Evaluation of quadrivalent HPV 6/11/16/18 vaccine efficacy against cervical and anogenital disease in subjects with serological evidence of prior vaccine type HPV infection

Olsson, Sven Eric; Kjær, Susanne K.; Sigurðsson, Kristján; Iversen, Ole Erik; Hernández-Ávila, Mauricio; Wheeler, Cosette M.; Pérez, Gonzalo; Brown, Darron R.; Koutsky, Laura A.; Tay, Eng Hseon; García, Patricia J.; Ault, Kevin A.; Garland, Suzanne M.; Leodolter, Sepp; Tang, Grace; Ferris, Daron G.; Paavonen, Jorma; Lehtinen, Matti; Steben, Marc; Bosch, F. Xavier; Dillner, Joakim; Joura, Elmar A.; Majewski, Sławomir; Muñóz, Núbia; Myers, Evan R.; Villa, Luisa L.; Taddeo, Frank J.; Roberts, Christine C.; Tadesse, Amha; Bryan, Janine T.; Maansson, Roger; Vuocolo, Scott; Hesley, Teresa M.; Saah, Alfred J.; Barr, Eliav; Haupt, Richard M.

doi:10.4161/hv.5.10.9515

Cited by 188 publications

(136 citation statements)

References 15 publications

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“…1) 19,20 and prevents reinfection or reactivation of disease that is related to vaccine HPV types. 21 In contrast, the HPV6/11/16/18 vaccine does not impact progression of HPV16 or HPV18 infections to disease (i.e., there was no impact in women who were seronegative and DNA positive to HPV16 or HPV18). 12,13 We have previously reported interim data ($3 years of follow-up) on the impact of the HPV6/11/18/18 vaccine in women who were both seropositive and DNA positive to HPV16 or HPV18 at the time of the initial vaccination with the first dose (Fig.…”

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confidence: 99%

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Impact of an HPV6/11/16/18 L1 virus‐like particle vaccine on progression to cervical intraepithelial neoplasia in seropositive women with HPV16/18 infection

Haupt¹,

Wheeler²,

Brown

et al. 2011

Intl Journal of Cancer

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The impact of a human papillomavirus (HPV) vaccine on development of cervical intraepithelial neoplasia grade 2‐3 or adenocarcinoma in situ (CIN2‐3/AIS) in women with ongoing HPV16 or 18 infections prevaccination is reported. Seventeen thousand six‐hundred and twenty‐two women aged 16–26 were enrolled in 1 of 2 randomized, placebo‐controlled, efficacy trials (Protocols 013 and 015). Vaccine or placebo was given at day 1, month 2 and 6. Women were tested for HPV6/11/16/18 DNA and antibodies at day 1. We focus on the subset of women who were seropositive and DNA positive to HPV16 or HPV18 prevaccination. Incidence is expressed as the number of women with an endpoint per 100 person‐years‐at‐risk. In total, 419 vaccine and 446 placebo recipients were both seropositive and DNA positive to HPV16 or HPV18 prevaccination and had at least one follow‐up visit. In Protocol 013, the incidence of HPV16/18‐related CIN2‐3/AIS among these women was 10.9 in the vaccine arm and 7.0 in the placebo arm (vaccine efficacy = −54.9; 95% CI: −181.7, 13.0). In Protocol 015, the incidence of HPV16/18‐related CIN2‐3/AIS was 5.5 in the vaccine arm and 6.2 in the placebo arm (vaccine efficacy = 12.2%; 95% CI: −29.8, 40.9). These data suggest HPV vaccination neither reduces nor enhances progression to HPV16/18‐related high grade cervical lesions, and cervical cytology screening and corresponding management should continue as per local recommendations. Ultimately, population‐based surveillance of vaccinated individuals beyond these clinical trials will be required to further address questions regarding the impact of vaccination in women exposed to vaccine HPV types before vaccination.

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“…Seventeen thousand six-hundred and twenty-two women aged [16][17][18][19][20][21][22][23][24][25][26] were enrolled in 1 of 2 randomized, placebo-controlled, efficacy trials (Protocols 013 and 015). Vaccine or placebo was given at day 1, month 2 and 6.…”

mentioning

confidence: 99%

Impact of an HPV6/11/16/18 L1 virus‐like particle vaccine on progression to cervical intraepithelial neoplasia in seropositive women with HPV16/18 infection

Haupt¹,

Wheeler²,

Brown

et al. 2011

Intl Journal of Cancer

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“…1,2 Current recommendations are to vaccinate young adolescents prior to exposure, after which the vaccine may be much less efficacious. 3 However, catch-up vaccination is also underway for women up to the age of 26, and HPV coverage among adolescent females in the U.S.A. is lagging, with only one third having received the full threedose series. 4 Furthermore, while the prevalence of cervical HPV is at its highest in adolescent women, how this relates to other orifices involved in sex (i.e., anal canal and oral cavity) and to vaccine effectiveness in high-risk young women, is the focus of ongoing studies.…”

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confidence: 99%

Burden of Cervical, Anal, and Oral HPV in an Inner-City Pre-vaccine Adolescent Population

Rojas

Lorde-Rollins²,

Nucci-Sack³

et al. 2012

J Urban Health

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“…Whereas a reduced-dose regimen has been shown to be as effective among young vaccinees [14], current recommendations are to keep the 3-dose schedule if vaccination is initiated after the 15th birthday [15]. Moreover, the effectiveness of the vaccine may be further diminished by the fact that the efficacy of the vaccine is substantially reduced among populations with a past or present HPV infection [16,17] and that almost half (42%) of adolescent women in the United States are already sexually active by the 10th grade (ie, age 15-16 years) [18].…”

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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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Evaluation of quadrivalent HPV 6/11/16/18 vaccine efficacy against cervical and anogenital disease in subjects with serological evidence of prior vaccine type HPV infection

Cited by 188 publications

References 15 publications

Impact of an HPV6/11/16/18 L1 virus‐like particle vaccine on progression to cervical intraepithelial neoplasia in seropositive women with HPV16/18 infection

Impact of an HPV6/11/16/18 L1 virus‐like particle vaccine on progression to cervical intraepithelial neoplasia in seropositive women with HPV16/18 infection

Burden of Cervical, Anal, and Oral HPV in an Inner-City Pre-vaccine Adolescent Population

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

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