Immunogenicity of 2 Doses of HPV Vaccine in Younger Adolescents vs 3 Doses in Young Women

Dobson, Simon; McNeil, Shelly; Dionne, Marc; Dawar, Meena; Ogilvie, Gina; Krajden, Mel; Sauvageau, Chantal; Scheifele, David W.; Kollmann, Tobias R.; Halperin, Scott A.; Langley, Joanne M.; Bettinger, Julie A.; Singer, Joel; Money, Deborah; Miller, D R; Naus, Monika; Marra, Fawziah; Young, E. T.

doi:10.1001/jama.2013.1625

Cited by 378 publications

(315 citation statements)

References 22 publications

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“…45,49 In another study, administration of a 2-dose regimen of qHPV vaccine in girls 9 to 13 years of age induced anti-HPV GMTs that were noninferior to those elicited by administration of a 3-dose regimen in young women 16 to 26 years of age. 50 This finding supports that a 2-dose regimen with the 9vHPV vaccine may be an acceptable alternative, which is currently under study. Another study was conducted to assess the safety of the 9vHPV vaccine in previous recipients of a 3-dose regimen of qHPV vaccine.…”

Section: Discussionsupporting

confidence: 68%

Immunogenicity and Safety of a 9-Valent HPV Vaccine

et al. 2015

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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 genderneutral HPV vaccination programs in preadolescents and adolescents.WHAT'S KNOWN ON THIS SUBJECT: Prophylactic vaccination of young women 16 to 26 years of age with the 9-valent human papillomavirus (HPV)-like particle (9vHPV) vaccine prevents infection and disease with vaccine HPV types.WHAT THIS STUDY ADDS: 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 implementation of gender-neutral HPV vaccination programs in preadolescents and adolescents.

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Section: Discussionsupporting

confidence: 68%

Immunogenicity and Safety of a 9-Valent HPV Vaccine

et al. 2015

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“…37 Accounting for those who do not complete the vaccine series would necessitate assumptions regarding vaccine efficacy and duration of protection for those who receive only one or 2 doses. [38][39][40] More complex models are better suited than ours for examining issues related to vaccine protection with less than 3 doses. 41 Instead, we used the simplifying assumption of 100% series completion not only to facilitate the use of our simplified model but also to allow for an easier interpretation of our results regarding the cost-effectiveness of 9vHPV compared with 4vHPV.…”

Section: Vaccine Characteristicsmentioning

confidence: 99%

The impact and cost-effectiveness of nonavalent HPV vaccination in the United States: Estimates from a simplified transmission model

Chesson

Markowitz

Hariri

et al. 2016

Human Vaccines & Immunotherapeutics

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Introduction: The objective of this study was to assess the incremental costs and benefits of the 9-valent HPV vaccine (9vHPV) compared with the quadrivalent HPV vaccine (4vHPV). Like 4vHPV, 9vHPV protects against HPV types 6, 11, 16, and 18. 9vHPV also protects against 5 additional HPV types 31, 33, 45, 52, and 58. Methods: We adapted a previously published model of the impact and cost-effectiveness of 4vHPV to include the 5 additional HPV types in 9vHPV. The vaccine strategies we examined were (1) 4vHPV for males and females; (2) 9vHPV for females and 4vHPV for males; and (3) 9vHPV for males and females. In the base case, 9vHPV cost $13 more per dose than 4vHPV, based on available vaccine price information. Results: Providing 9vHPV to females compared with 4vHPV for females (assuming 4vHPV for males in both scenarios) was cost-saving regardless of whether or not cross-protection for 4vHPV was assumed. The cost per quality-adjusted life year (QALY) gained by 9vHPV for both sexes (compared with 4vHPV for both sexes) was < $0 (cost-saving) when assuming no cross-protection for 4vHPV and $8,600 when assuming cross-protection for 4vHPV. Conclusions: Compared with a vaccination program of 4vHPV for both sexes, a vaccination program of 9vHPV for both sexes can improve health outcomes and can be cost-saving.

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“…Recent data indicates that immune responses to the vaccine are greater when initiated before adolescence [34,35]. In addition, HPV antibody titers measured after HPV vaccination in women aged 16-26 years have been shown to be lower than those in younger women [36][37][38][39]. While we did not ascertain prior HPV exposure (eg, by serological analysis) for subjects who entered the study having received at least 1 dose, the associations between the age at vaccination and risk of anogenital HPV6/11/16/18 infection and cervical cytological abnormalities did not appear to be due to differences in sexual experience at time of vaccination.…”

Section: Discussionmentioning

confidence: 99%

“…Trials of extended dosing schedules (0, 12, and 24 months) have also shown lower antibody titers after vaccination, compared with shorter dosing schedules [34,36,37]. In addition, the number of vaccine doses and older age at vaccination have been shown to differentially influence T-and B-cell responses, respectively [34].…”

Section: Discussionmentioning

confidence: 99%

Risk of Delayed Human Papillomavirus Vaccination in Inner-City Adolescent Women

et al. 2016

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Background. Uptake of human papillomavirus (HPV) vaccine in the United States is slow, and the effectiveness of the vaccine has not been assessed in high-risk adolescent populations.Methods. We conducted a longitudinal study of 1139 sexually active, inner-city adolescent women receiving the 3-dose quadrivalent (4vHPV) vaccine. Cervical and anal specimens collected semiannually were tested using an L1-specific polymerase chain reaction assay. Postvaccination incidence of 4vHPV vaccine and nonvaccine HPV types, and risk of cervical cytological abnormalities, were assessed in relation to time to completion of all 3 vaccine doses.Results. Compared to vaccine naive women at enrollment, vaccinated women had significantly lower incidence rate ratios of cervical infection with HPV6/11/16/18 (0.2; 95% confidence interval [CI], .1-.4) and the related types HPV31 and HPV45 (0.4 [95% CI, .2-1.0] and 0.3 [95% CI, .1-.6], respectively), as well as significantly lower incidence rate ratios of anal infection with HPV6/11/16/18 (0.4; 95% CI, .2-.7). Notably, we observed higher risks of cervical HPV6/11/16/18 infection (hazards ratio [HR], 2.9; 95% CI, 1.0-8.0) and associated cytological abnormalities (HR, 4.5; 95% CI, .7-26.0) among women immunized at ≥15 years of age who took ≥12 months (vs <12 months) to complete the 3-dose regimen.Conclusions. Among adolescents immunized at ≥15 years of age, a longer time to complete the 3-dose schedule was associated with an increased risk of anogenital HPV6/11/16/18 infection and an increased incidence of associated cervical cytological abnormalities.

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Immunogenicity of 2 Doses of HPV Vaccine in Younger Adolescents vs 3 Doses in Young Women

Cited by 378 publications

References 22 publications

Immunogenicity and Safety of a 9-Valent HPV Vaccine

Immunogenicity and Safety of a 9-Valent HPV Vaccine

The impact and cost-effectiveness of nonavalent HPV vaccination in the United States: Estimates from a simplified transmission model

Risk of Delayed Human Papillomavirus Vaccination in Inner-City Adolescent Women

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