icon fsr

文献詳細

雑誌文献

臨床婦人科産科65巻10号

2011年10月発行

文献概要

今月の臨床 子宮頸癌─予防と妊孕性温存のための治療戦略 予防戦略

3.HPVワクチンの臨床試験成績update

著者: 吉川裕之1

所属機関: 1筑波大学大学院人間総合科学研究科婦人周産期医学

ページ範囲:P.1216 - P.1219

文献購入ページに移動
 臨床試験でHPVワクチンの予防効果が確認されたのは,HPV16/18の持続感染と前癌病変であるCIN2/3,AIS発生についてであり,未感染者には100%近い効果がある1, 2).臨床治験ではおよそ15~25歳を対象としているが,一般対象にワクチンを接種する場合に100%近い効果があると誤解してはならない.あくまでHPV16やHPV18に未感染の場合である.治験の対象は数万人に達するが,関連のある重篤な有害事象は皆無に近い.2価ワクチン(HPV16/18,サーバリクス®)と4価ワクチン(HPV6/11/16/18,ガーダシル®)がある.HPVワクチンの最新(2009年以降)臨床試験データや勧告について紹介する.

参考文献

1) The FUTURE II Study Group : Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Eng J Med 356 : 1915─1927, 2007
2) Paavonen J, Naud P, Salmeron J, et al : Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA) : final analysis of a double-blind, randomised study in young women. Lancet 374 : 301─314, 2009
3) Centers for Disease Control and Prevention (CDC) : FDA licensure of bivalent human papillomavirus vaccine (HPV2, Cervarix) for use in females and updated HPV vaccination recommendations from the advisory committee on Immunization Practices (ACIP). MMWR 59 : 626─629, 2010
4) Centers for Disease Control and Prevention (CDC) : FDA licensure of quadrivalent human papillomavirus vaccine (HPV4, Gardasil) for use in males and guidance from the advisory committee on immunization practices(ACIP). MMWR 59 : 630─632, 2010
5) Einstein MH, Baron M, Levin MJ, et al : Comparison of the immunogenicity and safety of CervarixTM and Gardasil® human papillomavirus (HPV) cervical cancer vaccines in healthy women aged 18─45 years. Hum Vaccines 5 : 702─716, 2009
6) Descamps D, Hardt K, Spiessens B, et al : Safety of human papillomavirus(HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention : a pooled analysis of 11 clinical trials. Human Vaccines 5 : 332─340, 2009
7) The GlaxoSmithKline Vaccine HPV-007 Study Group : Sustained efficacy and immunogenicity of the human papillomavirus(HPV)-16/18 AS04-adjuvanted vaccine : analysis of a randomised placebo-controlled trial up to 6.4 years. Lancet 374 : 1975─1985, 2009
8) David M-P, Van Herck K, Hardt K, et al : Long-term persistence of anti-HPV-16 and -18 antibodies induced by vaccination with the AS04-adjuvanted cervical cancer vaccine : modeling of sustained antibody responses. Gynecol Oncol 115(3 Suppl 1) : S1─6, 2009
9) Konno R, Dobbelaere K, Godeaux O, et al : Immunogenicity, reactogenicity and safety of human papillomavirus 16/18 AS04-adjuvanted vaccine in Japanese women : interim analysis of a phase II double-blind, randomized controlled trial at Month 7. Int J Gynecol Cancer 19 : 905─911, 2009
10) Konno R, Tamura S, Dobbelaere K, et al : Efficacy of human papillomavirus 16/18 AS04-adjuvanted vaccine in Japanese women aged 20 to 25 years : interim analysis of a phase 2 double-blind, randomized, controlled trial. Int J Gynecol Cancer 20 : 404─410, 2010
11) Konno R, Tamura S, Dobbelaere K, et al : Efficacy of human papillomavirus type 16/18 AS04-adjuvanted vaccine in Japanese women aged 20 to 25 years : final analysis of a phase 2 double-blind, randomized controlled trial. Int J Gynecol Cancer 20 : 847─855, 2010
12) 神谷 斎,奥谷まり絵 : 10~15歳の日本人健康女性を対象とした子宮頸癌予防ワクチンCervarixTM(HPV-16/18AS04アジュバントワクチン)の免疫原性と安全性の評価.小児臨床42 : 2451─2460, 2009
13) Konno R, Sasagawa T, Fukuda T, et al : Cost-effectiveness analysis of prophylactic cervical cancer vaccination in Japanese women. Int J Gynecol Cancer 20 : 385─392, 2010
14) Rowhani-Rahbar A, Mao C, Hughes JP, et al : Longer term efficacy of a prophylactic monovalent human papillomavirustype 16 vaccine. Vaccine 27 : 5612─5619, 2009
15) Brown DR, Kjaer SK, Sigurdsson K, et al : The Impact of quadrivalent human papillomavirus(HPV ; types 6, 11, 16, and 18) L1 virus-like particle vaccine on infection and disease due to oncogenic nonvaccine HPV types in generally HPV─naive women aged 16─26 years. J Infect Dis 199 : 926─935, 2009
16) The FUTURE I/II Study Group : Four year efficacy of prophylactic human papillomavirus quadrivalent vaccine against low grade cervical, vulvar, and vaginal intraepithelial neoplasia and anogenital warts : randomised controlled trial. BMJ 340 : c3493, 2010
17) Munoz N, Manalastas R Jr, Pitisuttithum P, et al : Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine in women aged 24─45 years : a randomised, double-blind trial. Lancet 373 : 1949─1957, 2009
18) Garland SM, Ault KA, Gall SA, et al : Pregnancy and infant outcomes in the clinical trials of a human papillomavirus type 6/11/16/18 vaccine. a combined analysis of five randomized controlled trials. Obstet Gynecol 114 : 1179─1188, 2009
19) Fairley CK, Hocking JS, Gurrin LC, et al : Rapid decline in presentations of genital warts after the implementation of a national quadrivalent human papillomavirus vaccination programme for young women. Sex Transm Infect 85 : 499─502, 2009
20) Donovan B, Franklin N, Guy R, et al : Quadrivalent human papillomavirus vaccination and trends in genital warts in Australia : analysis of national sentinel surveillance data. Lancet Infect Dis 11 : 39─44, 2010
21) Giuliano AR, Palefsky JM, Goldstone S et al : Efficacy of quadrivalent HPV vaccine against HPV infection and disease in males. N Engl J Med 364 : 401─411, 2011

掲載誌情報

出版社:株式会社医学書院

電子版ISSN:1882-1294

印刷版ISSN:0386-9865

雑誌購入ページに移動
icon up
あなたは医療従事者ですか?