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

Phase 4

Completed

• Conditions: Decreased Immunologic Activity [PE]; Influenza; Rejection
• Interventions: Biological: Influenza A/H1N1 2009-AS03 adjuvanted (Pandemrix)

• Registration Number: NCT01298102
• Lead Sponsor: Erasme University Hospital

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.

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2010-06
• Study First Submitted: 2011-02-16
• Study First Submitted QC: 2011-02-16
• Last Update Submitted: 2011-02-16
• Study First Posted: 2011-02-17
• Last Update Posted: 2011-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
influenza vaccine	Influenza A/H1N1 2009-AS03 adjuvanted (Pandemrix)	Pandemrix vaccine (Influenza A/H1N1 2009)to be injected to renal transplant patients, haemodialyzed patients, and controls

Primary Outcome Measures

Name	Time	Method
to determine the efficacy aand safety of influenza A/H1N1 adjuvanted-vaccination among renal transplant and haemodialyzed patients as compared to controls	one month post-vaccination	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

Name	Time	Method
to controls and to assess the safety of the vaccine among renal transplanted patients by studying HLA or MICA sensitization before and following vaccination	follow-up 6 months	To measure the Anti-HLA and anti-MICA antibodies with luminex-test

Trial Locations

Locations (1)

Hospital Erasme; 🇧🇪 Brussels, Brabant, Belgium