Sökning: onr:"swepub:oai:lup.lub.lu.se:093e1a6c-880e-45a9-947d-9596e2730fa2" >
Four year efficacy ...
Abstract
Ämnesord
Stäng
- 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.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Mikrobiologi inom det medicinska området (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Microbiology in the medical area (hsv//eng)
Nyckelord
- 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
Publikations- och innehållstyp
- art (ämneskategori)
- ref (ämneskategori)
Hitta via bibliotek
Till lärosätets databas
- Av författaren/redakt...
-
Dillner, Joakim
-
Kjaer, Susanne K
-
Wheeler, Cosette ...
-
Sigurdsson, Kris ...
-
Iversen, Ole-Eri ...
-
Hernandez-Avila, ...
-
visa fler...
-
Perez, Gonzalo
-
Brown, Darron R
-
Koutsky, Laura A
-
Tay, Eng Hseon
-
García, Patricia
-
Ault, Kevin A
-
Garland, Suzanne ...
-
Leodolter, Sepp
-
Olsson, Sven-Eri ...
-
Tang, Grace W K
-
Ferris, Daron G
-
Paavonen, Jorma
-
Lehtinen, Matti
-
Steben, Marc
-
Bosch, F Xavier
-
Joura, Elmar A
-
Majewski, Slawom ...
-
Muñoz, Nubia
-
Myers, Evan R
-
Villa, Luisa L
-
Taddeo, Frank J
-
Roberts, Christi ...
-
Tadesse, Amha
-
Bryan, Janine T
-
Maansson, Roger
-
Lu, Shuang
-
Vuocolo, Scott
-
Hesley, Teresa M
-
Barr, Eliav
-
Haupt, Richard
-
visa färre...
- Om ämnet
-
- MEDICIN OCH HÄLSOVETENSKAP
-
MEDICIN OCH HÄLS ...
-
och Medicinska och f ...
-
och Mikrobiologi ino ...
- Artiklar i publikationen
-
BMJ: British Med ...
-
BMJ
- Av lärosätet
-
Lunds universitet
-
Karolinska Institutet