Quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (Gardasil®): A review of its use in the prevention of premalignant anogenital lesions, cervical and anal cancers, and genital warts

Drugs

Volumn 74, Issue 11, 2014, Pages 1253-1283

  McCormack, Paul L ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

CAPSID PROTEIN; PLACEBO; WART VIRUS VACCINE; HUMAN PAPILLOMAVIRUS VACCINE L1, TYPE 6,11,16,18;

ADOLESCENT; ADULT; ANAPHYLAXIS; ANTIBODY DETECTION; ANUS CANCER; AUTOIMMUNE DISEASE; CANCER PREVENTION; CHILD; CONDYLOMA ACUMINATUM; CONVULSION; DEEP VEIN THROMBOSIS; DIZZINESS; DRUG EFFECT; DRUG TOLERABILITY; ERYTHEMA; FAINTNESS; FATIGUE; FEMALE; FEVER; GUILLAIN BARRE SYNDROME; HEADACHE; HUMAN; HUMAN PAPILLOMAVIRUS TYPE 11; HUMAN PAPILLOMAVIRUS TYPE 16; HUMAN PAPILLOMAVIRUS TYPE 18; HUMAN PAPILLOMAVIRUS TYPE 6; IMMUNOGENICITY; INJECTION SITE REACTION; LUNG EMBOLISM; MALE; NAUSEA; PRECANCER; REVIEW; SCHOOL CHILD; SEROCONVERSION; UTERINE CERVIX CANCER; ALPHAPAPILLOMAVIRUS; ANUS NEOPLASMS; CONDYLOMATA ACUMINATA; DRUG EFFECTS; PAPILLOMAVIRUS INFECTIONS; UTERINE CERVICAL NEOPLASMS;

ALPHAPAPILLOMAVIRUS; ANUS NEOPLASMS; CONDYLOMATA ACUMINATA; FEMALE; HUMANS; MALE; PAPILLOMAVIRUS INFECTIONS; PAPILLOMAVIRUS VACCINES; UTERINE CERVICAL NEOPLASMS;

EID: 84904640110     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.1007/s40265-014-0255-z     Document Type: Review

References (165)

1. Stanley M. Prophylactic HPV vaccines: prospects for eliminating ano-genital cancer. Br J Cancer. 2007;96(9):1320-3. (Pubitemid 46685776)
2. 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):2135-45. (Pubitemid 46393698)
3. Collins S, Mazloomzadeh S, Winter H, et al. High incidence of cervical human papillomavirus infection in women during their first sexual relationship. BJOG. 2002;109(1):96-8.
4. Winer RL, Lee SK, Hughes JP, et al. Genital human papillomavirus infection: incidence and risk factors in a cohort of female university students. Am J Epidemiol. 2003;157(3):218-26. (Pubitemid 36152435)
5. Winer RL, Kiviat NB, Hughes JP, et al. Development and duration of human papillomavirus lesions, after initial infection. J Infect Dis. 2005;191(5):731-8. (Pubitemid 40271061)
6. Munoz N, Bosch FX, Castellsague X, et al. Against which human papillomavirus types shall we vaccinate and screen? The international perspective. Int J Cancer. 2004;111(2):278-85. (Pubitemid 38924707)
7. Walboomers JM, Jacobs MV, Manos MM, et al. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol. 1999;189(1):12-9. (Pubitemid 29406813)
8. International Agency for Research on Cancer. GLOBOCAN 2012: estimated cancer incidence, mortality and prevalence worldwide in 2012. 2014. http://globocan.iarc.fr/Pages/fact-sheets-population.aspx. Accessed 8 April 2014.
9. Kreimer AR, Clifford GM, Boyle P, et al. Human papillomavirus types in head and neck squamous cell carcinomas worldwide: a systematic review. Cancer Epidemiol Biomark Prev. 2005;14(2):467-75. (Pubitemid 40270113)
10. Parkin DM, Bray F. Chapter 2: The burden of HPV-related cancers. Vaccine. 2006;24(Suppl 3):S3/11-25.
11. Parkin DM. The global health burden of infection-associated cancers in the year 2002. Int J Cancer. 2006;118(12):3030-44.
12. 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):805-14.
13. Lacey CJ, Lowndes CM, Shah KV. Chapter 4: Burden and management of non-cancerous HPV-related conditions: HPV-6/ 11 disease. Vaccine. 2006;24(Suppl 3):S3/35-41.
14. European Medicines Agency. Gardasil (human papillomavirus vaccine [types 6, 11, 16, 18], recombinant, adsorbed): summary of product characteristics. 2014. http://www.ema.europa.eu/ema/. Accessed 20 June 2014.
