HPV VLP as adjunct therapy for genital warts
A phase 1b, multicentre study of CICRVax6 HPV6L1 VLPs as therapy for genital warts
Centre for Immunology and Cancer Research, University of Queensland
480 participants
Nov 1, 2005
Interventional
Conditions
Summary
Anticipated trial start date: February 2006 (Brisbane), November 2005 (Wenzhou China) Target sample size: 240 (120 male, 120 female) at each site
Eligibility
Inclusion Criteria1
- 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.
Exclusion Criteria1
- Patients have hypersensitivity to any component of the vaccine or patients currently taking systemic immunosuppressive or immunodulative medication, or topical imiquimod as wart therapy.
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Interventions
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.
Locations(1)
View Full Details on ANZCTR
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ACTRN12605000674639