The Immunogenicity of Intradermal Influenza Vaccination in Hemodialysis Patients

This study has been completed.
Sponsor:
Information provided by:
Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01273974
First received: January 10, 2011
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Hemodialysis Patients
Biological: intradermal influenza vaccine
Biological: intramuscular influenza vaccine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Comparison of Serum Antibody Response to Standard Intramuscular and Half Dose Intradermal Influenza Vaccine in Hemodialysis Patients in Shiraz City in 1388.

Resource links provided by NLM:


Further study details as provided by Shiraz University of Medical Sciences:

Primary Outcome Measures:
  • vaccine effectiveness [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    serum antibody response measured by ELIZA method time frame:1 and 3 months after vaccination


Enrollment: 130
Study Start Date: October 2009
Study Completion Date: February 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: intradermal influenza vaccine Biological: intradermal influenza vaccine
0.25ml ,intradermal
Active Comparator: intramuscular influenza vaccine Biological: intramuscular influenza vaccine
0.5ml,intramuscular

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01273974

Locations
Iran, Islamic Republic of
Shiraz University Of Medical Science
Shiraz, Iran, Islamic Republic of
Sponsors and Collaborators
Shiraz University of Medical Sciences
Investigators
Principal Investigator: Mohammad mahdi Sagheb Shiraz University Of Medical Science
Principal Investigator: Samira Saeian Shiraz University Of Medical Science
Principal Investigator: Jamshid Roozbeh Shiraz University Of Medical Science
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01273974     History of Changes
Other Study ID Numbers: 89-5905
Study First Received: January 10, 2011
Last Updated: January 10, 2011
Health Authority: Iran: Ministry of Health

Keywords provided by Shiraz University of Medical Sciences:
intradermal influenza vaccine
hemodialysis patients

ClinicalTrials.gov processed this record on September 30, 2014