CompletedPhase 4ACTRN12608000440325

The response of vasculitis patients to influenza vaccination compared to healthy individuals

The immunological response of patients with anti-neutrophil cytoplasmic antibody (ANCA) vasculitis to the influenza vaccine compared to healthy individuals.


Sponsor

Royal Adelaide Hospital

Enrollment

100 participants

Start Date

Apr 1, 2007

Study Type

Interventional

Conditions

Summary

Patients with ANCA (Anti-neutrophil cytoplasmic antibodies) vasculitis and healthy individuals were recruited to assess their response to influenza vaccination. It was anticipated that the the response to the vaccine by the patients would be less than the healthy control group, but still sufficient to provide protection against the influenza virus. The response of healthy individuals and those with ANCA vasculitis will be compared. Patients with ANCA vasculitis were monitored throughout the study to determine whether the influenza vaccination caused any change in their disease activity.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria2

  • Patients: Have biopsy-proven ANCA (Anti-neutrophil cytoplasmic antibodies) vasculitis and are currently in remission.
  • Healthy controls: Fit and well with no significant infection in the past month.

Exclusion Criteria2

  • Patients: Received an organ transplant, have end-stage renal failure, have a contraindication to receiving the influenza vaccine including egg allergy, pregnant
  • Controls: Diabetes, receiving any oral immunosuppressant therapy, Pregnancy, any significant end-organ disease.

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Interventions

Administration of inactivated trivalent influenza vaccine (CSL brand Fluvax). 1.Dosage used 0.5mL 2.Administered as deep subcutaneous injection in deltoid region 3.Single administration of injecti

Administration of inactivated trivalent influenza vaccine (CSL brand Fluvax). 1.Dosage used 0.5mL 2.Administered as deep subcutaneous injection in deltoid region 3.Single administration of injection only to all participants. 4.Overall intervention period 1 month, single dose only though given on Day 0 and all subjects followed until day 28.


Locations(1)

Australia

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ACTRN12608000440325