15. European Medicines Agency. Cervarix (human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed): summary of product characteristics. 2011. http://www.ema.europa.eu/ema/. Accessed 20 June 2014.
16. Garland SM, Smith JS. Human papillomavirus vaccines: current status and future prospects. Drugs. 2010;70(9):1079-98.
17. Villa LL, Costa RL, 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 efficacy trial. Lancet Oncol. 2005;6(5):271-8. (Pubitemid 40590263)
18. Villa LL, Ault KA, Giuliano AR, et al. Immunologic responses following administration of a vaccine targeting human papillomavirus types 6, 11, 16, and 18. Vaccine. 2006;24(27-28):5571-83. (Pubitemid 44172918)
19. 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):1928-43. (Pubitemid 46740303)
20. Joura EA, Kjaer SK, Wheeler CM, et al. HPV antibody levels and clinical efficacy following administration of a prophylactic quadrivalent HPV vaccine. Vaccine. 2008;26(52):6844-51.
21. The FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med. 2007;356(19):1915-27.
22. Olsson SE, Villa LL, Costa RL, et al. Induction of immune memory following administration of a prophylactic quadrivalent human papillomavirus (HPV) types 6/11/16/18 L1 virus-like particle (VLP) vaccine. Vaccine. 2007;25(26):4931-9. (Pubitemid 46843434)
23. 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. 2009;373(9679):1949-57.
24. Castellsagué X, Munoz N, Pitisuttithum P, et al. End-of-study safety, immunogenicity, and efficacy of quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine in adult women 24-45 years of age. Br J Cancer. 2011;105(1):28-37.
25. Giuliano AR, Palefsky JM, Goldstone S, et al. Efficacy of quadrivalent HPV vaccine against HPV infection and disease in males. N Engl J Med. 2011;364(5):401-11.
26. Dobson SR, McNeil S, Dionne M, et al. Immunogenicity of 2 doses of HPV vaccine in younger adolescents vs 3 doses in young women: a randomized clinical trial. JAMA. 2013;309(17):1793-802.
27. 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 papillomaviruses 6, 11, 16, and 18. Clin Diagn Lab Immunol. 2005;12(8):959-69.
28. Brown DR, Garland SM, Ferris DG, et al. The humoral response to Gardasil over four years as defined by total IgG and competitive Luminex immunoassay. Hum Vaccin. 2011;7(2):230-8.
29. Einstein MH, Baron M, Levin MJ, et al. Comparison of the immunogenicity and safety of Cervarix and Gardasil human papillomavirus (HPV) cervical cancer vaccines in healthy women aged 18-45 years. Hum Vaccin. 2009;5(10):705-19.
30. Einstein MH, Baron M, Levin MJ, et al. Comparative immunogenicity and safety of human papillomavirus (HPV)-16/18 vaccine and HPV-6/11/16/18 vaccine: follow-up from months 12-24 in a phase III randomized study of healthy women aged 18-45 years. Hum Vaccin. 2011;7(12):1343-58.
31. Draper E, Bissett SL, Howell-Jones R, et al. A randomized, observer-blinded immunogenicity trial of Cervarix® and Gardasil® human papillomavirus vaccines in 12-15 year old girls. PLoS One. 2013;8(5):e61825.
32. Roberts C, Swoyer R, Bryan J. Evaluation of the HPV 18 antibody response in Gardasil vaccinees after 48 months using a pseudovirion neutralization assay. Hum Vaccin Immunother. 2012;8(4):431-4.
33. Giuliano AR, Lazcano-Ponce E, Villa L, et al. Impact of baseline covariates on the immunogenicity of a quadrivalent (types 6, 11, 16, and 18) human papillomavirus virus-like-particle vaccine. J Infect Dis. 2007;196(8):1153-62. (Pubitemid 47580270)
34. Garland SM, Steben M, Hernandez-Avila M, et al. Noninferiority of antibody response to human papillomavirus type 16 in subjects vaccinated with monovalent and quadrivalent L1 virus-like particle vaccines. Clin Vaccine Immunol. 2007;14(6):792-5. (Pubitemid 47104771)
35. Smith JF, Brownlow M, Brown M, et al. Antibodies from women immunized with Gardasil cross-neutralize HPV 45 pseudovirions. Hum Vaccin. 2007;3(4):109-15. (Pubitemid 47501028)
36. 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. Pediatr Infect Dis J. 2007;26(3):201-9. (Pubitemid 46340765)
37. Li R, Li Y, Radley D, et al. Safety and immunogenicity of a vaccine targeting human papillomavirus types 6, 11, 16 and 18: a randomized, double-blind, placebo-controlled trial in Chinese males and females. Vaccine. 2012;30(28):4284-91.
