The Immunogenicity of Intradermal Influenza Vaccination in Hemodialysis Patients

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01273974

Enrollment

130

Registered

2011-01-11

Start date

2009-10-31

Completion date

2010-02-28

Last updated

2011-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis Patients

Keywords

intradermal influenza vaccine, hemodialysis patients

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.

Interventions

BIOLOGICALintradermal influenza vaccine

0.25ml ,intradermal

BIOLOGICALintramuscular influenza vaccine

0.5ml,intramuscular

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026