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Title
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Immunogenicity and safety of a 9-valent HPV vaccine
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Author
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Abstract
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| 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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Language
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English
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Source (journal)
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Pediatrics / American Academy of Pediatrics [Elk Grove Village, Ill.] - Evanston, Ill., 1948, currens
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Publication
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Evanston, Ill.
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2015
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ISSN
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0031-4005
[print]
1098-4275
[online]
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DOI
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10.1542/PEDS.2014-3745
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Volume/pages
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136
:1
(2015)
, p. E28-E39
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ISI
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000357296000004
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Pubmed ID
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26101366
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Full text (Publisher's DOI)
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Full text (publisher's version - intranet only)
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