38. Hillman RJ, Giuliano AR, Palefsky JM, et al. Immunogenicity of the quadrivalent human papillomavirus (type 6/11/16/18) vaccine in males 16 to 26 years old. Clin Vaccine Immunol. 2012;19(2):261-7.
39. Wheeler CM, Bautista OM, Tomassini JE, et al. Safety and immunogenicity of co-administered quadrivalent human papillomavirus (HPV)-6/11/16/18 L1 virus-like particle (VLP) and hepatitis B (HBV) vaccines. Vaccine. 2008;26(5):686-96.
40. Vesikari T, Van Damme P, Lindblad N, et al. An open-label, randomized, multicenter study of the safety, tolerability, and immunogenicity of quadrivalent human papillomavirus (types 6/11/16/18) vaccine given concomitantly with diphtheria, tetanus, pertussis, and poliomyelitis vaccine in healthy adolescents 11 to 17 years of age. Pediatr Infect Dis J. 2010;29(4):314-8.
41. Reisinger KS, Block SL, Collins-Ogle M, et al. Safety, tolerability, and immunogenicity of gardasil given concomitantly with Menactra and Adacel. Pediatrics. 2010;125(6):1142-51.
42. Arguedas A, Soley C, Loaiza C, et al. Safety and immunogenicity of one dose of MenACWY-CRM, an investigational quadrivalent meningococcal glycoconjugate vaccine, when administered to adolescents concomitantly or sequentially with Tdap and HPV vaccines. Vaccine. 2010;28(18):3171-9.
43. Noronha AS, Markowitz LE, Dunne EF. Systematic review of human papillomavirus vaccine coadministration. Vaccine. 2014. doi:10.1016/j.vaccine. 2013.12.037.
44. Malagon T, Drolet M, Boily M-C, et al. Cross-protective efficacy of two human papillomavirus vaccines: a systematic review and meta-analysis. Lancet Infect Dis. 2012;12(10):781-9.
45. Petras M, Sykora T, Andrys C, et al. Post-vaccination anti-human papillomavirus antibody seroprevalence among Czech teenaged girls and women. Int J Gynaecol Obstet. 2012;119(2):178-81.
46. Ruiz W, McClements WL, Jansen KU, et al. 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. 2005;3(1):2.
47. Mok CC, Ho LY, Fong LS, et al. Immunogenicity and safety of a quadrivalent human papillomavirus vaccine in patients with systemic lupus erythematosus: a case-control study. Ann Rheum Dis. 2013;72(5):659-64.
48. Jacobson DL, Bousvaros A, Ashworth L, et al. Immunogenicity and tolerability to human papillomavirus-like particle vaccine in girls and young women with inflammatory bowel disease. Inflamm Bowel Dis. 2013;19(7):1441-9.
49. Kahn JA, Xu J, Kapogiannis BG, et al. Immunogenicity and safety of the human papillomavirus 6, 11, 16, 18 vaccine in HIV-infected young women. Clin Infect Dis. 2013;57(5):735-44.
50. Wilkin T, Lee JY, Lensing SY, et al. Safety and immunogenicity of the quadrivalent human papillomavirus vaccine in HIV-1-infected men. J Infect Dis. 2010;202(8):1246-53.
51. Levin MJ, Moscicki AB, Song LY, et al. Safety and immunogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, and 18) vaccine in HIV-infected children 7 to 12 years old. J Acquir Immune Defic Syndr. 2010;55(2):197-204.
52. Yoshikawa H, Ebihara K, Tanaka Y, et al. Efficacy of quadrivalent human papillomavirus (types 6, 11, 16 and 18) vaccine (GARDASIL) in Japanese women aged 18-26 years. Cancer Sci. 2013;104(4):465-72.
53. Villa LL, Costa RL, Petta CA, et al. 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. Br J Cancer. 2006;95(11):1459-66. (Pubitemid 44863348)
54. Ali H, Donovan B, Wand H, et al. Genital warts in young Australians five years into national human papillomavirus vaccination programme: national surveillance data. BMJ. 2013;346:f2032.
55. Baandrup L, Blomberg M, Dehlendorff C, et al. Significant decrease in the incidence of genital warts in young Danish women after implementation of a national human papillomavirus vaccination program. Sex Transm Dis. 2013;40(2):130-5.
56. Baldur-Felskov B, Dehlendorff C, Munk C, et al. Early impact of human papillomavirus vaccination on cervical neoplasia: nationwide follow-up of young Danish women. J Natl Cancer Inst. 2014. doi:10.1093/jnci/djt460.
57. Bauer HM, Wright G, Chow J. Evidence of human papillomavirus vaccine effectiveness in reducing genital warts: an analysis of California public family planning administrative claims data, 2007-2010. Am J Public Health. 2012;102(5):833-5.
