The Immunogenicity of Intradermal Influenza Vaccination in Hemodialysis Patients

Phase 2

Completed

• Conditions: Hemodialysis Patients
• Interventions: Biological: intradermal influenza vaccine; Biological: intramuscular influenza vaccine

• Registration Number: NCT01273974
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

The purpose of this study is to determine whether half-dose intradermal influenza vaccine is as immunogenic as standard dose intramuscular vaccine in hemodialysis patients.

Detailed Description

Hemodialysis patients are at high risk of influenza infection due to suppress immune status.It is recommended to immunize them against influenza annually.in intradermal vaccination antigens directly present to the large numbers of antigen-presenting cells in the skin and it may cause greater immunogenicity than in the intramuscular method. Reduced-dose intradermal influenza vaccine is immunogenic in healthy adult, patients with solid cancer and three groups of immunocompromized patients including Rheumatologic patients treated with anti-TNF, HIV-infected and stem cell transplanted patients.

In this study we compare the efficacy of influenza vaccines in half dose intradermal and standard intramuscular methods among hemodialysis patients.

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2009-11
• Study Completion: 2010-02
• Status Verified: 2010-08
• Study First Submitted: 2011-01-10
• Study First Submitted QC: 2011-01-10
• Last Update Submitted: 2011-01-10
• Study First Posted: 2011-01-11
• Last Update Posted: 2011-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Patients under chronic hemodialysis

Exclusion Criteria

• history of flu infection in last month
• history of flu vaccination in 2009
• hospitalization in last month
• taking immune suppressants drugs
• hemodialysis less than twice weekly

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intradermal influenza vaccine	intradermal influenza vaccine	-
intramuscular influenza vaccine	intramuscular influenza vaccine	-

Primary Outcome Measures

Name	Time	Method
vaccine effectiveness	3 months	serum antibody response measured by ELIZA method time frame:1 and 3 months after vaccination

Trial Locations

Locations (1)

Shiraz University Of Medical Science; 🇮🇷 Shiraz, Iran, Islamic Republic of