교차 예방 효과를 포함한 자궁경부암 예방 백신들의 효과에 대한 최신 지견
Efficacy of human papillomavirus vaccines including cross protection: A review of recent evidence
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두 종류의 자궁경부암 예방 백신 (HPV vaccines)의 면역원성은 여러 임상 2상, 임상 3상 연구에 의하여 수만 명의 여성에서 탁월한 효과가 증명이 되었다. 현재 임상에서 사용되고 있는 두 종류의 자궁경부암 예방 백신은 모두 자궁경부암의 약 70%에서 발견이 되는 HPV-16, HPV-18형의 감염에 대한 예방을 목적으로 하고 있다. 이에 최근 나온 HPV 예방 백신을 이용한 무작위 임상-대조군 연구들을 분석하여 이들 예방 백신의 임상적 효과와 안전상, 면역원성에 대하여 정리하여 보았다. Bivalent HPV vaccine, quadrivalent HPV vaccine 모두 성적 접촉이 이루어지기 전의 소녀들에게 접종이 이루어질 경우, 탁월한 면역 원성과 각각 목적으로 하는 HPV형에 대하여 거의 완벽한 방어 효과와 안전성을 보였다. 최근의 논문 결과들에 의하면 이들 백신은 HPV-16, HPV-18형과 비슷한 항원 구조를 가지는 HPV형에 대하여 교차 예방 효과도 보이고 있다. Quadrivalent vaccine은 HPV-31형에 의한 cervical intraepithelial neoplasia (CIN) 2/3, adenocarcinoma in sutu에 대한 예방 효과가 있으며, bivalent HPV vaccine은 HPV-31, HPV-33, HPV-45형의 감염 및 이들 아형에 의한 CIN2 이상의 자궁경부 병변에 대하여 상당한 효과가 보고되었으며, 현재, 국내 뿐만 아니라 오스트렐리아와 이스라엘에서는 26세 이상의 여성에 대하여 등록이 되어 있다. 이들 두 예방 백신에 대하여 임상 권고안이 국내에서는 이미 대한 부인종양콜포스코피 학회에 의하여 제시되어 있다. HPV 예방 백신이 장기적으로 자궁경부암의 예방에 상당한 효과가 있을 것으로 기대되고 있으나, 백신 투여를 받는 여성이 늘어나는 시기에는 국내 자궁경부 검진 권고안에 대하여도 새로운 정립이 필요하며, 26세 이상이나 남성 등 특수 군에 대한 예방 효과를 분석하여 자궁경부암 예방 백신의 권고안도 지속적인 개정이 필요하게 된다.
Abstract
The efficacy and immunogenicity of human papillomavirus (HPV) vaccines has proven excellent in several phase 2 and phase 3 trials involving tens of thousand women. Two versions of HPV vaccine had been developed, both target HPV 16 and HPV 18, which involve approximately 70% of cervical cancer. We have summarized the recent review of all randomized controlled trials in which vaccines against HPV were compared with placebo regarding efficacy, safety, and immunogenicity. Both vaccines have an excellent safety profile, are highly immunogenic, and have atributed complete type specific protection against persistent infection and associated lesions in fully vaccinated girls and young women. Data strongly suggest that both vaccines can have a variable level of cross protection against HPV types genetically and antigenically-closely related to vaccine types. Demonstration of cross protection against combined endpoints [cervical intraepithelial neoplasia (CIN) 2/3 and adenocarcinoma in situ] for HPV-31 has been reached for the quadrivalent vaccine. Bivalent HPV vaccine showed significant type-specific cross-protection against CIN2+ associated with HPV-31, HPV-33, and HPV-45. The bivalent vaccine is also registered for above age 26 in Australia, Israel and Korea. In our country, we have already set up the clinical guideline of both vaccines. Although these prophylactic vaccination is likely to provide important gains in the prevention of cervical cancer, we should have need to establish the new screening guideline in post-vaccination period and to make next version of vaccination-guidelines related of specific subgroups of patients who would benefit from the vaccine (women older than 26 years, boys, and men).