58. Blomberg M, Dehlendorff C, Munk C, et al. Strongly decreased risk of genital warts after vaccination against human papillomavirus: nationwide follow-up of vaccinated and unvaccinated girls in Denmark. Clin Infect Dis. 2013. doi:10.1093/cid/cit436.
59. Brotherton JM, Fridman M, May CL, et al. Early effect of the HPV vaccination programme on cervical abnormalities in Victoria, Australia: an ecological study. Lancet. 2011;377(9783):2085-92.
60. Crowe E, Pandeya N, Brotherton JM, et al. Effectiveness of quadrivalent human papillomavirus vaccine for the prevention of cervical abnormalities: case-control study nested within a population based screening programme in Australia. BMJ. 2014;348:g1458.
61. Delere Y, Remschmidt C, Leuschner J, et al. Human papillomavirus prevalence and probable first effects of vaccination in 20 to 25 year-old women in Germany: a population-based cross-sectional study via home-based self-sampling. BMC Infect Dis. 2014;14(1):87.
62. Flagg EW, Schwartz R, Weinstock H. Prevalence of anogenital warts among participants in private health plans in the United States, 2003-2010: potential impact of human papillomavirus vaccination. Am J Public Health. 2013;103(8):1428-35.
63. Gertig DM, Brotherton JM, Budd AC, et al. Impact of a population-based HPV vaccination program on cervical abnormalities: a data linkage study. BMC Med. 2013;11:227.
64. Korostil IA, Ali H, Guy RJ, et al. Near elimination of genital warts in Australia predicted with extension of human papillomavirus vaccination to males. Sex Transm Dis. 2013;40(11):833-5.
65. Leval A, Herweijer E, Ploner A, et al. Quadrivalent human papillomavirus vaccine effectiveness: a Swedish national cohort study. J Natl Cancer Inst. 2013;105(7):469-74.
66. Markowitz LE, Hariri S, Lin C, et al. Reduction in human papillomavirus (HPV) prevalence among young women following HPV vaccine introduction in the United States, National Health and Nutrition Examination Surveys, 2003-2010. J Infect Dis. 2013;208(3):385-93.
67. Mikolajczyk RT, Kraut AA, Horn J, et al. Changes in incidence of anogenital warts diagnoses after the introduction of human papillomavirus vaccination in Germany: an ecologic study. Sex Transm Dis. 2013;40(1):28-31.
68. Nsouli-Maktabi H, Ludwig SL, Yerubandi UD, et al. Incidence of genital warts among U.S. service members before and after the introduction of the quadrivalent human papillomavirus vaccine. MSMR. 2013;20(2):17-20.
69. Oliphant J, Perkins N. Impact of the human papillomavirus (HPV) vaccine on genital wart diagnoses at Auckland Sexual Health Services. N Z Med J. 2011;124(1339):51-8.
70. Luna J, Plata M, Gonzalez M, et al. Long-term follow-up observation of the safety, immunogenicity, and effectiveness of Gardasil in adult women. PLoS One. 2013;8(12):e83431.
71. Goldstone S. Long-term effectiveness of quadrivalent HPV vaccine against non-vaccine HPV types in men. The protocol 020 investigators (abstract no. OC 6-4). In: EUROGIN 2013: HPV at a crossroads - 30 years of research and practice, 3-6 November 2013, Florence.
72. Palefsky JM, Giuliano AR, Goldstone S, et al. HPV vaccine against anal HPV infection and anal intraepithelial neoplasia. N Engl J Med. 2011;365(17):1576-85.
73. Kjaer SK, Sigurdsson K, Iversen OE, et al. A pooled analysis of continued prophylactic efficacy of quadrivalent human papillomavirus (types 6/11/16/18) vaccine against high-grade cervical and external genital lesions. Cancer Prev Res (Phila). 2009;2(10):868-78.
74. Nygard M, Kruger Kjaer S, Dillner J, et al. Long-term effectiveness and immunogenicitity of Gardasil in the Nordic countries (abstract no. OC 6-3). In: EUROGIN 2013: HPV at a crossroads - 30 years of research and practice, 3-6 November 2013, Florence.
75. European Medicines Agency. CHMP variation assessment report: gardasil type II variation. 2010. http://www.ema.europa.eu/docs/en-GB/document-library/ EPAR---Assessment-Report---Variation/human/000703/WC500096580.pdf. Accessed 20 June 2013.
76. Joura EA, Leodolter S, Hernandez-Avila M, et al. 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. 2007;369(9574):1693-702. (Pubitemid 46783792)
77. The FUTURE II Study Group. Prophylactic efficacy of a quadrivalent human papillomavirus (HPV) vaccine in women with virological evidence of HPV infection. J Infect Dis. 2007;196(10):1438-46.
