Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000016437
Ethics application status
Approved
Date submitted
30/11/2006
Date registered
9/01/2007
Date last updated
9/01/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
HPV VLP as adjunct therapy for recurrent respiratory papillomatosis.
Scientific title
A phase 1b multicentre study of CICRVax6 HPV 6L1 VLPs as an immunotherapy to prevent or prolong recurrence of recurrent respiratory papillomatosis caused by infection with Human Papilloma Virus (HPV) after conventional destructive treatment.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with persistent or recurrent respiratory papillomatosis. 1517 0
Condition category
Condition code
Respiratory 1615 1615 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The investigational vaccine human papilloma virus like particles (HPV VLPs) will be administered intramuscularly into the deltoid area of the arm. Subjects are scheduled to receive three doses with approximately 4 weeks apart.

The study includes two phases: In the first open label dose escalation phase, 6 subjects will receive, sequentially, at 4 week intervals, 1mcg, 5mcg and 25mcg of the investigational vaccine, presuming for that patient that each previous dose produces no more than grade 2-local or systemic reactivity. Symptomatology will be evaluated after each injection, before a decision is made whether to give the next higher dose. Following scale will be used to grade the severity of symptoms the subject experiences following vaccination: 0- (no adverse events); 1- Mild (does not interfere with daily activities); 2- Moderate (interfere with routine activities) and 3- Severe (unable to perform routine activities).

When 6 subjects have completed the first phase dose ranging study, a single dose will be selected for the second phase of the study – this will be the largest dose that produces an acceptable safety profile in the first phase. 12 subjects will get the vaccine, or a placebo, on three occasions. A placebo is something that looks like the vaccine but is not likely to have any effect. In this phase, 12 subjects will be randomized in blocks to receive the selected dose of vaccine or placebo. Neither the subject nor the research staff will know if the subject is receiving the vaccine or the placebo throughout the duration of the study. The anticipated trial duration will be from 01/11/2006 to 30/05/2008.
Intervention code [1] 1478 0
Treatment: Drugs
Comparator / control treatment
Phase II: placebo
Control group
Placebo

Outcomes
Primary outcome [1] 2227 0
To evaluate the immune response to investigational vaccine
Timepoint [1] 2227 0
Before and after each immunization during the duration of the study
Primary outcome [2] 2228 0
To evaluate the safety and tolerability of investigational vaccine at three dose levels
Timepoint [2] 2228 0
Weekly during the duration of the study
Secondary outcome [1] 3882 0
To determine the percentage of patients disease free two and six months after the last vaccine administration at the selected highest dose adjuvant to a conventional destructive therapy.
Timepoint [1] 3882 0

Eligibility
Key inclusion criteria
Otherwise healthy patients. Recurrent respiratory papillomatosis confirmed on laryngoscopy and by biopsy, with written case notes documenting the course of disease over the last year. Disease sufficiently severe to have required at least 3 documented excisional /ablative treatments over the 12 months prior to admission to the study. Consent from the parents after discussion with the treating paediatrician, and the third party specialist paediatrician.
Minimum age
1 Years
Maximum age
50 Years
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 (or within three months prior to enrolment) taking systemic immunosuppressive or immunodulative medication 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)
Allocation is by numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation with randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Double blinded (neither patient nor clinicians know what the patient is getting at the time of delivery).
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
1/11/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1761 0
Charities/Societies/Foundations
Name [1] 1761 0
Wellcome Trust Foundation
Country [1] 1761 0
Funding source category [2] 1762 0
Government body
Name [2] 1762 0
National Health and Medical Research Council
Country [2] 1762 0
Australia
Primary sponsor type
University
Name
Centre for Immunology and Cancer Research, University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 1561 0
None
Name [1] 1561 0
Nil
Address [1] 1561 0
Country [1] 1561 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3285 0
Brisbane Princess Alexandra Hospital Human Ethics Committee
Ethics committee address [1] 3285 0
Ethics committee country [1] 3285 0
Australia
Date submitted for ethics approval [1] 3285 0
Approval date [1] 3285 0
10/07/2006
Ethics approval number [1] 3285 0
2006/054
Ethics committee name [2] 3286 0
University of Queensland Human Ethics Committee
Ethics committee address [2] 3286 0
Ethics committee country [2] 3286 0
Australia
Date submitted for ethics approval [2] 3286 0
Approval date [2] 3286 0
28/09/2006
Ethics approval number [2] 3286 0
2006000631
Ethics committee name [3] 3287 0
Wenzhou Medical College Human Ethics Committee
Ethics committee address [3] 3287 0
Ethics committee country [3] 3287 0
China
Date submitted for ethics approval [3] 3287 0
Approval date [3] 3287 0
10/01/2006
Ethics approval number [3] 3287 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27412 0
Address 27412 0
Country 27412 0
Phone 27412 0
Fax 27412 0
Email 27412 0
Contact person for public queries
Name 10667 0
Professor William Bill Coman
Address 10667 0
Department of Otolaryngology, Head and Neck Surgery
Princess Alexandra Hospital
Woolloongabba QLD 4102
Country 10667 0
Australia
Phone 10667 0
+61 7 32402431
Fax 10667 0
+61 7 32402427
Email 10667 0
[email protected]
Contact person for scientific queries
Name 1595 0
Professor Ian Frazer
Address 1595 0
Centre for Immunology and Cancer Research
4th Floor Research Extension
Building 1
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Country 1595 0
Australia
Phone 1595 0
+61 7 32405315
Fax 1595 0
+61 7 32405310
Email 1595 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.