참고문헌 (64)
- Parkin DM, "The global health burden of infection-associated cancers in the year 2002", Int JCancer, 118, pp.3030~3044 (2006)
- de Villiers EM, "Classification of papillomaviruses", Virology, 324, pp.17~27 (2004)
- "Human papillomavirus and HPV vaccines: technical information for policy-makers and health professionals"[URL]
- Dunne EF, "Prevalence of HPV infection among females in the United States", JAMA, 297, pp.813~819 (2007)
- Dunne EF, "Prevalence of HPV infection among men: a systematic review of the literature", J Infect Dis, 194, pp.1044~1057 (2006)
- Stanley M, "Immune response to human papillomavirus", Vaccine, 24(1), pp.16~22 (2006)
- Clifford G, "Chapter 3: HPV type-distribution in women with and without cervical neoplastic diseases", Vaccine, 24(3), pp.3~34 (2006)
- Parkin DM, "Chapter 2: the burden of HPV-related cancers", Vaccine, 24(3), pp.3~25 (2006)
- Hai-Rim Shin, "National Cancer Incidence for the Year 2002 in Korea", Cancer Research and Treatment, 39(4), pp.139~149 (2007), 대한암학회
- Chung HH, "Cervical cancer incidence and survival in Korea: 1993-2002", Int J Gynecol Cancer, 16, pp.1833~1838 (2006)
- Howley PM, "Papillomaviridae: the viruses and their replication. In Fields virology. 3rd ed", pp.947~978 (1996), Lippincott-Raven Publishers
- Cripe TP, "Transcriptional regulation of the human papillomavirus-16 E6-E7 promoter by a keratinocyte- dependent enhancer, and by viral E2 trans-activator and repressor gene products: implications for cervical carcinogenesis", EMBO J, 6, pp.3745~3753 (1987)
- Stubenrauch F, "Differential requirements for conserved E2 binding sites in the life cycle of oncogenic human papillomavirus type 31", J Virol, 72, pp.1071~1077 (1998)
- Scheffner M, "The E6 oncoprotein encoded by human papillomavirus types 16 and 18 promotes the degradation of p53", Cell, 63, pp.1129~1136 (1990)
- Werness BA, "Association of human papillomavirus types 16 and 18 E6 proteins with p53", Science, 248, pp.76~79 (1990)
- Dyson N, "The human papilloma virus-16 E7 oncoprotein is able to bind to the retinoblastoma gene product", Science, 243, pp.934~937 (1989)
- Münger K, "Complex formation of human papillomavirus E7 proteins with the retinoblastoma tumor suppressor gene product", EMBO J, 8, pp.4099~4105 (1989)
- Edmonds C, "A point mutational analysis of human papillomavirus type 16 E7 protein", J Virol, 63, pp.2650~2656 (1989)
- Weintraub SJ, "Mechanism of active transcriptional repression by the retinoblastoma protein", Nature, 375, pp.812~815 (1995)
- Berezutskaya E, "Differential regulation of the pocket domains of the retinoblastoma family proteins by the HPV16 E7 oncoprotein", Cell Growth Differ, 8, pp.1277~1286 (1997)
- Jewers RJ, "Regions of human papillomavirus type 16 E7 oncoprotein required for immortalization of human keratinocytes", J Virol, 66, pp.1329~1235 (1992)
- Wang J, "Both Rb and E7 are regulated by the ubiquitin proteasome pathway in HPV-containing cervical tumor cells", Oncogene, 20, pp.4740~4749 (2001)
- Davies R, "Human papillomavirus type 16 E7 associates with a histone H1 kinase and with p107 through sequences necessary for transformation", J Virol, 67, pp.2521~2528 (1993)
- Funk JO, "Stillman B,Galloway DA. Inhibition of CDK activity and PCNA-dependent DNA replication by p21 is blocked by interaction with the HPV-16 E7 oncoprotein", Genes Dev, 11, pp.2090~2100 (1997)
- Jones DL, "The human papillomavirus E7 oncoprotein can uncouple cellular differentiation and proliferation in human keratinocytes by abrogating p21Cip1-mediated inhibition of cdk2", Genes Dev, 11, pp.2101~2011 (1997)
- Ruesch MN, "Human papillomavirus oncoproteins alter differentiation-dependent cell cycle exit on suspension in semisolid medium", Virology, 250, pp.19~29 (1998)
- Tommasino M, "HPV16 E7 protein associates with the protein kinase p33CDK2 and cyclin A", Oncogene, 8, pp.195~202 (1993)
- Zerfass-Thome K, "Inactivation of the cdk inhibitor p27KIP1 by the human papillomavirus type 16 E7 oncoprotein", Oncogene, 13, pp.2323~2330 (1996)
- Brehm A, "Retinoblastoma protein recruits histone deacetylase to repress transcription", Nature, 391, pp.597~601 (1998)
- Inglis S, "Chapter 11: HPV vaccines: commercial research & development", Vaccine, 24(3), pp.3~99 (2006)
- Ruiz W, "Kinetics and isotype profile of antibody responses in rhesus macaques induced following vaccination with HPV 6, 11, 16 and 18 L1-virus-like particles formulated with or without Merck aluminum adjuvant", J Immune Based Ther Vaccines, 3, pp.2~ (2005)
- Ismaili J, "Monophosphoryl lipid A activates both human dendritic cells and T cells", J Immunol, 168, pp.926~932 (2002)
- Einstein MH, "On behalf of the HPV-010 Study group. Immune response after primary vaccination course: a comparative trial of two prophylactic vaccines", 25th International Papillomavirus Conference (2009)
