HPV VLP as adjunct therapy for genital warts

Phase 1

• Conditions: Patients with persistent or recurrent genital warts; Renal and Urogenital -

• Registration Number: ACTRN12605000674639
• Lead Sponsor: Centre for Immunology and Cancer Research, University of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-10-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 480

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients disease free two and six months after vaccine administration/destructive therapy.[At 2 and 6 months after vaccine administration/destructive therapy]

Secondary Outcome Measures

Name	Time	Method
Immune response to vaccine [At 1 or 2 month after administration. ];Vaccine tolerability[At each dose.]