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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A00854-45 | Other Identifier | ID-RCB |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient already transplanted or waiting for a transplantation | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recommended vaccine scheme according to French Vaccine Schedule 2015 | Biological |
Vaccine administration would be done according to French Vaccine Schedule 2015 for mainstream population and for grafted children or transplant candidate children |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of vaccines recommended in children transplanted or candidate for renal, hepatic, cardiac and pulmonary transplantation | 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 | 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 | 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 |
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laure HEES, MD | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils de Lyon | Bron | 69500 | France |
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| Immunogenicity of vaccines recommended in children transplanted or candidate for renal, hepatic, cardiac and pulmonary transplantation | 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) |
| 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. | 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. | 3-month post-transplantation (if transplantation occurs during the study) |
| the number of early or late injections | 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:
| at Month 0, |
| the number of missing injections and supplementary injections | 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:
| at Month 0, |
| the number of days in advance or delayed from recommended injections (per injection and cumulative) | 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:
| at Month 0, |
| the number of early or late injections | 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:
| between Month 1 and Month 3 |
| the number of missing injections and supplementary injections | 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:
| between Month 1 and Month 3 |
| the number of days in advance or delayed from recommended injections (per injection and cumulative) | 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:
| between Month 1 and Month 3 |
| the number of early or late injections | 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:
| at Month 12 |
| the number of missing injections and supplementary injections | 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:
| at Month 12 |
| the number of days in advance or delayed from recommended injections (per injection and cumulative) | 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:
| at Month 12 |
| Vaccination coverage of patients' entourage | Number of missing, additional, early or late injections, compared to vaccine recommendations. | at month 0 |
| Patients' vaccine tolerance | Local reactions, fever, clinical or biological signs of rejection | at Week 1 |
| Patients' vaccine tolerance | Local reactions, fever, clinical or biological signs of rejection | at Month 1 after injection |