Efficacy of a quadrivalent prophylactic human papillomavirus (types 6, 11, 16, and 18) L1 virus-like-particle vaccine against high-grade vulval and vaginal lesions: a combined analysis of three randomised clinical trials

Joura, Elmar A.; Leodolter, Sepp; Hernández-Ávila, Mauricio; Wheeler, Cosette M.; Pérez, Gonzalo; Koutsky, Laura A.; Garland, Suzanne M.; Harper, Diane M.; Tang, Grace; Ferris, Daron G.; Steben, Marc; Jones, Ronald W.; Bryan, Janine T.; Taddeo, Frank J.; Bautista, Oliver; Esser, Mark T.; Sings, Heather L.; Nelson, Micki; Boslego, John W.; Sattler, Carlos A.; Barr, Eliav; Paavonen, Jorma

doi:10.1016/s0140-6736(07)60777-6

Cited by 520 publications

(317 citation statements)

References 38 publications

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“…Differences between vaccine efficacy in the per-protocol and intention-to-treat populations imply that the maximum impact from prophylactic HPV vaccination programs will be achieved in women susceptible to infection and disease related to vaccine HPV types (those not previously exposed), as has previously been suggested (20)(21)(22). The vaccine is prophylactic and is not expected to have a therapeutic effect on current HPV infection (HPV DNA positivity) or high-grade intraepithelial lesions/cancer.…”

Section: Discussionmentioning

confidence: 99%

A Pooled Analysis of Continued Prophylactic Efficacy of Quadrivalent Human Papillomavirus (Types 6/11/16/18) Vaccine against High-grade Cervical and External Genital Lesions

Kjær

Sigurðsson

Iversen

et al. 2009

Cancer Prevention Research

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279

133

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Quadrivalent human papillomavirus (HPV) vaccine has been shown to provide protection from HPV 6/11/16/18-related cervical, vaginal, and vulvar disease through 3 years. We provide an update on the efficacy of the quadrivalent HPV vaccine against high-grade cervical, vaginal, and vulvar lesions based on end-of-study data from three clinical trials. Additionally, we stratify vaccine efficacy by several baseline characteristics, including age, smoking status, and Papanicolaou (Pap) test results. A total of 18,174 females ages 16 to 26 years were randomized and allocated into one of three clinical trials (protocols 007, 013, and 015). Vaccine or placebo was given at baseline, month 2, and month 6. Pap testing was conducted at regular intervals. Cervical and anogenital swabs were collected for HPV DNA testing. Examination for the presence of vulvar and vaginal lesions was also done. Endpoints included high-grade cervical, vulvar, or vaginal lesions (CIN 2/3, VIN 2/3, or VaIN 2/3). Mean follow-up time was 42 months post dose 1. Vaccine efficacy against HPV 6/11/16/18-related high-grade cervical lesions in the per-protocol and intention-to-treat populations was 98.2% [95% confidence interval (95% CI), 93.3-99.8] and 51.5% (95% CI, 40.6-60.6), respectively. Vaccine efficacy against HPV 6/11/16/18-related high-grade vulvar and vaginal lesions in the per-protocol and intention-to-treat populations was 100.0% (95% CI, 82.6-100.0) and 79.0% (95% CI, 56.4-91.0), respectively. Efficacy in the intention-to-treat population tended to be lower in older women, women with more partners, and women with abnormal Pap test results. The efficacy of quadrivalent HPV vaccine against high-grade cervical and external anogenital neoplasia remains high through 42 months post vaccination.

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Section: Discussionmentioning

confidence: 99%

A Pooled Analysis of Continued Prophylactic Efficacy of Quadrivalent Human Papillomavirus (Types 6/11/16/18) Vaccine against High-grade Cervical and External Genital Lesions

Kjær

Sigurðsson

Iversen

et al. 2009

Cancer Prevention Research

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279

133

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“…Nonetheless, some women in the population for whom the vaccines are approved will have been exposed to vaccine HPV types through sexual activity before vaccination. 5,6 Though there have been extensive data published on the efficacy of both vaccines, [7][8][9][10][11][12][13][14][15] less is known about the impact of HPV vaccination in women with ongoing HPV16 or 18 infections. Adequate knowledge of the HPV vaccines' impact on such women has important clinical implications, particularly with respect to HPV16 and HPV18, as several studies have shown that women who are persistently or chronically infected with cervical HPV16 or HPV18 are at considerably higher risk for developing high grade cervical lesions and cancer, compared with women positive for non-HPV16/18 oncogenic types, oncogenic HPV-negative women, or those transiently infected with HPV16/18.…”

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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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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“…24 On the other hand, absence of detectable antibodies does not automatically mean susceptibility to infection and HPV related diseases, especially in previously vaccinated individuals. [25][26][27] Among the 7.6 million people living in Quebec during the 2004-2007 period, 28 464 new cases of cancers of the cervix, vagina, vulva, anus and oropharynx among women were reported annually. 29 The burden was lower among men, with a yearly average of 246 new cases of cancers involving the anus, penis and oropharynx.…”

Section: Epidemiology and Clinical Burden Of Hpv Among Msmmentioning

confidence: 99%

HPV Vaccination for MSM: Synthesis of the evidence and recommendations from the Québec Immunization Committee

Sauvageau

Dufour-Turbis

2015

Human Vaccines & Immunotherapeutics

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Diseases associated with the human papilloma virus (HPV) are particularly common among men who have sex with men (MSM). Unlike heterosexual men, MSM do not benefit from the herd protection provided by the vaccination of girls. In this review, we synthesize the available evidence on HPV vaccination for MSM. We also present the recommendations of the Quebec Immunization Committee (CIQ) in this regard, which are: to provide targeted vaccination for MSM up to 26 years of age and in-school vaccination of preadolescent boys since this is the best approach to take to have a real impact on the burden related to HPV in the MSM population and to provide direct protection for all men.

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Efficacy of a quadrivalent prophylactic human papillomavirus (types 6, 11, 16, and 18) L1 virus-like-particle vaccine against high-grade vulval and vaginal lesions: a combined analysis of three randomised clinical trials

Cited by 520 publications

References 38 publications

A Pooled Analysis of Continued Prophylactic Efficacy of Quadrivalent Human Papillomavirus (Types 6/11/16/18) Vaccine against High-grade Cervical and External Genital Lesions

A Pooled Analysis of Continued Prophylactic Efficacy of Quadrivalent Human Papillomavirus (Types 6/11/16/18) Vaccine against High-grade Cervical and External Genital Lesions

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

HPV Vaccination for MSM: Synthesis of the evidence and recommendations from the Québec Immunization Committee

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