Impact of Human Papillomavirus (HPV)-6/11/16/18 Vaccine on All HPV-Associated Genital Diseases in Young Women

Journal of the National Cancer Institute

Volumn 102, Issue 5, 2010, Pages 325-339

  Munoz, Nubia ^a   Kjaer, Susanne K ^b   Sigurdsson, Kristján ^c   Iversen, Ole Erik ^d,e   Hernandez Avila, Mauricio ^f   Wheeler, Cosette M ^g   Perez, Gonzalo ^h,i   Brown, Darron R ^j   Koutsky, Laura A ^k   Tay, Eng Hseon ^l   Garcia, Patricía J ^m   Ault, Kevin A ⁿ   Garland, Suzanne M ^o,p   Leodolter, Sepp ^q   Olsson, Sven Eric ^r   Tang, Grace W K ^s   Ferris, Daron G ^t   Paavonen, Jorma ^u   Steben, Marc ^v   Bosch, F Xavier ^w   Dillner, Joakim ^x   Huh, Warner K ^y   Joura, Elmar A ^q   Kurman, Robert J ^z   Majewski, Slawomir ^aa   Myers, Evan R ^ab   Villa, Luisa L ^ac   Taddeo, Frank J ⁱ   Roberts, Christine ⁱ   Tadesse, Amha ⁱ   Bryan, Janine T ⁱ   Lupinacci, Lisa C ⁱ   Giacoletti, Katherine E D ⁱ   Sings, Heather L ⁱ   James, Margaret K ⁱ   Hesley, Teresa M ⁱ   Barr, Eliav ⁱ   Haupt, Richard M ⁱ   more..

^a Instituto Nacional de Cancerología   (Colombia)

^b UNIVERSITY OF COPENHAGEN   (Denmark)

^c ICELANDIC CANCER SOCIETY   (Iceland)

^d UNIVERSITY OF BERGEN   (Norway)

^e HAUKELAND UNIVERSITY HOSPITAL   (Norway)

^f INSTITUTO NACIONAL DE SALUD PÚBLICA   (Mexico)

^g UNIVERSITY OF NEW MEXICO HEALTH SCIENCES CENTER   (United States)

^h UNIVERSIDAD DEL ROSARIO   (Colombia)

ⁱ MERCK RESEARCH LABORATORIES   (United States)

^j INDIANA UNIVERSITY SCHOOL OF MEDICINE   (United States)

^k UNIVERSITY OF WASHINGTON   (United States)

^l KK WOMEN'S AND CHILDREN'S HOSPITAL   (Singapore)

^m UNIVERSIDAD PERUANA CAYETANO HEREDIA   (Peru)

ⁿ EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

^o ROYAL WOMEN'S HOSPITAL   (Australia)

^p UNIVERSITY OF MELBOURNE   (Australia)

^q MEDICAL UNIVERSITY OF VIENNA   (Austria)

^r DANDERYD HOSPITAL   (Sweden)

^s UNIVERSITY OF HONG KONG   (Hong Kong)

^t MEDICAL COLLEGE OF GEORGIA   (United States)

^u HELSINKI UNIVERSITY CENTRAL HOSPITAL   (Finland)

^v INSTITUT NATIONAL DE SANTÉ PUBLIQUE DU QUÉBEC   (Canada)

^w CATALAN INSTITUTE OF ONCOLOGY   (Spain)

^x LUND UNIVERSITY   (Sweden)

^y UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^z JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^aa MEDICAL UNIVERSITY OF WARSAW   (Poland)

^ab DUKE UNIVERSITY MEDICAL CENTER   (United States)

^ac LUDWIG INSTITUTE FOR CANCER RESEARCH   (Brazil)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALUMINUM HYDROXYPHOSPHATE SULFATE; IMMUNOLOGICAL ADJUVANT; PLACEBO; SILGARD; UNCLASSIFIED DRUG; WART VIRUS VACCINE;

