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Vaccine Prevents HPV Infection and Early Cervical Lesions

Vaccine recipients were significantly less likely than controls to develop HPV infections in this randomized trial.

Persistent infection with oncogenic strains of human papilloma virus (HPV), especially two prevalent high-risk types (HPV-16 and HPV-18), causes a large proportion of cervical malignancies. With funding and coordination from the vaccine manufacturer, researchers in North America and Brazil assessed the efficacy of a bivalent HPV-16/18 vaccine against new and persistent HPV infection, abnormal cytology, and cervical intraepithelial neoplasia (CIN).

Researchers randomized 1113 women (age range, 15-25) who had no histories of HPV infection or abnormal cervical cytology to receive three doses of HPV vaccine or placebo during a 6-month period. The women were followed for evidence of HPV infection and cervical lesions with periodic Pap smears and self-collected cervicovaginal swabs for as long as 27 months.

Among women who completed the protocol, vaccine recipients were significantly less likely than placebo recipients to develop incident HPV infection (0.6% vs. 6.5%), persistent infection (0% vs. 2%), or abnormal cervical cytology (0.4% vs. 4.9%). Six patients in the placebo group and one in the vaccine group developed CIN -- too few to show a significant difference. No serious vaccine-related adverse events occurred. All women who completed the protocol developed antibodies against HPV-16 and HPV-18; average antibody titers were much higher than those that occur during natural infection.

Comment: The HPV vaccine is likely to become the first licensed vaccine to prevent this common sexually transmitted disease. Larger, longer trials are needed to demonstrate that it can prevent cervical cancer. If successful, this vaccine could reduce cervical cancer morbidity and mortality greatly, particularly in the developing world, where routine screening often is unavailable, and where mortality rates from cervical cancer still are very high.

— Bruce Soloway, MD

Published in Journal Watch General Medicine December 7, 2004

Citation(s):

Harper DM 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 Nov 13; 364:1757-65.

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