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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.

Dillner, Joakim LU ; Kjaer, Susanne K; Wheeler, Cosette M; Sigurdsson, Kristján; Iversen, Ole-Erik; Hernandez-Avila, Mauricio; Perez, Gonzalo; Brown, Darron R; Koutsky, Laura A and Tay, Eng Hseon, et al. (2010) In BMJ (Clinical research ed.) 341.
Abstract
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... (More)
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. TRIAL REGISTRATIONS: NCT00092521 and NCT00092534. (Less)
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Vaginal Neoplasms: prevention & control, Uterine Cervical Neoplasms: prevention & control, Urogenital Neoplasms: prevention & control, Papillomavirus Infections: prevention & control, Condylomata Acuminata: prevention & control, Carcinoma in Situ: prevention & control, Cervical Intraepithelial Neoplasia: prevention & control, Vulvar Neoplasms: prevention & control
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BMJ (Clinical research ed.)
volume
341
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BioMed Central
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  • WOS:000280411600005
  • PMID:20647284
  • Scopus:77955099933
ISSN
1468-5833
DOI
10.1136/bmj.c3493
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English
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093e1a6c-880e-45a9-947d-9596e2730fa2 (old id 1644664)
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http://www.ncbi.nlm.nih.gov/pubmed/20647284?dopt=Abstract
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2010-08-05 10:11:19
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2017-01-15 04:28:34
@article{093e1a6c-880e-45a9-947d-9596e2730fa2,
  abstract     = {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. TRIAL REGISTRATIONS: NCT00092521 and NCT00092534.},
  articleno    = {c3493},
  author       = {Dillner, Joakim and Kjaer, Susanne K and Wheeler, Cosette M and Sigurdsson, Kristján and Iversen, Ole-Erik and Hernandez-Avila, Mauricio and Perez, Gonzalo and Brown, Darron R and Koutsky, Laura A and Tay, Eng Hseon and García, Patricia and Ault, Kevin A and Garland, Suzanne M and Leodolter, Sepp and Olsson, Sven-Eric and Tang, Grace W K and Ferris, Daron G and Paavonen, Jorma and Lehtinen, Matti and Steben, Marc and Bosch, F Xavier and Joura, Elmar A and Majewski, Slawomir and Muñoz, Nubia and Myers, Evan R and Villa, Luisa L and Taddeo, Frank J and Roberts, Christine and Tadesse, Amha and Bryan, Janine T and Maansson, Roger and Lu, Shuang and Vuocolo, Scott and Hesley, Teresa M and Barr, Eliav and Haupt, Richard},
  issn         = {1468-5833},
  keyword      = {Vaginal Neoplasms: prevention & control,Uterine Cervical Neoplasms: prevention & control,Urogenital Neoplasms: prevention & control,Papillomavirus Infections: prevention & control,Condylomata Acuminata: prevention & control,Carcinoma in Situ: prevention & control,Cervical Intraepithelial Neoplasia: prevention & control,Vulvar Neoplasms: prevention & control},
  language     = {eng},
  publisher    = {BioMed Central},
  series       = {BMJ (Clinical research ed.)},
  title        = {Four year efficacy of prophylactic human papillomavirus quadrivalent vaccine against low grade cervical, vulvar, and vaginal intraepithelial neoplasia and anogenital warts: randomised controlled trial.},
  url          = {http://dx.doi.org/10.1136/bmj.c3493},
  volume       = {341},
  year         = {2010},
}