ACTRN12607000016437Not yet recruitingPhase 1
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.
Centre for Immunology and Cancer Research, University of Queensland0 sites36 target enrollmentStarted: January 9, 2007Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 36
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 1 Years to 50 Years (—)
- Sex
- All
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.
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.
Investigators
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