BMJ  2005;330 (5 February), doi:10.1136/bmj.330.7486.0-g

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POEM^*

Vaccine is effective against HPV

Question Is a vaccine effective against human papillomavirus (HPV) strains associated with cervical cancer?

Synopsis This team of researchers randomly assigned healthy women aged 15 to 25 with no more than six sexual partners and no history of condyloma or cervical cancer to receive a bivalent vaccine active against HPV serotypes 16 and 18 or placebo. They administered the vaccine or placebo at 0, 1, and 6 months and evaluated the patients after 27 months for HPV infection or cytological abnormalities. With an intention to treat approach to these outcomes, the vaccine was 95% effective against persistent HPV infection and 93% effective against cytological abnormalities associated with HPV. In the intention to treat analysis, the absolute reduction was 6.4% for new HPV infections (number needed to treat (NNT) = 16) and 3.5% for persistent infections (NNT = 29). Other than symptoms at the site of injection, there were no differences in side effects between the active and placebo vaccines.

Bottom line A bivalent vaccine against human papillomavirus types 16 and 18 is well tolerated and effective in reducing HPV infection and cytological abnormalities associated with HPV. What we need now is a larger, longer termed, adequately powered study to look at the effect of this vaccine on the development of cervical cancer.

Level of evidence 1b (see www.infopoems.com/levels.html). Individual randomised controlled trials (with narrow confidence interval).

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Harper DM, Franco EL, Wheeler C, et al. Efficacy of a bivalent L1 virus-like particle vaccine in prevention of infection with human papillomavirus types 16 and 18 in young women: a randomised controlled trial. Lancet 2004;364: 1757-65[CrossRef][Web of Science][Medline].

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^* Patient-Oriented Evidence that Matters. See editorial ( BMJ 2002;325: 983[Free Full Text])

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