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Therapeutic HPV Vaccination for Preventing Progression of Vulvar Intraepithelial Neoplasia

Clinical responses were achieved in women with grade 3 VIN who were vaccinated against HPV-16 viral oncoproteins.

Human papillomavirus (HPV)-associated grade 3 vulvar intraepithelial neoplasia (VIN) often progresses to carcinoma. HPV-16 is the most common cause of VIN. In a phase II trial, investigators tested a vaccine against HPV-16 viral oncoproteins E6 and E7 in 22 women with HPV-16 grade 3 VIN (20 of whom received 3 or 4 doses).

All patients reported local reactions, and most reported fever (especially after the second dose); no adverse events exceeded grade 2. After 3 months of follow-up, 11 women reported symptomatic improvements, 5 achieved complete clinical and biopsy-documented responses (4 of which included loss of HPV-16), and 7 experienced partial responses. At 12 months, 9 women achieved complete responses and 6 had partial responses. Women with complete responses had smaller lesions at study entry than did those with partial or no responses. Vaccination was associated with HPV-specific CD4⁺ and CD8⁺ T cell responses; the magnitude of these cellular responses was higher among women who responded clinically than among those who did not.

Comment: Although the currently available quadrivalent and bivalent HPV vaccines are effective for preventing vaccine-specific HPV acquisition, they do not prevent progression of HPV-associated oncogenesis among women who are already infected. The present results suggest that stimulating HPV-specific cellular immune responses against viral oncogenes can lead to improvement or clearing of VIN in a manner consistent with the action of imiquimod (Aldara), a topical immunomodulatory agent (JW Womens Health Apr 3 2008). Further study of this vaccine should be aimed at extending its efficacy to other HPV types while also modifying the preparation to minimize local and systemic reactions. Overall, immunotherapeutic approaches to preneoplastic or early neoplastic lesions are promising and might also work against other virally mediated cancers.

— Anna Wald, MD, MPH

Published in Journal Watch Women's Health November 4, 2009

Citation(s):

Kenter GG et al. Vaccination against HPV-16 oncoproteins for vulvar intraepithelial neoplasia. N Engl J Med 2009 Nov 5; 361:1838.

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Finn OJ and Edwards RP. Human papillomavavirus vaccine for cancer prevention. N Engl J Med 2009 Nov 5; 361:1899.

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