HPV-16 vaccine may be effective for vulvar intraepithelial neoplasia

Clinical question Does immunization with HPV-16 vaccine lead to clinical improvement or regression in patients with vulvar intraepithelial neoplasia (VIN)?

Bottom line Immunization with an HPV-16 vaccine appeared to stimulate regression in an uncontrolled case series of 20 patients. (Level of evidence = 4)

Synopsis VIN is a premalignant condition that only rarely (1.5% of the time) spontaneously regresses. In this case series, 20 otherwise healthy women with grade 3 VIN who were HPV-16 serotype positive received a series of 3 or 4 immunizations with a synthetic long-chain peptide vaccine to HPV-16. The primary outcomes were clinical response (a decrease in lesion size by 50% or more) or complete response (complete regression of all lesions). Approximately half the women had multifocal disease and approximately one-third had severe disease. The women's age range was 23 to 61 years. At 12 months follow-up, 15 of 19 patients had a clinical response and nine had a complete response (one was lost to follow-up). At 24 months, nine patients still had a complete response. Three patients developed invasive carcinoma between 6 months and 3 years after their last vaccination.

Kenter GG, Welters MJ, Valentijn AR, et al. Vaccination against HPV-16 oncoproteins for vulvar intraepithelial neoplasia? N Engl J Med. 2009;361(19):1838-1847.