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The HPV Vaccine and Cervical Neoplasia: Not Just for Warts Anymore

Widespread immunization against HPV will reduce rates of both cervical cancer and genital warts.

Genital infection with human papillomavirus (HPV) is the etiologic agent for almost all cervical cancers; approximately 70% of cases involve HPV type 16 or 18. High-grade cervical lesions often begin to develop within 2 years of HPV infection. To determine whether a quadrivalent HPV vaccine (Gardasil) could prevent cervical intraepithelial neoplasia (CIN), investigators conducted a phase 3 trial in more than 10,000 women (age range, 15–26).

Participants were randomized to receive three doses of vaccine or placebo at 0, 2, and 6 months and were followed for evidence of CIN for 2.9 years after the first vaccination. Among participants without evidence of past or present HPV infection on DNA and serologic testing at baseline, the vaccine provided 98% protection against low- and high-grade CIN and adenocarcinoma in situ. However, vaccination did not appear to affect the course of disease among those who had an abnormal Papanicolaou test at study entry.

Seroconversion to all four HPV types was greater than 99% immediately after completion of the vaccination regimen and remained high for types 6, 11, and 16 at 24 months. Serologic evidence of HPV-18 immunity, nevertheless, declined to 66% at 24 months, albeit without evident loss of efficacy. Injection-site reactions, a slight increase in seasonal allergies, and neck pain were the only adverse effects that occurred more often in vaccine recipients than in controls. Pregnancies did not appear to be adversely affected by vaccination.

Comment: For dermatologists, the primary benefit of HPV vaccine is protection against genital warts; however, we must remember that HPV infections can lead to cancer. Just as vaccines for hepatitis B have reduced the rates of liver cancer, these results strongly suggest that the consequence of widespread immunization against HPV will be fewer cases of cervical cancer. Several issues about this vaccine are still unresolved — for example, the duration of protection and whether its use in males will lead to a reduction in condyloma acuminata and bowenoid papulosis.

— Craig A. Elmets, MD

Published in Journal Watch Dermatology May 9, 2007

Citation(s):

The FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med 2007 May 10; 356:1915-27.

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