recommended injections (per injection and cumulative)

    Time frame: between Month 1 and Month 3

    Vaccine status compliance with vaccine recommendation, from literature data and from the opinion of the Vaccine Technical Committee President.

    Compliance will be appraised by considering for each valence:

    • the number of early or late injections
    • the number of missing injections and supplementary injections
    • the number of days in advance or delayed from recommended injections (per injection and cumulative) 2 age groups will be differentiate : <2 years (primary vaccination) and >2 years For each age group, early or late injections are defined by considering literature data and the opinion of the Vaccine Technical Committee President.

  11. the number of early or late injections

    Time frame: at Month 12

    Vaccine status compliance with vaccine recommendation, from literature data and from the opinion of the Vaccine Technical Committee President.

    Compliance will be appraised by considering for each valence:

    • the number of early or late injections
    • the number of missing injections and supplementary injections
    • the number of days in advance or delayed from recommended injections (per injection and cumulative) 2 age groups will be differentiate : <2 years (primary vaccination) and >2 years For each age group, early or late injections are defined by considering literature data and the opinion of the Vaccine Technical Committee President.

  12. the number of missing injections and supplementary injections

    Time frame: at Month 12

    Vaccine status compliance with vaccine recommendation, from literature data and from the opinion of the Vaccine Technical Committee President.

    Compliance will be appraised by considering for each valence:

    • the number of early or late injections
    • the number of missing injections and supplementary injections
    • the number of days in advance or delayed from recommended injections (per injection and cumulative) 2 age groups will be differentiate : <2 years (primary vaccination) and >2 years For each age group, early or late injections are defined by considering literature data and the opinion of the Vaccine Technical Committee President.

  13. the number of days in advance or delayed from recommended injections (per injection and cumulative)

    Time frame: at Month 12

    Vaccine status compliance with vaccine recommendation, from literature data and from the opinion of the Vaccine Technical Committee President.

    Compliance will be appraised by considering for each valence:

    • the number of early or late injections
    • the number of missing injections and supplementary injections
    • the number of days in advance or delayed from recommended injections (per injection and cumulative) 2 age groups will be differentiate : <2 years (primary vaccination) and >2 years For each age group, early or late injections are defined by considering literature data and the opinion of the Vaccine Technical Committee President.

  14. Vaccination coverage of patients' entourage

    Time frame: at month 0

    Number of missing, additional, early or late injections, compared to vaccine recommendations.

  15. Patients' vaccine tolerance

    Time frame: at Week 1

    Local reactions, fever, clinical or biological signs of rejection

  16. Patients' vaccine tolerance

    Time frame: at Month 1 after injection

    Local reactions, fever, clinical or biological signs of rejection

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study 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

Acronym: COVAGREF

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jun 8, 2017
Registry last updated
Mar 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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