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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01298102
• Other study ID #: Etude 2009/INT044
• Status: Completed
• Phase: Phase 4
• First received: February 16, 2011
• Last updated: February 16, 2011
• Start date: October 2009
• Est. completion date: March 2010

Study information

• Verified date: June 2010
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Decreased Immunologic Activity [PE]
• Influenza
• Influenza, Human
• Rejection

Intervention

Biological:
• Influenza A/H1N1 2009-AS03 adjuvanted (Pandemrix)
intramuscular injection of 1 dose vaccine

Locations

Country	Name	City	State
Belgium	Hospital Erasme	Brussels	Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes