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In 2009, the pandemic influenza A/H1N1 accounted for worldwide recommendations about vaccination. There is no data concerning the immunogenicity nor the security of the adjuvanted-A/H1N1 vaccine in renal disease patients. The aim of this study is to observe the effects of this vaccine on transplanted and hemodialyzed patients.
The serologic responses to the Pandemrix vaccine will assess the efficacy, with the determination of the seroconversion rate among the patients.
The anti-HLA and anti-MICA antibodies will be determined to assess the safety among the renal transplanted patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| influenza vaccine | Experimental | Pandemrix vaccine (Influenza A/H1N1 2009)to be injected to renal transplant patients, haemodialyzed patients, and controls |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza A/H1N1 2009-AS03 adjuvanted (Pandemrix) | Biological | intramuscular injection of 1 dose vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| to determine the efficacy aand safety of influenza A/H1N1 adjuvanted-vaccination among renal transplant and haemodialyzed patients as compared to controls | measures of anti-A/H1N1 antibodies with a method of microneutralizing test (seroneutralization) to follow-up the secondary effects of the vaccine and follow-up of renal function in renal transplanted patients. | one month post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| to controls and to assess the safety of the vaccine among renal transplanted patients by studying HLA or MICA sensitization before and following vaccination | To measure the Anti-HLA and anti-MICA antibodies with luminex-test | follow-up 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Abramowicz, PhD | Hospital Erasme | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Erasme | Brussels | Brabant | 1070 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19656126 | Background | Candon S, Thervet E, Lebon P, Suberbielle C, Zuber J, Lima C, Charron D, Legendre C, Chatenoud L. Humoral and cellular immune responses after influenza vaccination in kidney transplant recipients. Am J Transplant. 2009 Oct;9(10):2346-54. doi: 10.1111/j.1600-6143.2009.02787.x. Epub 2009 Jul 28. |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D012059 | Rejection, Psychology |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C556153 | pandemrix |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D012919 | Social Behavior |
| D001519 | Behavior |