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Quadrivalent HPV Vaccine Shows Long-Term Efficacy Against HPV 16: Presented at IPV By Bruce Sylvester MALMÖ, Sweden -- May 12, 2009 -- Women who were uninfected with human papillomavirus (HPV) type 16 at the time of administration of the quadrivalent HPV vaccine have remained infection-free for an average of 8.5 years, researchers reported here on May 10 at the 25th International Papillomavirus Conference (IPV). "This quadrivalent vaccination provides strong and sustained protection against HPV 16, which gives us hope for the ongoing long-term efficacy of this vaccination against this cancer-causing HPV type," said presenter and lead investigator Ali Rowhani-Rahbar, MD, HPV Research Group, University of Washington School of Public Health, Seattle, Washington. The investigators noted that HPV types 16 and 18 are responsible for approximately 70% of cervical cancer cases. And, to date, there had been no data available on efficacy of any HPV vaccine beyond 5.5 years of follow-up. Between March 2006 and May 2008, investigators enrolled 290 patients who had participated in a previous Seattle-based randomised, placebo-controlled, phase 2b trial of the vaccine (November 1998-January 2004). Eligible subjects in the follow-up trial had not been infected with HPV 16 either at the start of the initial trial or through month 7 of that trial (1 month after completion the 3 dose series of vaccinations). Following the initial study, all placebo subjects were offered the quadrivalent vaccination; only those who had refused and who consented to be in the follow-up were enrolled in the second study. Dr. Rowhani-Rahbar reported that no one in the vaccinated group developed HPV 16 infection (vaccine efficacy = 100%; 95% confidence interval [CI], 25%-100%) or HPV-16-associated cervical lesions (cervical intraepithelial neoplasia [CIN]; vaccine efficacy = 100%; 95% CI, <0%-100%) during the follow-up period. Among the placebo-treated patients, 6 women developed HPV-16 infection and 3 women developed HPV-16-associated CIN during the follow-up period. During the combined periods of both trials, 1 vaccinated woman developed HPV-16 infection and no woman developed HPV-16-associated CIN; 21 placebo-treated women developed HPV-16 infection (vaccine efficacy = 96%; 95% CI, 73%-100%), and 8 women developed HPV-16-associated CIN (vaccine efficacy = 100%; 95% CI, 47%-100%). Dr. Rowhani-Rahbar noted that the wide confidence intervals were the result of many subjects having left the Seattle area by the time of the follow-up study, or for other reasons (change of address, marriage, etc) having been unable/unwilling to participate. "Long-lasting, high-level efficacy against HPV 16 may translate into prevention of a substantial number of cervical cancer cases in the United States and worldwide. Large, population-based, long-term follow-up studies of the quadrivalent vaccine are ongoing," he concluded. Funding for this study was provided by Merck & Co., Inc. [Presentation title: Long-Term Efficacy of a Prophylactic Human Papillomavirus Type 16 Vaccine: Oral Presentation 0-01.03] E-mail this page to a friend or colleague! To print, use this version