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Influenza A/H1N1/2009-adjuvanted Vaccine in Renal Disease Patients

Primary Purpose

Decreased Immunologic Activity [PE], Influenza, Rejection

Status

Completed

Phase

Phase 4

Locations

Belgium

Study Type

Interventional

Intervention

Influenza A/H1N1 2009-AS03 adjuvanted (Pandemrix)

About this trial

This is an interventional prevention trial for Decreased Immunologic Activity [PE] focused on measuring kidney, transplantation, haemodialysis, vaccination, influenza H1N1 2009

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Adult patients
Haemodialyzed patients
Renal transplant recipients who have stable renal function for the last 3 months

Exclusion Criteria:

No pneumonia or severe infection during 1 month before vaccination
No Ivig (intravenous immunoglobulins) treatment during the last 3 months

Sites / Locations

Hospital Erasme

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

influenza vaccine

Arm Description

Pandemrix vaccine (Influenza A/H1N1 2009)to be injected to renal transplant patients, haemodialyzed patients, and controls

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01298102

First Posted

February 16, 2011

Last Updated

February 16, 2011

Sponsor

Erasme University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01298102

Brief Title

Influenza A/H1N1/2009-adjuvanted Vaccine in Renal Disease Patients

Official Title

Safety and Efficacy of Influenza A/H1N1/2009-adjuvanted Vaccine in Renal Transplant and Dialyzed Patients: a Prospective Cohort Study.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2010

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Erasme University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Decreased Immunologic Activity [PE], Influenza, Rejection

Keywords

kidney, transplantation, haemodialysis, vaccination, influenza H1N1 2009

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

185 (Actual)

8. Arms, Groups, and Interventions

Arm Title

influenza vaccine

Arm Type

Experimental

Arm Description

Pandemrix vaccine (Influenza A/H1N1 2009)to be injected to renal transplant patients, haemodialyzed patients, and controls

Intervention Type

Biological

Intervention Name(s)

Influenza A/H1N1 2009-AS03 adjuvanted (Pandemrix)

Other Intervention Name(s)

Pandemrix

Intervention Description

intramuscular injection of 1 dose vaccine

Primary Outcome Measure Information:

Title

to determine the efficacy aand safety of influenza A/H1N1 adjuvanted-vaccination among renal transplant and haemodialyzed patients as compared to controls

Description

Time Frame

one month post-vaccination

Secondary Outcome Measure Information:

Title

to controls and to assess the safety of the vaccine among renal transplanted patients by studying HLA or MICA sensitization before and following vaccination

Description

To measure the Anti-HLA and anti-MICA antibodies with luminex-test

Time Frame

follow-up 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult patients Haemodialyzed patients Renal transplant recipients who have stable renal function for the last 3 months Exclusion Criteria: No pneumonia or severe infection during 1 month before vaccination No Ivig (intravenous immunoglobulins) treatment during the last 3 months

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel Abramowicz, PhD

Organizational Affiliation

Hospital Erasme

Official's Role

Study Director

Facility Information:

Facility Name

Hospital Erasme

City

Brussels

State/Province

Brabant

ZIP/Postal Code

1070

Country

Belgium

12. IPD Sharing Statement

Citations:

PubMed Identifier

19656126

Citation

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.

Results Reference

background

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Influenza A/H1N1/2009-adjuvanted Vaccine in Renal Disease Patients

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