78. Olsson SE, Kjaer SK, Sigurdsson K, et al. Evaluation of quadrivalent HPV 6/11/16/18 vaccine efficacy against cervical and anogenital disease in subjects with serological evidence of prior vaccine type HPV infection. Hum Vaccin. 2009;5(10):696-704.
79. Joura EA, Garland SM, Paavonen J, et al. Effect of the human papillomavirus (HPV) quadrivalent vaccine in a subgroup of women with cervical and vulvar disease: retrospective pooled analysis of trial data. BMJ. 2012;344:e1401.
80. Kang WD, Choi HS, Kim SM. Is vaccination with quadrivalent HPV vaccine after loop electrosurgical excision procedure effective in preventing recurrence in patients with high-grade cervical intraepithelial neoplasia (CIN2-3)? Gynecol Oncol. 2013;130(2):264-8.
81. Barr E, Gause CK, Bautista OM, et al. Impact of a prophylactic quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle vaccine in a sexually active population of North American women. Am J Obstet Gynecol. 2008;198(3):261 e1-11.
82. Majewski S, Bosch FX, Dillner J, et al. The impact of a quadrivalent human papillomavirus (types 6, 11, 16, 18) virus-like particle vaccine in European women aged 16 to 24. J Eur Acad Dermatol Venereol. 2009;23(10):1147-55.
83. Perez G, Lazcano-Ponce E, Hernandez-Avila M, et al. Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like-particle vaccine in Latin American women. Int J Cancer. 2008;122(6):1311-8. (Pubitemid 351287231)
84. Clark LR, Myers ER, Huh W, et al. Clinical trial experience with prophylactic human papillomavirus 6/11/16/18 vaccine in young black women. J Adolesc Health. 2013;52(3):322-9.
85. 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. 2009;199(7):926-35.
86. Wheeler CM, 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 sexually active women aged 16-26 years. J Infect Dis. 2009;199(7):936-44.
87. Arnheim-Dahlstrom L, Pasternak B, Svanstrom H, et al. Autoimmune, neurological, and venous thromboembolic adverse events after immunisation of adolescent girls with quadrivalent human papillomavirus vaccine in Denmark and Sweden: cohort study. BMJ. 2013;347:f5906.
88. Borja-Hart NL, Benavides S, Christensen C. Human papillomavirus vaccine safety in pediatric patients: an evaluation of the vaccine adverse event reporting system. Ann Pharmacother. 2009;43(2):356-9.
89. Brotherton JM, Gold MS, Kemp AS, et al. Anaphylaxis following quadrivalent human papillomavirus vaccination. CMAJ. 2008;179(6):525-33.
90. Centers for Disease Control and Prevention. Human papillomavirus vaccination coverage among adolescent girls, 2007-2012, and postlicensure vaccine safety monitoring, 2006-2013: United States. MMWR Morb Mortal Wkly Rep. 2013;62(29):591-5.
91. Chao C, Klein NP, Velicer CM, et al. Surveillance of autoimmune conditions following routine use of quadrivalent human papillomavirus vaccine. J Intern Med. 2012;271:193-203.
92. Dana A, Buchanan KM, Goss MA, et al. Pregnancy outcomes from the pregnancy registry of a human papillomavirus type 6/11/16/18 vaccine. Obstet Gynecol. 2009;114(6):1170-8.
93. Gee J, Naleway A, Shui I, et al. Monitoring the safety of quadrivalent human papillomavirus vaccine: findings from the vaccine safety datalink. Vaccine. 2011;29(46):8279-84.
94. Grimaldi-Bensouda L, Guillemot D, Godeau B, et al. Autoimmune disorders and quadrivalent human papillomavirus vaccination of young female subjects. J Intern Med. 2013. doi:10.1111/joim.12155.
95. Klein NP, Hansen J, Chao C, et al. Safety of quadrivalent human papillomavirus vaccine administered routinely to females. Arch Pediatr Adolesc Med. 2012;166(12):1140-8.
96. Slade BA, Leidel L, Vellozzi C, et al. Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine. JAMA. 2009;302(7):750-7.
97. World Health Organization. Global advisory committee on vaccine safety, 12-13 June 2013: update on human papillomavirus vaccines. Wkly Epidemiol Rec. 2013;88(29):309-12.
98. Moreira ED Jr, Palefsky JM, Giuliano AR, et al. Safety and reactogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 viral-like-particle vaccine in older adolescents and young adults. Hum Vaccin. 2011;7(7):768-75.
99. Block SL, Brown DR, Chatterjee A, et al. Clinical trial and postlicensure safety profile of a prophylactic human papillomavirus (types 6, 11, 16, and 18) l1 virus-like particle vaccine. Pediatr Infect Dis J. 2010;29(2):95-101.
