Browsing by Author "Perez, Gonzalo"

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    Four year efficacy of prophylactic human papillomavirus quadrivalent vaccine against low grade cervical, vulvar, and vaginal intraepithelial neoplasia and anogenital warts: randomised controlled trial
    (BMJ Publishing Group, 2010-07-20) The FUTURE I/II Study Group; Dillner, Joakim; Kjaer, Susanne K.; Wheeler, Cosette M.; Sigurdsson, Kristján; Iversen, Ole-Erik; Hernandez-Avila, Mauricio; Perez, Gonzalo; Brown, Darron R.; Koutsky, Laura A.; Tay, Eng Hseon; García, Patricia; Ault, Kevin A.; Garland, Suzanne M.; Leodolter, Sepp; Olsson, Sven-Eric; Tang, Grace W.K.; Ferris, Daron G.; Paavonen, Jorma; Lehtinen, Matti; Steben, Marc; Bosch, Xavier; Joura, Elmar A.; Majewski, Slawomir; Muñoz, Nubia; Myers, Evan R.; Villa, Luisa L; Taddeo, Frank J.; Roberts, Christine; Tadesse, Amha; Bryan, Janine T.; Maansson, Roger; Lu, Shuang; Vuocolo, Scott; Hesley, Teresa M.; Barr, Eliav; Haupt, Richard; Medicine, School of Medicine
    Objectives To evaluate the prophylactic efficacy of the human papillomavirus (HPV) quadrivalent vaccine in preventing low grade cervical, vulvar, and vaginal intraepithelial neoplasias and anogenital warts (condyloma acuminata). Design Data from two international, double blind, placebo controlled, randomised efficacy trials of quadrivalent HPV vaccine (protocol 013 (FUTURE I) and protocol 015 (FUTURE II)). The trials were to be 4 years in length, and the results reported are from final study data of 42 months’ follow-up. Setting Primary care centres and university or hospital associated health centres in 24 countries and territories around the world. Participants 17 622 women aged 16-26 years enrolled between December 2001 and May 2003. Major exclusion criteria were lifetime number of sexual partners (>4), history of abnormal cervical smear test results, and pregnancy. Intervention Three doses of quadrivalent HPV vaccine (for serotypes 6, 11, 16, and 18) or placebo at day 1, month 2, and month 6. Main outcome measures Vaccine efficacy against cervical, vulvar, and vaginal intraepithelial neoplasia grade I and condyloma in a per protocol susceptible population that included subjects who received all three vaccine doses, tested negative for the relevant vaccine HPV types at day 1 and remained negative through month 7, and had no major protocol violations. Intention to treat, generally HPV naive, and unrestricted susceptible populations were also studied. Results In the per protocol susceptible population, vaccine efficacy against lesions related to the HPV types in the vaccine was 96% for cervical intraepithelial neoplasia grade I (95% confidence interval 91% to 98%), 100% for both vulvar and vaginal intraepithelial neoplasia grade I (95% CIs 74% to 100%, 64% to 100% respectively), and 99% for condyloma (96% to 100%). Vaccine efficacy against any lesion (regardless of HPV type) in the generally naive population was 30% (17% to 41%), 75% (22% to 94%), and 48% (10% to 71%) for cervical, vulvar, and vaginal intraepithelial neoplasia grade I, respectively, and 83% (74% to 89%) for condyloma. Conclusions Quadrivalent HPV vaccine provided sustained protection against low grade lesions attributable to vaccine HPV types (6, 11, 16, and 18) and a substantial reduction in the burden of these diseases through 42 months of follow-up.
