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The aim of this study is to improve the humoral immune response efficiency of hemodialyzed patient by the use of PMMA membrane (BK-F) able to clear the soluble form of CD40 in a model of anti-HBV vaccination
Chronic renal failure is associated with humoral immune alterations characterized by a diminished vaccine response notably against hepatitis B virus (HBV). Defects in cellular contact between immunological cells have been hypothesized to explain this observation but the precise mechanism leading to this "immunocompromised" status is not clear. The soluble form of CD40 (sCD40) is dramatically increased in the serum of uremic patients, particularly in the hemodialyzed patients. This molecule acts like an inhibitor of the CD40/CD154 contact, which is pivotal in the establishment of a proper humoral immune response. It has been shown that the most elevated sCD40 levels are associated with a lack of response to HBV vaccination in the hemodialyzed patients. The majority of the hemodialysis membranes, including high flux polysulfone membranes are unable to clear sCD40 from the sera. However, we found that the high flux polymethylmetacrylate (PMMA) membrane (BK-F Toray Medical Company, Japan) allows for sCD40 clearing.
The aim of this study is to assess the effect of dialysis on PMMA membrane on the improvement of humoral immune response through the efficiency of HBV vaccination in hemodialysed patients who were non responders to one ore more previous vaccination and its link to sCD40 clearing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High flux polymethylmetacrylate membrane | Experimental |
| |
| Polysulfone membranes | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High flux polymethylmetacrylate membrane | Procedure | Patients will be hemodialysed with high flux polymethylmetacrylate membranes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients who will respond to vaccination | Week 40 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage and the level of anti-HBs antibodies | at week 16, week 20, week 24 and week 40 | |
| Correlation between the sCD40 levels and the response to HBV vaccination | At week 12 and week 40 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Valérie de PRECIGOUT, MD | University Hospital, Bordeaux, France | Principal Investigator |
| Pierre BORIES, MD | University Hospital, Toulouse, France | Principal Investigator |
| Michel RINCE, MD | University Hospital, Limoges, France | Principal Investigator |
| Caroline DELCLAUX, MD | Hospital, Libourne, France | Principal Investigator |
| Antoine POMMEREAU, MD | Clinic Saint-Augustin, Bordeaux, France | Principal Investigator |
| Benjamin DEROURE, MD | Clinic Delay, Bayonne, France | Principal Investigator |
| Hervé BONAREK, MD | Hospital, Saintes, France | Principal Investigator |
| Antoine BENARD, MD | University Hospital, Bordeaux, France | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Annonay | Annonay | France | ||||
| CH de la cĂ´te Basque |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31722332 | Derived | de Precigout V, Germain C, Benard A, Lacraz A, Chauveau P, Deprele C, Seigneuric B, Pommereau A, Courivaud C, Douillet M, Taton B, Combe C, Contin-Bordes C. No Improvement of Hepatitis B Vaccination Response in Patients Dialysed with a Polymethylmethacrylate Membrane Compared to High-Flux Polysulfone: Results of the HEPADIAL Study. Blood Purif. 2020;49(3):265-271. doi: 10.1159/000504035. Epub 2019 Nov 13. |
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| Polysulfone membrane | Procedure | Patients be hemodialysed with polysulfone membranes |
|
| Hepatitis B serological control | Biological | It will be assessed at week 16, week 20 and week 40 |
|
| Seric sCD40 level | Biological | Ir will be measured at inclusion and week 12 by ELISA test according to the manufacturer instructions. |
|
| Correlation between albuminemia, C-Reactive Protein, lymphocytes, parathyroid hormone, chronic immunosuppressive treatment or corticoid taking and vaccinal response. |
| at week 12, week 24, and week 36 |
| Bayonne |
| 64100 |
| France |
| CHU de Besançon | Besançon | 25000 | France |
| Saint-Augustin Clinic, Dialyze Unit | Bordeaux | 33000 | France |
| Pellegrin Hospital, Nephrology Unit | Bordeaux | 33076 | France |
| Larrey Hospital, Dialyze Unit | Toulouse | 31059 | France |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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