100. 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. 2009;114(6):1179-88.
101. Goss MA, Lievano F, Siminack M, et al. No adverse signals observed after exposure to human papillomavirus type 6/11/16/ 18 vaccine during pregnancy: 5 year pregnancy registry data (abstract no. SS 8-3). In: EUROGIN 2012: human papillomavirus, cervical and other human diseases, 8-11 July 2012, Prague.
102. Ojha RP, Jackson BE, Tota JE, et al. Guillain-Barre syndrome following quadrivalent human papillomavirus vaccination among vaccine-eligible individuals in the United States. Hum Vaccin Immunother. 2014;10(1):232-7.
103. Perricone C, Colafrancesco S, Mazor RD, et al. Autoimmune/ inflammatory syndrome induced by adjuvants (ASIA) 2013: unveiling the pathogenic, clinical and diagnostic aspects. J Autoimmun. 2013;47:1-16.
104. Colafrancesco S, Perricone C, Tomljenovic L, et al. Human papilloma virus vaccine and primary ovarian failure: another facet of the autoimmune/ inflammatory syndrome induced by adjuvants. Am J Reprod Immunol. 2013;70(4):309-16.
105. Lee SH. Detection of human papillomavirus (HPV) L1 gene DNA possibly bound to particulate aluminum adjuvant in the HPV vaccine Gardasil. J Inorg Biochem. 2012;117:85-92.
106. World Health Organization. Global advisory committee on vaccine safety: statement on the continued safety of HPV vaccination - 12 March. 2014. http://www.who.int/vaccine-safety/committee/topics/hpv/en/. Accessed 20 June 2014.
107. European Medicines Agency. European Medicines Agency replies to concerns of Sane Vax Inc. 2011. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news- and-events/news/2011/09/news-detail-001350.jsp&mid=WC0b01ac058004d5c1. Accessed 20 June 2014.
108. Harris T, Williams DM, Fediurek J, et al. Adverse events following immunization in Ontario's female school-based HPV program. Vaccine. 2014;32(9):1061-6.
109. Kang LW, Crawford N, Tang ML, et al. Hypersensitivity reactions to human papillomavirus vaccine in Australian schoolgirls: retrospective cohort study. BMJ. 2008;337:a2642.
110. World Health Organization. Global advisory committee on vaccine safety, 11-12 December 2013: human papillomavirus vaccines safety (HPV). Wkly Epidemiol Rec. 2014;89(7):58-60.
111. European Medicines Agency. PRAC recommendations on signals: adopted at the PRAC meeting of 7-10 April 2014. 2014. http://www.ema.europa.eu/docs/en-GB/ document-library/Other/2014/04/WC500165809.pdf Accessed 20 June 2014.
112. Siegrist CA, Lewis EM, Eskola J, et al. Human papilloma virus immunization in adolescent and young adults: a cohort study to illustrate what events might be mistaken for adverse reactions. Pediatr Infect Dis J. 2007;26(11):979-84. (Pubitemid 350287577)
113. Clothier HJ, Lee KJ, Sundararajan V, et al. Human papillomavirus vaccine in boys: background rates of potential adverse events. Med J Aust. 2013;198(10):554-8.
114. Annemans L, Remy V, Oyee J, et al. Cost-effectiveness evaluation of a quadrivalent human papillomavirus vaccine in Belgium. Pharmacoeconomics. 2009;27(3):231-45.
115. Bergeron C, Largeron N, McAllister R, et al. Cost-effectiveness analysis of the introduction of a quadrivalent human papillomavirus vaccine in France. Int J Technol Assess Health Care. 2008;24(1):10-9. (Pubitemid 351158538)
116. Brisson M, Laprise JF, Drolet M, et al. Comparative cost-effectiveness of the quadrivalent and bivalent human papillomavirus vaccines: a transmission-dynamic modeling study. Vaccine. 2013. doi:10.1016/j.vaccine.2013. 06.064.
117. Brisson M, Van de Velde N, De Wals P, et al. The potential cost-effectiveness of prophylactic human papillomavirus vaccines in Canada. Vaccine. 2007;25(29):5399-408. (Pubitemid 46977529)
118. Chesson HW, Ekwueme DU, Saraiya M, et al. Cost-effectiveness of human papillomavirus vaccination in the United States. Emerg Infect Dis. 2008;14(2):244-51. (Pubitemid 351213674)
119. Dasbach EJ, Insinga RP, Elbasha EH. The epidemiological and economic impact of a quadrivalent human papillomavirus vaccine (6/11/16/18) in the UK. BJOG. 2008;115(8):947-56. (Pubitemid 351841762)
120. Dasbach EJ, Largeron N, Elbasha EH. Assessment of the costeffectiveness of a quadrivalent HPV vaccine in Norway using a dynamic transmission model. Expert Rev Pharmacoecon Outcomes Res. 2008;8(5):491-500.