ADENOCARCINOMA IN SITU; ADJUVANT THERAPY; ADOLESCENT; ADULT; ARTICLE; CARCINOMA IN SITU; CLINICAL TRIAL; COLPOSCOPY; CONDYLOMA ACUMINATUM; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; FEMALE; FOLLOW UP; GYNECOLOGIC DISEASE; HUMAN; HUMAN PAPILLOMAVIRUS TYPE 11; HUMAN PAPILLOMAVIRUS TYPE 16; HUMAN PAPILLOMAVIRUS TYPE 18; HUMAN PAPILLOMAVIRUS TYPE 6; HUMAN TISSUE; MAJOR CLINICAL STUDY; MULTICENTER STUDY; PAPANICOLAOU TEST; POPULATION EXPOSURE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RISK REDUCTION; UTERINE CERVIX CARCINOMA IN SITU; UTERINE CERVIX CYTOLOGY; VACCINATION; VAGINA CANCER; VAGINA INTRAEPITHELIAL NEOPLASIA; VULVA CANCER; VULVA INTRAEPITHELIAL NEOPLASIA;

ADOLESCENT; ADULT; ALPHAPAPILLOMAVIRUS; CERVICAL INTRAEPITHELIAL NEOPLASIA; FEMALE; GENITAL DISEASES, FEMALE; HUMAN PAPILLOMAVIRUS 11; HUMAN PAPILLOMAVIRUS 16; HUMAN PAPILLOMAVIRUS 18; HUMAN PAPILLOMAVIRUS 6; HUMANS; KAPLAN-MEIERS ESTIMATE; PAPILLOMAVIRUS INFECTIONS; PAPILLOMAVIRUS VACCINES; SEXUAL PARTNERS; SEXUALLY TRANSMITTED DISEASES; TUMOR VIRUS INFECTIONS; UTERINE CERVICAL NEOPLASMS; VAGINAL SMEARS; WORLD HEALTH; YOUNG ADULT;

EID: 77749279739     PISSN: 00278874     EISSN: 14602105     Source Type: Journal    
DOI: 10.1093/jnci/djp534     Document Type: Article

References (42)

