Pierre Van Damme1, Sven Eric Olsson2, Stanley Block3, Xavier Castellsague4, Glenda E Gray5, Teobaldo Herrera6, Li-Min Huang7, Dong Soo Kim8, Punnee Pitisuttithum9, Joshua Chen10, Susan Christiano10, Roger Maansson10, Erin Moeller10, Xiao Sun10, Scott Vuocolo10, Alain Luxembourg10. 1. Center for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium; pierre.vandamme@uantwerp.be. 2. Karolinska Institute at Danderyd Hospital, Uppsala, Sweden; 3. Kentucky Pediatric/Adult Research, Inc, Bardstown, Kentucky; 4. Institut Català d'Oncologia, IDIBELL, CIBERESP, L'Hospitalet De Llobregat, Catalonia, Spain; 5. Department of Pediatrics, University of the Witwatersrand, Johannesburg, South Africa; 6. Instituto de Investigation Nutricional, Lima, Peru; 7. Division of Infectious Diseases, Children's Hospital, National Taiwan University College of Medicine, Taipei, Taiwan; 8. Division of Infectious Disease and Immunology, Department of Pediatrics, Yonsei University College of Medicine, Severance Children's Hospital, Seoul, Korea; 9. Faculty of Tropical Medicine, Mahidol University, Nakhon Pathom, Thailand; and. 10. Merck and Company, Inc, Whitehouse Station, New Jersey.
Abstract
OBJECTIVES: Prophylactic vaccination of youngwomen aged 16 to 26 years with the 9-valent (6/11/16/18/31/33/45/52/58) human papillomavirus (HPV) virus-like particle (9vHPV) vaccine prevents infection and disease. We conducted a noninferiority immunogenicity study to bridge the findings in young women to girls and boys aged 9 to 15 years. METHODS: Subjects (N = 3066) received a 3-dose regimen of 9vHPV vaccine administered at day 1, month 2, and month 6. Anti-HPV serologic assays were performed at day 1 and month 7. Noninferiority required that the lower bound of 2-sided 95% confidence intervals of geometric mean titer ratios (boys:young women or girls:young women) be >0.67 for each HPV type. Systemic and injection-site adverse experiences (AEs) and serious AEs were monitored. RESULTS: At 4 weeks after dose 3, >99% of girls, boys, and young women seroconverted for each vaccine HPV type. Increases in geometric mean titers to HPV types 6/11/16/18/31/33/45/52/58 were elicited in all vaccine groups. Responses in girls and boys were noninferior to those of young women. Persistence of anti-HPV responses was demonstrated through 2.5 years after dose 3. Administration of the 9vHPV vaccine was generally well tolerated. A lower proportion of girls (81.9%) and boys (72.8%) than young women (85.4%) reported injection-site AEs, most of which were mild to moderate in intensity. CONCLUSIONS: These data support bridging the efficacy findings with 9vHPV vaccine in young women 16 to 26 years of age to girls and boys 9 to 15 years of age and implementing gender-neutral HPV vaccination programs in preadolescents and adolescents.
RCT Entities:
OBJECTIVES: Prophylactic vaccination of youngwomen aged 16 to 26 years with the 9-valent (6/11/16/18/31/33/45/52/58) human papillomavirus (HPV) virus-like particle (9vHPV) vaccine prevents infection and disease. We conducted a noninferiority immunogenicity study to bridge the findings in young women to girls and boys aged 9 to 15 years. METHODS: Subjects (N = 3066) received a 3-dose regimen of 9vHPV vaccine administered at day 1, month 2, and month 6. Anti-HPV serologic assays were performed at day 1 and month 7. Noninferiority required that the lower bound of 2-sided 95% confidence intervals of geometric mean titer ratios (boys:young women or girls:young women) be >0.67 for each HPV type. Systemic and injection-site adverse experiences (AEs) and serious AEs were monitored. RESULTS: At 4 weeks after dose 3, >99% of girls, boys, and young women seroconverted for each vaccine HPV type. Increases in geometric mean titers to HPV types 6/11/16/18/31/33/45/52/58 were elicited in all vaccine groups. Responses in girls and boys were noninferior to those of young women. Persistence of anti-HPV responses was demonstrated through 2.5 years after dose 3. Administration of the 9vHPV vaccine was generally well tolerated. A lower proportion of girls (81.9%) and boys (72.8%) than young women (85.4%) reported injection-site AEs, most of which were mild to moderate in intensity. CONCLUSIONS: These data support bridging the efficacy findings with 9vHPV vaccine in young women 16 to 26 years of age to girls and boys 9 to 15 years of age and implementing gender-neutral HPV vaccination programs in preadolescents and adolescents.
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Authors: Alex Vorsters; Marc Arbyn; Marc Baay; Xavier Bosch; Silvia de Sanjosé; Sharon Hanley; Emilie Karafillakis; Pier Luigi Lopalco; Kevin G Pollock; Joanne Yarwood; Pierre Van Damme Journal: Papillomavirus Res Date: 2017-07-20
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