Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000674639
Ethics application status
Approved
Date submitted
20/10/2005
Date registered
21/10/2005
Date last updated
21/10/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
HPV VLP as adjunct therapy for genital warts
Scientific title
A phase 1b, multicentre study of CICRVax6 HPV6L1 VLPs as therapy for genital warts
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with persistent or recurrent genital warts 822 0
Condition category
Condition code
Renal and Urogenital 886 886 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Vaccine will be given twice over one month to patients, concurrently with administration of conventional destructive therapy. Patients with genital warts will all undergo conventional destructive therapy and will additionally be randomized in block of 4 to receive either CICRVax6 (at one of three doses) or placebo twice at week 0 and week 4.
Intervention code [1] 731 0
None
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 1149 0
Percentage of patients disease free two and six months after vaccine administration/destructive therapy.
Timepoint [1] 1149 0
At 2 and 6 months after vaccine administration/destructive therapy
Secondary outcome [1] 2113 0
Immune response to vaccine
Timepoint [1] 2113 0
At 1 or 2 month after administration.
Secondary outcome [2] 2114 0
Vaccine tolerability
Timepoint [2] 2114 0
At each dose.

Eligibility
Key inclusion criteria
Patients currently have clinically diagnosed genital warts, which were initially diagnosed at least three months ago, and have persisted or recurred after at least one course of conventional destructive treatment, willing to undergo further destructive therapy.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients have hypersensitivity to any component of the vaccine or patients currently taking systemic immunosuppressive or immunodulative medication, or topical imiquimod as wart therapy.

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)
Double blinded: patients allocated sequentially to patient numbers previously randomly allocated in block of 4 to: 3 vaccine, 1 placebo
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Blocks: One allocated to placebo by random number table generated electronically
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
480
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 978 0
Charities/Societies/Foundations
Name [1] 978 0
Wellcome Trust
Country [1] 978 0
United Kingdom
Funding source category [2] 979 0
Charities/Societies/Foundations
Name [2] 979 0
Cancer Research Institute
Country [2] 979 0
United States of America
Primary sponsor type
University
Name
Centre for Immunology and Cancer Research, University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 844 0
None
Name [1] 844 0
N/A
Address [1] 844 0
Country [1] 844 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2288 0
Brisbane Princess Alexandra Hospital Ethics Committee
Ethics committee address [1] 2288 0
Ethics committee country [1] 2288 0
Australia
Date submitted for ethics approval [1] 2288 0
Approval date [1] 2288 0
Ethics approval number [1] 2288 0

Summary
Brief summary
Anticipated trial start date: February 2006 (Brisbane), November 2005 (Wenzhou China)
Target sample size: 240 (120 male, 120 female) at each site
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35919 0
Address 35919 0
Country 35919 0
Phone 35919 0
Fax 35919 0
Email 35919 0
Contact person for public queries
Name 9920 0
Dr David Jardine
Address 9920 0
Princess Alexandra Sexual Health
Princess Alexandra Hospital
Woolloongabba QLD 4102
Country 9920 0
Australia
Phone 9920 0
+61 7 32405881
Fax 9920 0
+61 7 32405540
Email 9920 0
[email protected]
Contact person for scientific queries
Name 848 0
Professor Ian Frazer
Address 848 0
Centre for Immunology and Cancer Research
4th Floor Research Extension
Princess Alexandra Hospital
Building 1
Ipswich Road
Woolloongabba QLD 4102
Country 848 0
Australia
Phone 848 0
+61 7 32405315
Fax 848 0
+61 7 32405310
Email 848 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.