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    Human papillomavirus detection in cervical neoplasia attributed to 12 high-risk human papillomavirus genotypes by region
    (Elsevier, 2016-12) Castellsagué, Xavier; Ault, Kevin A.; Bosch, F. Xavier; Brown, Darron; Cuzick, Jack; Ferris, Daron G.; Jours, Elmar A.; Garland, Suzanne M.; Giuliano, Anna R.; Hernandez-Avila, Mauricio; Huh, Warner; Iversen, Ole-Erik; Kjaer, Susanne K.; Luna, Joaquin; Monsonego, Joseph; Muñoz, Nubia; Myers, Evan; Paavonen, Jorma; Pitisuttihum, Punnee; Steben, Marc; Wheeler, Cosette M.; Perez, Gonzalo; Saah, Alfred; Luxembourg, Alain; Sings, Heather L.; Velicer, Christine; Department of Medicine, IU School of Medicine
    Background We estimated the proportion of cervical intraepithelial neoplasia (CIN) cases attributed to 14 HPV types, including quadrivalent (qHPV) (6/11/16/18) and 9-valent (9vHPV) (6/11/16/18/31/33/45/52/58) vaccine types, by region Methods Women ages 15–26 and 24–45 years from 5 regions were enrolled in qHPV vaccine clinical trials. Among 10,706 women (placebo arms), 1539 CIN1, 945 CIN2/3, and 24 adenocarcinoma in situ (AIS) cases were diagnosed by pathology panel consensus. Results Predominant HPV types were 16/51/52/56 (anogenital infection), 16/39/51/52/56 (CIN1), and 16/31/52/58 (CIN2/3). In regions with largest sample sizes, minimal regional variation was observed in 9vHPV type prevalence in CIN1 (~50%) and CIN2/3 (81–85%). Types 31/33/45/52/58 accounted for 25–30% of CIN1 in Latin America and Europe, but 14–18% in North America and Asia. Types 31/33/45/52/58 accounted for 33–38% of CIN2/3 in Latin America (younger women), Europe, and Asia, but 17–18% of CIN2/3 in Latin America (older women) and North America. Non-vaccine HPV types 35/39/51/56/59 had similar or higher prevalence than qHPV types in CIN1 and were attributed to 2–11% of CIN2/3. Conclusions The 9vHPV vaccine could potentially prevent the majority of CIN1-3, irrespective of geographic region. Notwithstanding, non-vaccine types 35/39/51/56/59 may still be responsible for some CIN1, and to a lesser extent CIN2/3.
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    Prevalence, incidence, and natural history of HPV infection in adult women ages 24 to 45 participating in a vaccine trial
    (Elsevier, 2020-05-25) Ferris, Daron G.; Brown, Darron R.; Giuliano, Anna R.; Myers, Evan; Joura, Elmar A.; Garland, Suzanne M.; Kjaer, Susanne K.; Perez, Gonzalo; Saah, Alfred; Luxembourg, Alain; Velicer, Christine; Medicine, School of Medicine
    Objectives The natural history of human papillomavirus (HPV) infection has been studied extensively in young women; this study investigated HPV infection in adult women. Methods Data from 3817 women aged 24–45 years in a global trial of the 4-valent HPV (6/11/16/18) vaccine were used to calculate prevalence of anogenital infections containing 9-valent (9v) HPV vaccine types (6/11/16/18/31/33/45/52/58) and five non-vaccine types (35/39/51/56/59). Incidence of infections and persistent infections was estimated for 989 placebo recipients naive to all 14 HPV types at baseline. Age-adjusted hazard ratios were calculated for various sociodemographic factors. Results Prevalence of anogenital infection was highest in France at 29.2% (9vHPV types) and 21.7% (non-vaccine types) and lowest in the Philippines at 7.6% (9vHPV types) and 5.1% (non-vaccine types). Overall, HPV incidence (per 100 person-years) was 5.2 (9vHPV types) and 4.7 (non-vaccine types), and incidence of persistent infection was 2.7 (9vHPV types) and 2.1 (non-vaccine types). Factors associated with new HPV infections included younger age, younger age at first intercourse, being single, current use of tobacco, and higher number of past and recent sex partners. Conclusions Because mid-adult women acquire new HPV infections, administration of the 9vHPV vaccine could reduce HPV-related morbidity and mortality in this population.