Vaccine Against HPV-16 and, Possibly, Cervical Cancer

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Summary and Comment

Vaccine Against HPV-16 and, Possibly, Cervical Cancer

A vaccine against human papillomavirus type 16 protected young women from persistent infection with this cervical cancer-related virus.

Cervical cancer is the second-ranking cause of cancer deaths in women worldwide. Almost all cases of cervical cancer are associated with human papillomavirus (HPV) infection, particularly HPV-16, which is present in nearly 50% of cases.

In an industry-funded study, a U.S. multicenter team randomized 2392 young women to receive 3 doses of an intramuscular vaccine that contained HPV-16 virus-like particles (not live virus) or placebo. Sixty-four percent of the women did not have evidence of HPV-16 infection at study entry: After a median follow-up of 17.4 months, significantly more cases of persistent HPV-16 infection were found in the placebo group than in the vaccine group (3.8 cases/100 woman-years vs. 0 cases). All 9 cases of HPV-16-related cervical intraepithelial neoplasia occurred in the placebo group. Among women who were infected with HPV-16 at study entry, rates of persistent HPV-16 infection were 6.3 and 0.6 cases/100 woman-years in the placebo and vaccine groups, respectively. No serious vaccine-related adverse events were reported, and symptoms that might have indicated adverse reactions were no more common in the vaccine group than in the placebo group.

Comment: The results of this large, well-designed study provide convincing evidence that this new vaccine can protect nearly perfectly against persistent HPV-16 infection and the preneoplastic conditions caused by such infection. This vaccine, or better yet, one that would protect against additional cancer-associated HPVs, might prove to be the most important intervention yet against cervical cancer.

— Anthony L. Komaroff, MD

Published in Journal Watch General Medicine December 3, 2002