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The Immunogenicity of Intradermal Influenza Vaccination in Hemodialysis Patients

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ClinicalTrials.gov Identifier: NCT01273974
Recruitment Status : Completed
First Posted : January 11, 2011
Last Update Posted : January 11, 2011
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Hemodialysis Patients Biological: intradermal influenza vaccine Biological: intramuscular influenza vaccine Phase 2 Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : October 2009
Primary Completion Date : November 2009
Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Flu Flu Shot
U.S. FDA Resources

Arm Intervention/treatment
Experimental: intradermal influenza vaccine Biological: intradermal influenza vaccine
0.25ml ,intradermal
Active Comparator: intramuscular influenza vaccine Biological: intramuscular influenza vaccine
0.5ml,intramuscular



Primary Outcome Measures :
  1. vaccine effectiveness [ Time Frame: 3 months ]
    serum antibody response measured by ELIZA method time frame:1 and 3 months after vaccination



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
ClinicalTrials.gov Identifier: NCT01273974     History of Changes
Other Study ID Numbers: 89-5905
First Posted: January 11, 2011    Key Record Dates
Last Update Posted: January 11, 2011
Last Verified: August 2010

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

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs