None listed
Conditions
Brief 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.
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 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.
Sponsors
Royal Adelaide Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 criteria
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.
Outcome results
None listed