1. Castellsague X de Sanjose S Aguado T et al. HPV and Cervical Cancer in the World. 2007 Report. WHO/ICO Information Centre on HPV and Cervical Cancer (HPV Information Centre). Geneva: WHO; Barcelona: ICO. http://www.who.int/ hpvcentre/en/. Accessed January 6, 2010.
2. Walboomers JMM, Jacobs MV, Manos MM, et al. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol. 1999; 189:12-19.
3. Muñoz N, Bosch FX, de Sanjosé S, et al. Epidemiologic classifcation of human papillomavirus types associated with cervical cancer. N Engl J Med. 2003;348(6):518-527. (Pubitemid 36159887)
4. Harper DM, Franco EL, Wheeler CM, et al. Sustained effcacy up to 4.5 years of a bivalent L1 virus-like particle vaccine against human papilloma-virus types 16 and 18: follow-up from a randomized control trial. Lancet. 2006;367(9518):1247-1255.
5. Harper DM. Impact of vaccination with Cervarix™ on subsequent HPV-16/18 infection and cervical disease in women 15-25 years of age. Gynecol Oncol. 2008;110:(3)(suppl 1):S11-S17.
6. Paavonen J, Jenkins D, Bosch FX, et al. Effcacy of a prophylactic adju-vanted 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. 2007;369(9580):2161-2170.
7. Garland SM, Hernandez-Avila M, Wheeler CM, et al. Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases. N Engl J Med. 2007;356(19):1928-1943. (Pubitemid 46740303)
8. The FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med. 2007;356(19):1915-1927
9. The FUTURE II Study Group. Effect of prophylactic human papilloma-virus L1 virus-like-particle vaccine on risk of cervical intraepithelial neo-plasia grade 2, grade 3 and adenocarcinoma in situ: a combined analysis of four randomised clinical trials. Lancet. 2007;369(9576):1861-1868.
10. Joura EA, Leodolter S, Hernandez-Avila M, et al. Effcacy 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 clinical trials. Lancet. 2007;369(9574):1693-1702.
11. Sankaranarayanan R, Nene BM, Shastri SS, et al. HPV screening for cervical cancer in rural India. N Engl J Med. 2009;360(14):1385-1394.
12. Coupe VM, Berkhof J, Bulkmans NW, Snijders PJ, Meijer CJ. Age-dependent prevalence of 14 high-risk HPV types in the Netherlands: implications for prophylactic vaccination and screening. Br J Cancer. 2008;98(3):646-651
13. IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. Vol 90. Human Papillomavirus, International Agency for Research on Cancer. Lyon, France: IARC press; 2007. http:monographs.iarc.fr/ENG /Monographs/vol90/index. php. Accessed August 28, 2008.
14. Reisinger KS, Block SL, Lazcano-Ponce E, et al. Safety and persistent immunogenicity of a quadrivalent human papillomavirus types 6, 11, 16, 18 L1 virus-like particle vaccine in preadolescents and adolescents: a randomized controlled trial. Ped Infect Dis J. 2007;26(3):201-209.
15. Block SL, Nolan T, Sattler C, et al. Comparison of the immunogenicity and reactogenicity of a prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in male and female adolescents and young adult women. Pediatrics. 2006;118(5):2135-2145.
16. Block S, Brown D, Chatterjee A, et al. Clinical trial and post-licensure safety profle of a prophylactic human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine [published online ahead of print November 30, 2009]. Ped Infect Dis J. doi: 10.1097/INF. 0b013e3181b77906.
17. The FUTURE II Study Group. Prophylactic effcacy of a quadrivalent human papillomavirus (HPV) vaccine in women with virologic evidence of HPV infection. J Infect Dis. 2007;196(10):1438-1446.
18. Wheeler C, Kjaer SK, Sigurdsson K, et al. The impact of quadrivalent HPV (type 6/11/16/18) L1 VLP vaccine on infection and disease due to oncogenic non-vaccine HPV types in sexually active women aged 16-26. J Infect Dis. 2009;199(7):936-944.
19. Brown DR, Kjaer SK, Sigurdsson K, et al. The impact of quadrivalent HPV (type 6/11/16/18) L1 VLP vaccine on infection and disease due to oncogenic non-vaccine HPV types in generally HPV naive women aged 16-26. J Infect Dis. 2009;199(7):926-935.
20. Villa LL, Costa RLR, Petta CA, et al. 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 effcacy trial. Lancet Oncol. 2005;6(5):271-278.
21. Henry MR. The Bethesda System 2001: an update of new terminology for gynecologic cytology. Clin Lab Med. 2003;23(3):585-603.
