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Immunogenicity and Safety of a 9-Valent HPV Vaccine

Authors
 Pierre Van Damme  ;  Sven Eric Olsson  ;  Stanley Block  ;  Xavier Castellsague  ;  Glenda E. Gray  ;  Teobaldo Herrera  ;  Li-Min Huang  ;  Dong Soo Kim  ;  Punnee Pitisuttithum  ;  Joshua Chen  ;  Susan Christiano  ;  Roger Maansson  ;  Erin Moeller  ;  Xiao Sun  ;  Scott Vuocolo  ;  Alain Luxembourg 
Citation
 Pediatrics, Vol.136(1) : 28-39, 2015 
Journal Title
 Pediatrics 
ISSN
 0031-4005 
Issue Date
2015
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.
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/140551
Full Text
http://pediatrics.aappublications.org/content/136/1/e28.long
DOI
10.1542/peds.2014-3745
Appears in Collections:
1. Journal Papers (연구논문) > 1. College of Medicine (의과대학) > Dept. of Pediatrics (소아청소년과학교실)
Yonsei Authors
김동수(Kim, Dong Soo)
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