EUCTR2008‐008251‐42‐NL.

Trial name or title	Clinical and immunological effects of imiquimod and HPV‐vaccination compared to imiquimod alone in women with uVIN ‐ effects of HPV‐vaccination and imiquimod in VIN patients
Methods	Double‐blind, parallel‐arm, placebo‐controlled RCT
Participants	Inclusion criteria: Histological proven usual type VIN, without invasion Previous treatment with imiquimod for 12 to 16 weeks with a partial response to imiquimod treatment defined as a reduction in lesion size of 26% to 99% The patient is willing to use a medically acceptable method of contraception throughout the study Age 18 and above Exclusion criteria: (Micro‐)invasive carcinoma Pregnancy and/or breastfeeding Past history of vulval cancer Differentiated (non HPV‐related) VIN Other treatment of VIN or anogenital warts within 1 month of start of trial Hypersensitivity to any components of the vaccine or cream formulation History of psoriasis or other inflammatory dermatosis of the vulva Immunodeficiency (e.g. HIV, systemic corticosteroid use) Insufficient understanding of the Dutch language Partial responders who are disease‐free at study entry due to other treatment of VIN
Interventions	Arm 1: HPV vaccination (Gardasil®) followed by topical applications of imiquimod (5% cream) Arm 2: placebo vaccination (saline) followed by topical applications of imiquimod (5% cream)
Outcomes	Clinical efficacy (measured by reduction in lesion size, histological regression to normal tissue and relief of symptoms); systemic and local immunological response (immune cell counts, cytokine production, HPV‐specific antibody titers); HPV DNA presence (0 and 36 weeks); QoL at baseline and 36 weeks
Starting date	2009
Contact information	M.I.E.van_Poelgeest@lumc.nl
Notes	This trial has been completed. Results are awaited.