22. Sideri M, Jones RW, Wilkinson EJ, et al. Squamous vulvar intraepithelial neoplasia: 2004 modifed terminology, ISSVD Vulvar Oncology Subcommittee. J Reprod Med. 2005;50(11):807-810.
23. Opalka D, Lachman CE, MacMullen SA, et al. Simultaneous quantitation of antibodies to neutralizing epitopes on virus-like particles for human papillomavirus types 6, 11, 16 and 18 by a multiplexed luminex assay. Clin Diagn Lab Immunol. 2003;10(1):108-115.
24. Palker TJ, Monteiro JM, Martin MM, et al. Antibody, cytokine and cyto-toxic T lymphocyte responses in chimpanzees immunized with human papillomavirus virus-like particles. Vaccine. 2001;19(27):3733-3743.
25. Dias D, Van Doren J, Schlottmann S, et al. Optimization and validation of a multiplexed luminex assay to quantify antibodies to neutralizing epitopes on human papillomavirus 6, 11, 16 and 18. Clin Diagn Lab Immunol. 2005;12(8):959-969.
26. International patent numbers WO 2003/019143 A2 (Merck, Jansen, Taddeo, Li, Dicello, Fluorescent Multiplex HPV PCR Assays Using Multiple Fluorophores. March 6, 2003), WO 2006/116276 A2 (Merck, Taddeo, Skulsky, Wang, Jansen, Real-Time HPV PCR Assays. November 2, 2006), and WO 2006/116303 A2 (Merck, Taddeo, Skulsky, Wang, Jansen, Fluorescent Multiplex HPV PCR Assays. November 2, 2006). http://www.wipo.int/portal/index.html.en. Accessed January 5, 2010.
27. Mao C, Koutsky LA, Ault KA, et al. Effcacy of human papillomavirus-16 vaccine to prevent cervical intraepithelial neoplasia: a randomized controlled trial. Obstet Gynecol. 2006;107(1):18-27.
28. Chan ISF, Bohidar NR. Exact power and sample size for vaccine effcacy studies. Commun Stat Theory Methods. 1998;27:1305-1322.
29. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc. 1958;53:457-481.
30. Kjaer SK, Sigurdsson K, Iversen O-E, et al. A pooled analysis of continued prophylactic effcacy of quadrivalent HPV (types 6/11/16/18) vaccine against high-grade cervical and external genital lesions. Cancer Prev Res. 2009;2(10):868-878.
31. Sigurdsson K, Sigvaldason H, Gudmundsdottir T, Sigurdsson R, Briem H. The effcacy of HPV 16/18 vaccines on sexually active 18-23 year old women and the impact of HPV vaccination on organized cervical cancer screening. Acta Obstet Gynecol Scand. 2009;88(1):27-35.
32. Clifford G, Franceschi S, Diaz M, Munoz N, Villa LL. Chapter 3: HPV type-distribution in women with and without cervical neoplastic diseases. Vaccine. 2006;24:(suppl 3):S3/S26-S34.
33. Kodner CM, Nasraty S. Management of genital warts. Am Fam Physician. 2004;70(12):2335-2342.
34. Garland SM. Warts, genital. In: Speight TM, eds. Mimes Disease Index. 2nd ed. New South Wales, Australia: Division of Intercontinental Medical Statistics PTY Ltd; 1996:600-602.
35. Olsson S-E, Villa LL, Costa R, et al. Induction of immune memory following administration of a prophylactic quadrivalent human papilloma-virus (HPV) types 6/11/16/18 L1 virus-like-particle vaccine. Vaccine. 2007;25:4931-4939.
36. Olsson S-E, Kjaer SK, Sigurdsson K, et al. Evaluation of quadrivalent HPV 6/11/16/18 vaccine effcacy against cervical and anogenital disease in subjects with serological evidence of prior vaccine type HPV infection [published online ahead of print]. Human Vaccines. 2009;5(10). In press.
37. Garland SM, Steben M, Sings HL, et al. Natural history of genital warts: analysis of the placebo arm of 2 randomized phase III trials of a quadrivalent human papillomavirus (types 6, 11, 16, and 18) vaccine. J Infect Dis. 2009;199(6):805-814.
38. Kjaer SK, Breugelmans G, Munk C. Population-based prevalence, type-and age-specifc distribution of HPV in women before introduction of HPV-vaccination program in Denmark. Int J Cancer. 2008;123(8): 1864-1870.
39. Hughes JP, Garnett GP, Koutsky L. The theoretical population-level impact of a prophylactic human papilloma virus vaccine. Epidemiology. 2002;13(6):631-639.
40. Chan SY, Delius H, Halpern AL, Bernard HU. Analysis of genomic sequences of 95 papillomavirus types: uniting typing, phylogeny, and taxonomy. J Virol. 1995;69(5):3074-3083.
41. Centers for Disease Control and Prevention. Why it's Important to Monitor Vaccine Safety. http://www.cdc.gov/vaccinesafety/Vaccine-Monitoring/ Index.html. Accessed May 1 2010.
42. Dillner J, Arbyn M, Dillner L. Translational mini-review series on vaccines: monitoring of human papillomavirus vaccination. Clin Exp Immunol. 2007;148(2):199-207.