Immunogenicity and Safety of a 9-Valent HPV Vaccine.
Pediatrics
; 136(1): e28-39, 2015 Jul.
Article
em En
| MEDLINE
| ID: mdl-26101366
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 (boysyoung women or girlsyoung 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.
Texto completo:
1
Coleções:
01-internacional
Contexto em Saúde:
10_ODS3_salud_sexual_reprodutiva
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1_ASSA2030
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2_ODS3
Base de dados:
MEDLINE
Assunto principal:
Vacinação
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Infecções por Papillomavirus
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Alphapapillomavirus
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Vacinas contra Papillomavirus
Tipo de estudo:
Observational_studies
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Prevalence_studies
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Prognostic_studies
/
Risk_factors_studies
Limite:
Adolescent
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Adult
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Child
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Female
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Humans
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Male
Idioma:
En
Revista:
Pediatrics
Ano de publicação:
2015
Tipo de documento:
Article