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Home Other HPV Cancers Other HPV Cancers Promising Early Results with Vulvar Vaccine Research

Promising Early Results with Vulvar Vaccine Research

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In a small clinical trial an experimental vaccine was highly effective in both stimulating an immune response to HPV-16 and reducing or eliminating vulvar lesions.

Vulvar cell changes, know as vulvar intraepithelial neoplasia or VIN, are lesions that most often develop in the presence of high-risk HPV, usually HPV-16. VIN is seldom dangerous (rarely progressing to cancer), but recurs frequently and usually requires frequent follow-up exams and more than one round of therapy.

While lower-grade lesions are often managed with a “watch and wait” approach, more significant disease usually requires treatment options similar to those used for cervical precancers: surgery (scalpel excision), cryotherapy (freezing the affected tissue with liquid nitrogen), or removal with laser. An HPV vaccine being developed in the Netherlands may eventually offer another treatment option, one that’s noninvasive.

Researchers gave the vaccine to a small cohort of patients with high-grade VIN related to HPV-16 and followed them for 24 months. After three months, 12 of 20 subjects had either partial (n=5) or full (n=7) clearance of lesions. Four of the five with total regression of VIN also cleared HPV-16. At 12 months, 15 of 19 patients remaining in the study saw at least partial clearance of their lesions, with VIN completely regressing in nine patients.

The investigators say the vaccine likely works by stimulating the immune system, noting that a T-cell immune response specific to HPV-16 occurred in all subjects. Blood samples taken 1 to 2 years following their last vaccine showed sustained immune response in 12 of 14 subjects.

While the vaccine is promising, additional studies with much larger number of subjects are needed to fully evaluate its effectiveness in clearing HPV diseases. In addition, women with VIN disease may have recurrences 10-20 years after initial excisional treatment. We won't know whether this type of vaccine will also prevent the recurrences until it is studied for a longer interval.

G Kenter et al. Vaccination against HPV-16 Oncoproteins for Vulvar Intraepithelial Neoplasia. New England Journal of Medicine, 2009. 361(19):1838-1847.