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Prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in young women: a randomised double-blind placebo-controlled multicentre phase II efficacy trial

Villa, LL; Costa, RLR; Petta, CA; Andrade, RP; Ault, KA; Giuliano, AR; Wheeler, CM; Koutsky, LA; Malm, C and Lehtinen, M, et al. (2005) In The Lancet Oncology 6(5). p.271-278
Abstract
Background A randomised double-blind placebo-controlled phase II study was done to assess the efficacy of a prophylactic quadrivalent vaccine targeting the human papillomavirus (HPV) types associated with 70% of cervical cancers (types 16 and 18) and with 90% of genital warts (types 6 and 11). Methods 277 young women (mean age 20.2 years [SD 1.7]) were randomly assigned to quadrivalent HPV (20 μ g type 6, 40 μ g type 11, 40 μ g type 16, and 20 μ g type 18) L1 virus-like-particle (VLP) vaccine and 275 (mean age 20.0 years [1.7]) to one of two placebo preparations at day 1, month 2, and month 6. For 36 months, participants underwent regular gynaecological examinations, cervicovaginal sampling for HPV DNA, testing for serum antibodies to HPV,... (More)
Background A randomised double-blind placebo-controlled phase II study was done to assess the efficacy of a prophylactic quadrivalent vaccine targeting the human papillomavirus (HPV) types associated with 70% of cervical cancers (types 16 and 18) and with 90% of genital warts (types 6 and 11). Methods 277 young women (mean age 20.2 years [SD 1.7]) were randomly assigned to quadrivalent HPV (20 μ g type 6, 40 μ g type 11, 40 μ g type 16, and 20 μ g type 18) L1 virus-like-particle (VLP) vaccine and 275 (mean age 20.0 years [1.7]) to one of two placebo preparations at day 1, month 2, and month 6. For 36 months, participants underwent regular gynaecological examinations, cervicovaginal sampling for HPV DNA, testing for serum antibodies to HPV, and Pap testing. The primary endpoint was the combined incidence of infection with HPV 6, 11, 16, or 18, or cervical or external genital disease (ie, persistent HPV infection, HPV detection at the last recorded visit, cervical intraepithelial neoplasia, cervical cancer, or external genital lesions caused by the HPV types in the vaccine). Main analyses were done per protocol. Findings Combined incidence of persistent infection or disease with HPV 6, 11, 16, or 18 fell by 90% (95% CI 71-97, p< 0.0001) in those assigned vaccine compared with those assigned placebo. Interpretation A vaccine targeting HPV types 6, 11, 16, 18 could substantially reduce the acquisition of infection and clinical disease caused by common HPV types. (Less)
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published
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The Lancet Oncology
volume
6
issue
5
pages
271 - 278
publisher
Elsevier
external identifiers
  • WOS:000229091400018
  • PMID:15863374
  • Scopus:20944448032
ISSN
1474-5488
DOI
10.1016/S1470-2045(05)70101-7
language
English
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yes
id
0e6c131c-f2e0-4699-af87-cfeb1569551b (old id 240028)
date added to LUP
2007-08-22 16:50:54
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2017-02-12 03:33:50
@article{0e6c131c-f2e0-4699-af87-cfeb1569551b,
  abstract     = {Background A randomised double-blind placebo-controlled phase II study was done to assess the efficacy of a prophylactic quadrivalent vaccine targeting the human papillomavirus (HPV) types associated with 70% of cervical cancers (types 16 and 18) and with 90% of genital warts (types 6 and 11). Methods 277 young women (mean age 20.2 years [SD 1.7]) were randomly assigned to quadrivalent HPV (20 μ g type 6, 40 μ g type 11, 40 μ g type 16, and 20 μ g type 18) L1 virus-like-particle (VLP) vaccine and 275 (mean age 20.0 years [1.7]) to one of two placebo preparations at day 1, month 2, and month 6. For 36 months, participants underwent regular gynaecological examinations, cervicovaginal sampling for HPV DNA, testing for serum antibodies to HPV, and Pap testing. The primary endpoint was the combined incidence of infection with HPV 6, 11, 16, or 18, or cervical or external genital disease (ie, persistent HPV infection, HPV detection at the last recorded visit, cervical intraepithelial neoplasia, cervical cancer, or external genital lesions caused by the HPV types in the vaccine). Main analyses were done per protocol. Findings Combined incidence of persistent infection or disease with HPV 6, 11, 16, or 18 fell by 90% (95% CI 71-97, p&lt; 0.0001) in those assigned vaccine compared with those assigned placebo. Interpretation A vaccine targeting HPV types 6, 11, 16, 18 could substantially reduce the acquisition of infection and clinical disease caused by common HPV types.},
  author       = {Villa, LL and Costa, RLR and Petta, CA and Andrade, RP and Ault, KA and Giuliano, AR and Wheeler, CM and Koutsky, LA and Malm, C and Lehtinen, M and Skjeldestad, FE and Olsson, SE and Steinwall, Margareta and Brown, DR and Kurman, R and Ronnett, BM and Stoler, MH and Ferenczy, A and Harper, DM and Tamms, GM and Yu, J and Lupinacci, L and Railkar, R and Taddeo, FJ and Jansen, KU and Esser, MT and Sings, HL and Saah, AJ and Lupinacci, L},
  issn         = {1474-5488},
  language     = {eng},
  number       = {5},
  pages        = {271--278},
  publisher    = {Elsevier},
  series       = {The Lancet Oncology},
  title        = {Prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in young women: a randomised double-blind placebo-controlled multicentre phase II efficacy trial},
  url          = {http://dx.doi.org/10.1016/S1470-2045(05)70101-7},
  volume       = {6},
  year         = {2005},
}