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

July 25, 2018 updated by: Hospices Civils de Lyon

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
341

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Bron, France, 69500
        • Recruiting
        • Hospices Civils de Lyon
        • Contact:
        • Contact:
        • Principal Investigator:
          • Laure HEES, MD
        • Sub-Investigator:
          • Yves GILLET, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patient already transplanted or waiting for a transplantation
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
at Month 0
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)
between Month 1 and Month 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)
Month 12
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)
3-month post-transplantation (if transplantation occurs during the study)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
at Month 0
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
between Month 1 and Month 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
at Month 12
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)
3-month post-transplantation (if transplantation occurs during the study)
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.
at Month 0,
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.
at Month 0,
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.
at Month 0,
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.
between Month 1 and Month 3
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.
between Month 1 and Month 3
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.
between Month 1 and Month 3
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.
at Month 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.
at Month 12
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.
at Month 12
Vaccination coverage of patients' entourage
Time Frame: at month 0
Number of missing, additional, early or late injections, compared to vaccine recommendations.
at month 0
Patients' vaccine tolerance
Time Frame: at Week 1
Local reactions, fever, clinical or biological signs of rejection
at Week 1
Patients' vaccine tolerance
Time Frame: at Month 1 after injection
Local reactions, fever, clinical or biological signs of rejection
at Month 1 after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Laure HEES, MD, Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 69HCL17_0354
  • 2015-A00854-45 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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