- 박종섭, "한국 젊은 여성의 성생활 양상; HPV예방 백신 도입을 위한 예비 연구", Journal of Gynecologic Oncology, 18(3), pp.209~218 (2007), 대한부인종양콜포스코피학회
- 김병기, "대한부인종양ㆍ콜포스코피학회의 4가 인유두종 바이러스 백신 접종 권고안", Journal of Gynecologic Oncology, 18(4), pp.259~283 (2007), 대한부인종양콜포스코피학회
- FUTURE II Study Group, "Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions", N Engl J Med, 356, pp.1915~1927 (2007)
- Garland SM, "Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases", N Engl J Med, 356, pp.1928~1943 (2007)
- Paavonen J, "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, 2009, pp.374, 301~314
- Harper DM, "Sustained efficacy up to 4.5 years of a bivalent L1 virus-like particle vaccine against human papillomavirus types 16 and 18: follow-up from a randomised control trial", Lancet, 367, pp.1247~1255 (2006)
- Paavonen J, "Efficacy of a prophylactic adjuvanted bivalent L1 virus-like-particle vaccine against infection with human papillomavirus types 16 and 18 in young women: an interim analysis of a phase III double-blind, randomised controlled trial", Lancet, 369, pp.2161~2170 (2007)
- Villa LL, "High sustained efficacy of a prophylactic quadrivalent human papillomavirus types 6", 11, 18 L1 virus-like particle vaccine through 5 years of follow-up, pp.Br J Cancer, 2006[DOI]
- Garland SM, "Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases", N Engl J Med, 356, pp.1928~1943 (2007)
- FUTURE II Study Group, "Prophylactic effi cacy of a quadrivalent human papillomavirus (HPV) vaccine in women with virological evidence of HPV infection", JInfect Dis, 196, pp.1438~1446
- Ault KA, "Effect of prophylactic human papillomavirus L1 virus-like-particle vaccine on risk of cervical intraepithelial neoplasia grade 2, grade 3, and adenocarcinoma in situ: a combined analysis of four randomised clinical trials", Lancet, 369, pp.1861~1868 (2007)
- Joura EA, "Efficacy of a quadrivalent prophylactic human papillomavirus (types 6, 11, 16, and 18) L1 virus-like-particle vaccine against high-grade vulval and vaginal lesions: a combined analysis of three randomised clinical trials", Lancet, 369, pp.1693~1702 (2007)
- "on behalf of the male quadrivalent HPV vaccine efficacy trial study group. Efficacy of the quadrivalent HPV vaccine against HPV 6/11/16/18-related genital infection in young men"[URL]
- "on behalf of the male quadrivalent HPV vaccine efficacy trial study group. The efficacy of quadrivalent HPV (types 6/11/16/18) vaccine in reducing the incidence of HPV infection and HPV-related genital disease in young men/URL:"[URL]
- FUTURE II Study Group, "Prophylactic efficacy of a quadrivalent human papillomavirus (HPV) vaccine in women with virological evidence of HPV infection", J Infect Dis, 196, pp.1438~1446 (2007)
- Barr E, "Quadrivalent human papillomavirus vaccine", Clin Infect Dis, 45, pp.609~617 (2007)
- Wright TC, "Chapter 14: HPV vaccine introduction in industrialized countries", Vaccine, 24(3), pp.122~131 (2006)
- French KM, "Strategies for the introduction of humanpapillomavirus vaccination: modeling the optimum age- and sex-specific pattern of vaccination in Finland", Br J Cancer, 96, pp.514~518 (2007)
- Skinner SR, "Human papillomavirus vaccination for the preventionof cervical neoplasia: is it appropriate to vaccinatewomen older than 26?", Med J Aust, 188, pp.238~242 (2008)
- Harper D, "Sustained immunogenicity and high efficacy against HPV-16", 18 related cervical neoplasia: long-term follow up through 6.4 years in women vaccinated with Cervarix™ (GSK’s HPV 16, Gynecol Oncol, pp.2008, 109[DOI]
- Jenkins D, "A review of cross-protection against oncogenic HPV by an HPV-16", 18 AS04-adjuvanted cervical cancer vaccine: importance of virological and clinical endpoints and implications for mass vaccination in cervical cancer prevention, 2008, pp.110(3), 18~25
- "Guidelines to assure the quality, safety and efficacy of recombinant human papillomavirus virus-like particle vaccines"[URL]
- Brown DR, "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, pp.926~935 (2009)
- de Sanjose´ S, "Worldwide prevalence and genotype distribution of cervical human papillomavirus DNA in women with normal cytology: a meta-analysis", Lancet Infect Dis, 7, pp.453~459 (2007)
- Future III study group, "Safety, efficacy, immunogenicity of quadrivalent HPV vaccine (Gardasil) in women aged 24-45", 24th International Papillomavirus Congress (2007)
- Schwartz T, "Immune Response in Women up to 55 Years of Age Vaccinated With Cervarix, the HPV-16", 18 L1 ASO4 Vaccine Candidate, 2007
- Schwarz TF, "Immunogenicity and tolerability of an HPV-16", 18 AS04-adjuvanted prophylactic cervical cancer vaccine in women aged 15-55 years, 2009, pp.27, 581~587
- "WHO Weekly epidemiological record 2007;No.28/29:255-6/URL:"[URL]
