HPV VLP as adjunct therapy for genital warts

A phase 1b, multicentre study of CICRVax6 HPV6L1 VLPs as therapy for genital warts

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000674639

Enrollment

480

Registered

2005-10-21

Start date

2005-11-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Anticipated trial start date: February 2006 (Brisbane), November 2005 (Wenzhou China) Target sample size: 240 (120 male, 120 female) at each site

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

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.

Outcome results