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Trial registered on ANZCTR


Registration number
ACTRN12608000440325
Ethics application status
Approved
Date submitted
29/07/2008
Date registered
3/09/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The response of vasculitis patients to influenza vaccination compared to healthy individuals
Scientific title
The immunological response of patients with anti-neutrophil cytoplasmic antibody (ANCA) vasculitis to the influenza vaccine compared to healthy individuals.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis 3464 0
Condition category
Condition code
Inflammatory and Immune System 3626 3626 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 3194 0
Treatment: Drugs
Comparator / control treatment
No treatment
Those individuals in the control arm did not receive an injection (ie no placebo) on Day 0 and as such the trial was not blinded. They literally received no treatment. The control individuals who did not receive the vaccine on Day 0 were offerred to receive the vaccine on Day 28 if they wished.
Control group
Active

Outcomes
Primary outcome [1] 4520 0
Primary outcome: Immunological response to the influenza vaccine measured by haemagglutination-inhibition assays (HAI)
Timepoint [1] 4520 0
Day 0, Day 7 and Day 28
Secondary outcome [1] 7649 0
Anti-neutrophil cytoplasmic antibody titres measured by ELISA (Enzyme-Linked Immunosorbent Assay)
Timepoint [1] 7649 0
Day 0, Day 7 and Day 28
Secondary outcome [2] 7650 0
BVAS (Birmingham vasculitis activity score) clinically assessed. BVAS was assessed by a telephone conversation with the patient and asking specific questions as part of a set questionnaire.
Timepoint [2] 7650 0
Day 0, Day 7 and Day 28
Secondary outcome [3] 7651 0
Measurement of biochemical markers including creatinine, c-reactive protein (CRP) and albumin. These markers were measured by a diagnostic laboratory. Creatinine was measured by a kinetic colour test using the Jaffe method to quantitatively determine the creatinine concentration in an individual's serum. An immuno-turbidimetric test was used for the quantitative determination of C-reactive protein (CRP) in human serum. Albumin was measured by dye binding and read by a diagnostic analyser.
Timepoint [3] 7651 0
Day 0, Day 7 and Day 28
Secondary outcome [4] 7652 0
Autoantibody production by the healthy control group in response to the vaccination including rheumatoid factor, double-stranded DNA (Deoxyribonucleic acid), anti-cyclic citrullinated peptide, total IgG (immune globulin G) and total IgM (immune globulin M). Levels of anti-myeloperoxidase and anti-proteinase 3 as the ANCA (anti-neutrophil cytoplasmic antibodies) were also measured. Levels of anti-myeloperoxidase, anti-proteinase and anti-cyclic citrullinated peptide were all measured using commercial ELISA (Enzyme-Linked Immunosorbent Assay) kits in duplicate. Total IgG and IgM and rheumatoid factor were measured by nephelometry in a diagnostic laboratory. Double-stranded DNA (Deoxyribonucleic acid), was measured by radioimmunoassay also by a diagnostic laboratory.
Timepoint [4] 7652 0
Day 0, Day 7 and Day 28

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table from a statistics book
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1119 0
5000

Funding & Sponsors
Funding source category [1] 3656 0
Hospital
Name [1] 3656 0
Dr Chen Au Peh
Address [1] 3656 0
Renal Unit. Royal Adelaide Hospital. North Terrace. Adelaide. South Australia. 5000
Country [1] 3656 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
Renal Unit. Royal Adelaide Hospital. North Terrace. Adelaide. South Australia. 5000
Country
Australia
Secondary sponsor category [1] 3283 0
None
Name [1] 3283 0
Address [1] 3283 0
Country [1] 3283 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5709 0
Royal Adelaide Hospital ethics Committee
Ethics committee address [1] 5709 0
Royal Adelaide Hospital. North Terrace. Adelaide. South Australia. 5000
Ethics committee country [1] 5709 0
Australia
Date submitted for ethics approval [1] 5709 0
Approval date [1] 5709 0
01/03/2007
Ethics approval number [1] 5709 0
070306

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28784 0
Address 28784 0
Country 28784 0
Phone 28784 0
Fax 28784 0
Email 28784 0
Contact person for public queries
Name 11941 0
Dr Lisa Jeffs
Address 11941 0
Renal Unit. Royal Adelaide Hospital. North Terrace. Adelaide. South Australia. 5000
Country 11941 0
Australia
Phone 11941 0
61 8 8222 4990
Fax 11941 0
Email 11941 0
lisa.jeffs@student.adelaide.edu.au
Contact person for scientific queries
Name 2869 0
Dr Lisa Jeffs
Address 2869 0
Renal Unit. Royal Adelaide Hospital. North Terrace. Adelaide. South Australia. 5000
Country 2869 0
Australia
Phone 2869 0
61 8 8222 4990
Fax 2869 0
Email 2869 0
lisa.jeffs@student.adelaide.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary