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Clinical Trials/NCT01273974
NCT01273974
Completed
Phase 2

The Comparison of Serum Antibody Response to Standard Intramuscular and Half Dose Intradermal Influenza Vaccine in Hemodialysis Patients in Shiraz City in 1388.

Shiraz University of Medical Sciences1 site in 1 country130 target enrollmentOctober 2009

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Hemodialysis Patients
Sponsor
Shiraz University of Medical Sciences
Enrollment
130
Locations
1
Primary Endpoint
vaccine effectiveness
Status
Completed
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2009
End Date
February 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

vaccine effectiveness

Time Frame: 3 months

serum antibody response measured by ELIZA method time frame:1 and 3 months after vaccination

Study Sites (1)

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