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Women already infected with human papilloma virus (HPV) don't benefit from vaccination with the bivalent HPV-16/18 L1 virus-like particle vaccine. In a phase III trial, more than 2000 women with confirmed HPV DNA in cervical specimens, aged 18-25 years, were randomised to receive three doses of the vaccine or a control vaccine for hepatitis A.
Vaccination with HPV-16/18 vaccine didn't improve clearance of type 16 or type 18 HPV at six or 12 months of follow-up. At six months, women randomised to the intervention had an HPV-16/18 virus clearance rate of 33.4% (82/248), compared with 31.6% (95/298) in the control group, giving a vaccine efficacy for viral clearance of 2.5% (95% CI −9.8% to 13.5%). Corresponding rates at 12 months were 48.8% (86/177) and 49.8% (110/220), and vaccine efficacy for viral clearance was −2.0% (−24.3% to 16.3%).
A linked editorial (p 805) says these results are consistent with those of a recent trial of the quadrivalent HPV-6/11/16/18 vaccine, which didn't slow down progression to cervical intraepithelial neoplasia in women infected with HPV at baseline. These new results confirm that neither vaccine works therapeutically. Policies should still aim to vaccinate girls before they first have sex. The cost effectiveness of vaccinating older women should be assessed in the future.