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| | | ![]() Quadrivalent HPV Vaccination Reduces Cervical Procedures, Abnormal Pap Tests: Presented at IPV By Bruce Sylvester MALMÖ, Sweden -- May 12, 2009 -- Within 4 years of administration, quadrivalent human papillomavirus (HPV) vaccination of HPV-naïve women reduces cervical procedures and abnormal Pap tests, researchers stated here on May 10 at the 25th International Papillomavirus Conference (IPV). "Administration of the quadrivalent vaccine significantly reduced the incidence of abnormal Pap tests and cervical procedures within only 3.5 years, irrespective of the HPV type involved," said presenter and investigator Jorma Paavonen, MD, University of Helsinki, Helsinki, Finland. "Our results provide strong evidence that the ongoing HPV vaccination programs in adolescent girls and young women will result within a few years in a notable reduction in cervical cytological abnormalities, and in diagnostic and therapeutic procedures related to precursor lesions," he added. The investigators analysed end-of-study data from 2 pivotal phase 3 trials of the quadrivalent vaccine. There were 17,622 women enrolled in these randomised, placebo-controlled, efficacy trials. Participants received vaccine or placebo on day 1, month 2, and month 6. All subjects underwent cervicovaginal sampling at day 1. Pap testing took place at day 1 and every 6 to 12 months thereafter. Referrals for colposcopy referral were Pap algorithm/HPV test-based. Therapeutic referrals were made using accepted standards of care. The investigators conducted the data analyses without regard of causal HPV type; they were conducted for subjects who, at day 1, had a negative Pap test and were negative to 14 common HPV types. The investigators used these parameters in order to approximate a primary target population for HPV vaccination, sexually naïve girls, and women shortly postsexual debut and/or with few lifetime sex partners. After an average follow-up of 3.6 years post day 1, the investigators reported finding significant reductions among these HPV-naïve women (vaccinated subjects = 4,616; placebo subjects = 4,679) in Pap tests, colposcopy, cervical biopsy, and definitive therapy. "Administration of quadrivalent HPV vaccination to HPV-naïve women reduced the incidence of cervical procedures and abnormal Pap tests within 4 years, irrespective of the HPV type involved," the authors concluded. Funding for this study was supported by Merck.
[Presentation title: Impact of HPV6/11/16/18 Vaccine on Abnormal Pap Tests and Procedures. Abstract O-01.08]
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