The Immunogenicity of Intradermal Influenza Vaccination in Hemodialysis Patients

Shiraz University of Medical Sciences

Status and phase: Completed; Phase 3; Phase 2

Conditions: Hemodialysis Patients

Treatments: Biological: intramuscular influenza vaccine; Biological: intradermal influenza vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT01273974

89-5905

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

intradermal influenza vaccine

Experimental group

Treatment:

Biological: intradermal influenza vaccine

intramuscular influenza vaccine

Active Comparator group

Treatment:

Biological: intramuscular influenza vaccine