121. Dasbach EJ, Nagy L, Brandtmuller A, et al. The cost effectiveness of a quadrivalent human papillomavirus vaccine (6/11/ 16/18) in Hungary. J Med Econ. 2010;13(1):110-8.
122. Dee A, Howell F. A cost-utility analysis of adding a bivalent or quadrivalent HPV vaccine to the Irish cervical screening programme. Eur J Public Health. 2010;20(2):213-9.
123. Demarteau N, Tang CH, Chen HC. Cost-effectiveness analysis of the bivalent compared with the quadrivalent human papillomavirus vaccines in Taiwan. Value Health. 2012;15:622-31.
124. Kim JJ, Goldie SJ. Health and economic implications of HPV vaccination in the United States. N Engl J Med. 2008;359(8):821-32.
125. Kulasingam SL, Benard S, Barnabas RV, et al. Adding a quadrivalent human papillomavirus vaccine to the UK cervical cancer screening programme: a cost-effectiveness analysis. Cost Eff Resour Alloc. 2008. doi:10.1186/1478-7547- 6-4.
126. Mennini FS, Giorgi Rossi P, Palazzo F, et al. Health and economic impact associated with a quadrivalent HPV vaccine in Italy. Gynecol Oncol. 2009;112(2):370-6.
127. Szucs TD, Largeron N, Dedes KJ, et al. Cost-effectiveness analysis of adding a quadrivalent HPV vaccine to the cervical cancer screening programme in Switzerland. Curr Med Res Opin. 2008;24(5):1473-83. (Pubitemid 351741581)
128. Reynales-Shigematsu LM, Rodrigues ER, Lazcano-Ponce E. Cost-effectiveness analysis of a quadrivalent human papilloma virus vaccine in Mexico. Arch Med Res. 2009;40(6):503-13.
129. Favato G, Baio G, Capone A, et al. Novel health economic evaluation of a vaccination strategy to prevent HPV-related diseases: the BEST study. Med Care. 2012;50(12):1076-85.
130. Kim JJ. Targeted human papillomavirus vaccination of men who have sex with men in the USA: a cost-effectiveness modelling analysis. Lancet Infect Dis. 2010;10(12):845-52.
131. Chesson HW, Ekwueme DU, Saraiya M, et al. The cost-effectiveness of male HPV vaccination in the United States. Vaccine. 2011;29(46):8443-50.
132. Elbasha EH, Dasbach EJ. Impact of vaccinating boys and men against HPV in the United States. Vaccine. 2010;28(42):6858-67.
133. Elbasha EH, Dasbach EJ, Insinga RP. Model for assessing human papillomavirus vaccination strategies. Emerg Infect Dis. 2007;13(1):28-41. (Pubitemid 46057835)
134. Insinga RP, Dasbach EJ, Elbasha EH, et al. Cost-effectiveness of quadrivalent human papillomavirus (HPV) vaccination in Mexico: a transmission dynamic model-based evaluation. Vaccine. 2007;26(1):128-39. (Pubitemid 350218187)
135. Jit M, Choi YH, Edmunds WJ. Economic evaluation of human papillomavirus vaccination in the United Kingdom. BMJ. 2008;337:a769.
136. Kim JJ, Goldie SJ. Cost effectiveness analysis of including boys in a human papillomavirus vaccination programme in the United States. BMJ. 2009;339:b3884.
137. Olsen J, Jepsen MR. Human papillomavirus transmission and cost-effectiveness of introducing quadrivalent HPV vaccination in Denmark. Int J Technol Assess Health Care. 2010;26(2):183-91.
138. Zechmeister I, Blasio BF, Garnett G, et al. Cost-effectiveness analysis of human papillomavirus-vaccination programs to prevent cervical cancer in Austria. Vaccine. 2009;27(37):5133-41.
139. Taira AV, Neukermans CP, Sanders GD. Evaluating human papillomavirus vaccination programs. Emerg Infect Dis. 2004;10(11):1915-23. (Pubitemid 39458555)
140. Bresse X, Goergen C, Prager B, et al. Universal vaccination with the quadrivalent HPV vaccine in Austria: impact on virus circulation, public health and cost-effectiveness analysis. Expert Rev Pharmacoecon Outcomes Res. 2014;14(2):269-81.
141. Burger EA, Sy S, Nygard M, et al. Prevention of HPV-related cancers in Norway: cost-effectiveness of expanding the HPV vaccination program to include pre-adolescent boys. PLoS One. 2014. doi:10.1371/journal.pone.0089974.
