Anna R Giuliano1, Elmar A Joura2, Suzanne M Garland3, Warner K Huh4, Ole-Erik Iversen5, Susanne K Kjaer6, Alex Ferenczy7, Robert J Kurman8, Brigitte M Ronnett9, Mark H Stoler10, Oliver M Bautista11, Erin Moeller12, Michael Ritter13, Christine Shields14, Alain Luxembourg15. 1. Center for Infection Research in Cancer, Moffitt Cancer Center, Tampa, FL, United States. Electronic address: anna.giuliano@moffitt.org. 2. Department of Obstetrics and Gynecology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria. Electronic address: elmar.joura@meduniwien.ac.at. 3. Department of Obstetrics and Gynaecology, The University of Melbourne, Victoria, Australia; Centre for Women's Infectious Diseases Research, The Royal Women's Hospital, Parkville, Victoria, Australia; Infection and Immunity, Murdoch Children's Research Institute, Victoria, Australia. Electronic address: suzanneg@unimelb.edu.au. 4. Division of Gynecologic Oncology, University of Alabama at Birmingham, Birmingham, AL, United States. Electronic address: whuh@uabmc.edu. 5. Department of Gynecology and Obstetrics, Haukeland University Hospital, Bergen, Norway; Department of Clinical Science, University of Bergen, Bergen, Norway. Electronic address: ole-erik.iversen@uib.no. 6. Unit of Virus, Lifestyle and Genes, Danish Cancer Society, Copenhagen, Denmark; Department of Gynecology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark. Electronic address: susanne@cancer.dk. 7. Department of Pathology, McGill University Health Center and Jewish General Hospital, Montreal, QC, Canada. Electronic address: alex.ferenczy@mcgill.ca. 8. Department of Pathology, The Johns Hopkins University School of Medicine, Baltimore, MD, United States; Department of Gynecology and Obstetrics, The Johns Hopkins University School of Medicine, Baltimore, MD, United States. Electronic address: rkurman@jhmi.edu. 9. Department of Pathology, The Johns Hopkins University School of Medicine, Baltimore, MD, United States; Department of Gynecology and Obstetrics, The Johns Hopkins University School of Medicine, Baltimore, MD, United States. Electronic address: bronnett@jhmi.edu. 10. Department of Pathology, University of Virginia Health System, Charlottesville, VA, United States. Electronic address: mhs2e@virginia.edu. 11. Merck & Co., Inc., Kenilworth, NJ, United States. Electronic address: oliver_bautista@merck.com. 12. Merck & Co., Inc., Kenilworth, NJ, United States. Electronic address: erin_moeller@merck.com. 13. Merck & Co., Inc., Kenilworth, NJ, United States. Electronic address: michael_ritter@merck.com. 14. Merck & Co., Inc., Kenilworth, NJ, United States. Electronic address: christine_shields@merck.com. 15. Merck & Co., Inc., Kenilworth, NJ, United States. Electronic address: alain_luxembourg@merck.com.
Abstract
OBJECTIVE: Nine-valent human papillomavirus (9vHPV) vaccine efficacy against disease and cervical surgeries related to all nine vaccine components was assessed compared with a historic placebo population. This was not assessed in the 9vHPV vaccine efficacy trial since the trial was quadrivalent HPV (qHPV) vaccine-controlled, efficacy was measured for the five HPV types covered only by 9vHPV vaccine (HPV31/33/45/52/58), but not the four types covered by both vaccines (HPV6/11/16/18). METHODS: Three international, randomized, double-blind studies were conducted using the same methodology. In the 9vHPV vaccine study (NCT00543543), 7106 and 7109 women received9vHPV or qHPV vaccine, respectively. In the historic qHPV vaccine studies (FUTURE I [NCT00092521] and II [NCT00092534]), 8810 and 8812 women receivedqHPV vaccine or placebo, respectively, based on the same eligibility criteria. Cervical cytological testing was performed regularly. Biopsy or definitive therapy specimens were assessed for HPV DNA. RESULTS: Among women negative for 14 HPV types prior to vaccination, incidence of high-grade cervical disease (9vHPV, n = 2 cases; placebo, n = 141 cases) and cervical surgery (9vHPV, n = 3 cases; placebo, n = 170 cases) related to the nine HPV types was reduced by 98.2% (95% confidence interval [CI], 93.6-99.7) and 97.8% (95% CI, 93.4-99.4), respectively. The 9vHPV vaccine did not prevent disease related to vaccine HPV types detected at baseline, but significantly reduced cervical, vulvar, and vaginal diseases related to other vaccine HPV types. CONCLUSIONS: Effective implementation of the 9vHPV vaccine may substantially reduce the burden of HPV-related diseases and related medical procedures. TRIAL REGISTRATIONS: clinicaltrials.gov: NCT00543543, NCT00092521, NCT00092534.
RCT Entities:
OBJECTIVE: Nine-valent human papillomavirus (9vHPV) vaccine efficacy against disease and cervical surgeries related to all nine vaccine components was assessed compared with a historic placebo population. This was not assessed in the 9vHPV vaccine efficacy trial since the trial was quadrivalent HPV (qHPV) vaccine-controlled, efficacy was measured for the five HPV types covered only by 9vHPV vaccine (HPV31/33/45/52/58), but not the four types covered by both vaccines (HPV6/11/16/18). METHODS: Three international, randomized, double-blind studies were conducted using the same methodology. In the 9vHPV vaccine study (NCT00543543), 7106 and 7109 women received 9vHPV or qHPV vaccine, respectively. In the historic qHPV vaccine studies (FUTURE I [NCT00092521] and II [NCT00092534]), 8810 and 8812 women received qHPV vaccine or placebo, respectively, based on the same eligibility criteria. Cervical cytological testing was performed regularly. Biopsy or definitive therapy specimens were assessed for HPV DNA. RESULTS: Among women negative for 14 HPV types prior to vaccination, incidence of high-grade cervical disease (9vHPV, n = 2 cases; placebo, n = 141 cases) and cervical surgery (9vHPV, n = 3 cases; placebo, n = 170 cases) related to the nine HPV types was reduced by 98.2% (95% confidence interval [CI], 93.6-99.7) and 97.8% (95% CI, 93.4-99.4), respectively. The 9vHPV vaccine did not prevent disease related to vaccine HPV types detected at baseline, but significantly reduced cervical, vulvar, and vaginal diseases related to other vaccine HPV types. CONCLUSIONS: Effective implementation of the 9vHPV vaccine may substantially reduce the burden of HPV-related diseases and related medical procedures. TRIAL REGISTRATIONS: clinicaltrials.gov: NCT00543543, NCT00092521, NCT00092534.
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