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High sustained efficacy of a prophylactic quadrivalent human papillomavirus types 6/11/16/18 L1 virus-like particle vaccine through 5 years of follow-up

Villa, L. L.; Costa, R. L. R.; Petta, C. A.; Andrade, R. P.; Paavonen, J.; Iversen, O-E; Olsson, S-E; Hoye, J.; Steinwall, Margareta LU and Riis-Johannessen, G., et al. (2006) In British Journal of Cancer 95(11). p.1459-1466
Abstract
Human papillomavirus (HPV) causes cervical, vulvar, and vaginal cancers, precancerous dysplasia, and genital warts. We report data for the longest efficacy evaluation to date of a prophylactic HPV vaccine. In total, 552 women (16-23 years) were enrolled in a randomised, placebo-controlled study of a quadrivalent HPV 6/11/16/18L1 virus-like-particle vaccine with vaccination at months 0, 2, and 6. At regular intervals through 3 years, subjects underwent gynaecologic examination, cervicovaginal sampling for HPV DNA, serum anti-HPV testing, and Pap testing, with follow-up biopsy as indicated. A subset of 241 subjects underwent two further years of follow-up. At 5 years post enrolment, the combined incidence of HPV 6/11/16/18-related persistent... (More)
Human papillomavirus (HPV) causes cervical, vulvar, and vaginal cancers, precancerous dysplasia, and genital warts. We report data for the longest efficacy evaluation to date of a prophylactic HPV vaccine. In total, 552 women (16-23 years) were enrolled in a randomised, placebo-controlled study of a quadrivalent HPV 6/11/16/18L1 virus-like-particle vaccine with vaccination at months 0, 2, and 6. At regular intervals through 3 years, subjects underwent gynaecologic examination, cervicovaginal sampling for HPV DNA, serum anti-HPV testing, and Pap testing, with follow-up biopsy as indicated. A subset of 241 subjects underwent two further years of follow-up. At 5 years post enrolment, the combined incidence of HPV 6/11/16/18-related persistent infection or disease was reduced in vaccine-recipients by 96% (two cases vaccine versus 46 placebo). There were no cases of HPV 6/11/16/18-related precancerous cervical dysplasia or genital warts in vaccine recipients, and six cases in placebo recipients (efficacy = 100%; 95% CI:12-100%). Through 5 years, vaccine-induced anti-HPV geometric mean titres remained at or above those following natural infection. In conclusion, a prophylactic quadrivalent HPV vaccine was effective through 5 years for prevention of persistent infection and disease caused by HPV 6/11/16/18. This duration supports vaccination of adolescents and young adults, which is expected to greatly reduce the burden of cervical and genital cancers, precancerous dysplasia, and genital warts. (Less)
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keywords
cervical, cancer, clinical trial, genital warts, cervical intraepithelial neoplasia (CIN), virus-like particles, human papillomavirus, prophylactic vaccine
in
British Journal of Cancer
volume
95
issue
11
pages
1459 - 1466
publisher
Nature Publishing Group
external identifiers
  • wos:000242745800002
  • scopus:33845273878
ISSN
1532-1827
DOI
10.1038/sj.bjc.6603469
language
English
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yes
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ba3e45e1-82f8-4617-abf2-f0506e64004d (old id 682329)
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2008-01-04 16:04:20
date last changed
2018-11-18 03:31:43
@article{ba3e45e1-82f8-4617-abf2-f0506e64004d,
  abstract     = {Human papillomavirus (HPV) causes cervical, vulvar, and vaginal cancers, precancerous dysplasia, and genital warts. We report data for the longest efficacy evaluation to date of a prophylactic HPV vaccine. In total, 552 women (16-23 years) were enrolled in a randomised, placebo-controlled study of a quadrivalent HPV 6/11/16/18L1 virus-like-particle vaccine with vaccination at months 0, 2, and 6. At regular intervals through 3 years, subjects underwent gynaecologic examination, cervicovaginal sampling for HPV DNA, serum anti-HPV testing, and Pap testing, with follow-up biopsy as indicated. A subset of 241 subjects underwent two further years of follow-up. At 5 years post enrolment, the combined incidence of HPV 6/11/16/18-related persistent infection or disease was reduced in vaccine-recipients by 96% (two cases vaccine versus 46 placebo). There were no cases of HPV 6/11/16/18-related precancerous cervical dysplasia or genital warts in vaccine recipients, and six cases in placebo recipients (efficacy = 100%; 95% CI:12-100%). Through 5 years, vaccine-induced anti-HPV geometric mean titres remained at or above those following natural infection. In conclusion, a prophylactic quadrivalent HPV vaccine was effective through 5 years for prevention of persistent infection and disease caused by HPV 6/11/16/18. This duration supports vaccination of adolescents and young adults, which is expected to greatly reduce the burden of cervical and genital cancers, precancerous dysplasia, and genital warts.},
  author       = {Villa, L. L. and Costa, R. L. R. and Petta, C. A. and Andrade, R. P. and Paavonen, J. and Iversen, O-E and Olsson, S-E and Hoye, J. and Steinwall, Margareta and Riis-Johannessen, G. and Andersson-Ellstrom, A. and Elfgren, K. and von Krogh, G. and Lehtinen, M. and Malm, C. and Tamms, G. M. and Giacoletti, K. and Lupinacci, L. and Railkar, R. and Taddeo, F. J. and Bryan, J. and Esser, M. T. and Sings, H. L. and Saah, A. J. and Barr, E.},
  issn         = {1532-1827},
  keyword      = {cervical,cancer,clinical trial,genital warts,cervical intraepithelial neoplasia (CIN),virus-like particles,human papillomavirus,prophylactic vaccine},
  language     = {eng},
  number       = {11},
  pages        = {1459--1466},
  publisher    = {Nature Publishing Group},
  series       = {British Journal of Cancer},
  title        = {High sustained efficacy of a prophylactic quadrivalent human papillomavirus types 6/11/16/18 L1 virus-like particle vaccine through 5 years of follow-up},
  url          = {http://dx.doi.org/10.1038/sj.bjc.6603469},
  volume       = {95},
  year         = {2006},
}