142. Jit M, Chapman R, Hughes O. Comparing bivalent and quadrivalent human papillomavirus vaccines: economic evaluation based on transmission model. BMJ. 2011. doi:10.1136/bmj.d5775.
143. US FDA. Gardasil (human papillomavirus quadrivalent [types 6, 11, 16, and 18] vaccine recombinant): US prescribing information. 2014. http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094042. htm. Accessed 8 April 2014.
144. Bissett SL, Draper E, Myers RE, et al. Cross-neutralizing antibodies elicited by the Cervarix® human papillomavirus vaccine display a range of alpha-9 inter-type specificities. Vaccine. 2014;32(10):1139-46.
145. Bonanni P, Cohet C, Kjaer SK, et al. A summary of the postlicensure surveillance initiatives for GARDASIL/SILGARD. Vaccine. 2010;28(30):4719-30.
146. Canfell K, Chesson H, Kulasingam SL, et al. Modeling preventative strategies against human papillomavirus-related disease in developed countries. Vaccine. 2012;30(Suppl 5):F157-67.
147. World Health Organization. Human papillomavirus vaccines: WHO position paper. Wkly Epidemiol Rec. 2009;84(15):118-31.
148. European Centre for Disease Prevention and Control. Introduction of HPV vaccines in European Union countries: an update. 2012. http://www.ecdc.europa. eu/en/publications/Publications/20120905-GUI-HPV-vaccine-update.pdf. Accessed 20 June 2014.
149. Centers for Disease Control and Prevention. Quadrivalent human papillomavirus vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2007;56(RR-2):1-24.
150. European Cervical Cancer Association. HPV vaccination across Europe. 2009. http://www.ecca.info/fileadmin/user-upload/HPV-Vaccination/ECCA-HPV- Vaccination-April-2009.pdf. Accessed 20 June 2014.
151. European Centre for Disease Prevention and Control. Vaccine schedule. 2014. http://vaccine-schedule.ecdc.europa.eu/Pages/Scheduler.aspx. Accessed 20 June 2014.
152. Centers for Disease Control and Prevention. Recommendations on the use of quadrivalent human papillomavirus vaccine in males: Advisory Committee on Immunization Practices (ACIP), 2011. MMWR Morb Mortal Wkly Rep. 2011;60(50):1705-8.
153. Katz ML, Reiter PL, Heaner S, et al. Acceptance of the HPV vaccine among women, parents, community leaders, and healthcare providers in Ohio Appalachia. Vaccine. 2009;27(30):3945-52.
154. Barnack JL, Reddy DM, Swain C. Predictors of parents' willingness to vaccinate for human papillomavirus and physicians' intentions to recommend the vaccine. Womens Health Issues. 2010;20(1):28-34.
155. 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. 2011;11(1):39-44.
156. Moodley I, Tathiah N, Mubaiwa V, et al. High uptake of Gardasil vaccine among 9-12-year old schoolgirls participating in an HPV vaccination demonstration project in Kwazulu-Natal, South Africa. S Afr Med J. 2013;103(5):318-21.
157. Binagwaho A, Wagner CM, Gatera M, et al. Achieving high coverage in Rwanda's national human papillomavirus vaccination programme. Bull World Health Organ. 2012;90(8):623-8.
158. Singh Y, Shah A, Singh M, et al. Human papilloma virus vaccination in Nepal: an initial experience. Asian Pac J Cancer Prev. 2010;11(3):615-7.
159. Ladner J, Besson M-H, Hampshire R, et al. Assessment of eight HPV vaccination programs implemented in lowest income countries. BMC Public Health. 2012;12:370.
160. Centers for Disease Control and Prevention. National and state vaccination coverage among adolescents aged 13-17 years: United States, 2012. MMWR Morb Mortal Wkly Rep. 2013;62(34):685-93.
161. Hirth JM, Tan A, Wilkinson GS, et al. Completion rates of the human papillomavirus vaccine for insured females and males in the United States, 2006-2010 (abstract). In: 59th annual scientific meeting of the Society for Gynecologic Investigation, 21-24 March 2012, San Diego.
162. World Health Organization. Meeting of the strategic advisory group of experts on immunization, April 2014: conclusions and recommendations. Wkly Epidemiol Rec. 2014;89(21):221-36.
163. Centers for Disease Control and Prevention. CDC Wonder online VAERS database. 2013. http://wonder.cdc.gov/vaers.html. Accessed 8 April 2014.
164. Tomljenovic L, Shaw CA. Too fast or not too fast: the FDA's approval of Merck's HPV vaccine Gardasil. J Law Med Ethics. 2012;40(3):673-81.
165. HPV vaccine works against nine viral types. Cancer Discov. 2014;4(1):OF2.