The Immunogenicity of Intradermal Influenza Vaccination in Hemodialysis Patients

Hemodialysis Patients Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01273974
• Other study ID #: 89-5905
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 10, 2011
• Last updated: January 10, 2011
• Start date: October 2009
• Est. completion date: February 2010

Study information

• Verified date: August 2010
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: February 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hemodialysis Patients

Intervention

Biological:
• intradermal influenza vaccine
0.25ml ,intradermal
• intramuscular influenza vaccine
0.5ml,intramuscular

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shiraz University Of Medical Science	Shiraz

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vaccine effectiveness	serum antibody response measured by ELIZA method time frame:1 and 3 months after vaccination	3 months	Yes

External Links

•   Link