HIPvac: a trial of vaccination and topical treatment in patients with anogenital warts

Phase 1

• Conditions: Anogenital warts; MedDRA version: 20.1 Level: PT Classification code 10059313 Term: Anogenital warts System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: LLT Classification code 10018182 Term: Genital warts System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2013-002951-14-GB
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-01-17
• Study Start: 2019-01-14
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 503

Inclusion Criteria

Males and females
• First episode or repeat episode of anogenital warts diagnosed clinically
• External anogenital warts considered, in the opinion of the investigator, to be suitable for selfadministered
topical
wart treatment (patients with concurrent internal anogenital warts are still eligible to participate).
• Able to provide informed consent to participate in the trial.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1000
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Previous wart treatment in the last 3 months
• Previous quadrivalent HPV vaccine (previous bivalent HPV vaccine is not an exclusion criterion).
• Previous intolerance to either of the topical treatments, vaccines or their constituents
• Known HIVpositivity
(HIV testing is not required for the trial).
• Pregnancy or lactation (current, or planned in the next 6 months)
• Women of child bearing potential not willing to use effective contraception for the duration and 30 days post
completion of trial treatment: see above
• Unable or unwilling to complete followup
procedures
• Lesion area greater than 4 cm2, requiring treatment under direct supervision of medical staff (in accordance with
podophyllotoxin cream Summary of Product Characteristics).
• Patients who have had topical steroids applied to the target area, or systemic steroids or other immunosuppressive
agents, within 1 month prior to randomisation
• Patients enrolled in any other trial of an Investigational Medicinal Product, without the permission of the Chief
Investigator.
• Any clinical condition which the

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified