Four year efficacy of prophylactic human papillomavirus quadrivalent vaccine against low grade cervical, vulvar, and vaginal intraepithelial neoplasia and anogenital warts: randomised controlled trial.
(2010) In BMJ: British Medical Journal 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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https://lup.lub.lu.se/record/1644664
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- 2010
- type
- Contribution to journal
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- published
- subject
- keywords
- 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
- in
- BMJ: British Medical Journal
- volume
- 341
- article number
- c3493
- publisher
- BMJ Publishing Group
- external identifiers
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- wos:000280411600005
- pmid:20647284
- scopus:77955099933
- ISSN
- 1756-1833
- DOI
- 10.1136/bmj.c3493
- language
- English
- LU publication?
- yes
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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
- date added to LUP
- 2016-04-04 09:35:20
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- 2022-05-17 00:58:18
@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.}},
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 = {{1756-1833}},
keywords = {{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 = {{BMJ Publishing Group}},
series = {{BMJ: British Medical Journal}},
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 = {{https://lup.lub.lu.se/search/files/5364347/1660582.pdf}},
doi = {{10.1136/bmj.c3493}},
volume = {{341}},
year = {{2010}},
}