The next generation of HPV vaccines: Nonavalent vaccine V503 on the horizon

Expert Review of Vaccines

Volumn 13, Issue 11, 2014, Pages 1279-1290

  Chatterjee, Archana ^a  

^a UNIVERSITY OF SOUTH DAKOTA   (United States)

Author keywords

efficacy; HPV; nonavalent; safety; vaccine

Indexed keywords

WART VIRUS VACCINE;

ARTICLE; CONDYLOMA ACUMINATUM; DRUG EFFICACY; GENOTYPE; HUMAN; HUMAN PAPILLOMAVIRUS TYPE 11; HUMAN PAPILLOMAVIRUS TYPE 16; HUMAN PAPILLOMAVIRUS TYPE 18; HUMAN PAPILLOMAVIRUS TYPE 31; HUMAN PAPILLOMAVIRUS TYPE 33; HUMAN PAPILLOMAVIRUS TYPE 45; HUMAN PAPILLOMAVIRUS TYPE 52; HUMAN PAPILLOMAVIRUS TYPE 58; IMMUNOGENICITY; PAPILLOMAVIRUS INFECTION; PERSISTENT INFECTION; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PRECANCER; PRIMARY PREVENTION; PROPHYLAXIS; SEXUALLY TRANSMITTED DISEASE; VACCINATION; DRUG APPROVAL; FOOD AND DRUG ADMINISTRATION; IMMUNOLOGY; PAPILLOMAVIRUS INFECTIONS; UNITED STATES;

DRUG APPROVAL; HUMANS; PAPILLOMAVIRUS INFECTIONS; PAPILLOMAVIRUS VACCINES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84911484186     PISSN: 14760584     EISSN: 17448395     Source Type: Journal    
DOI: 10.1586/14760584.2014.963561     Document Type: Article

References (106)

1. zur Hausen H. Human papillomaviruses and their possible role in squamous cell carcinomas. Curr Top Microbiol Immunol 1977;78:1-30
2. Forman D, de Martel C, Lacey CJ, et al. Global burden of human papillomavirus and related diseases. Vaccine 2012; 20(Suppl 5):F12-23
3. Jemal A, Bray F, Center MM, et al. Global cancer statistics. CA Cancer J Clin 2011; 61(2):69-90
4. WHO. International Agency for Research on Cancer. Globocan 2012: estimated cancer incidence, mortality and prevalence worldwide in 2012. Available from: http://globocan.iarc.fr/Pages/fact-sheets-cancer. aspx [Last Accessed 30 April 2014]
5. Walboomers JM, Jacobs MV, Manos MM, et al. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol 1999;189(1):12-19
6. Bosch FX, Lorincz A, Munoz N, et al. The causal relation between human papillomavirus and cervical cancer. J Clin Pathol 2002;55(4):244-65
7. Szarewski A. Cervarix-: a bivalent vaccine against HPV types 16 and 18, with cross-protection against other high-risk HPV types. Expert Rev Vaccines 2012;11(6): 645-57
8. Lowry DR, Schiller JT. Reducing HPV-associated cancer globally. Cancer Prev Res 2012;5(1):18-23
9. Bruni L, Diaz M, Castellsague X, et al. Cervical human papillomavirus prevalence in 5 continents: meta-analysis of 1 million women with normal cytological findings. J Infect Dis 2010;202:1789-99
10. Gustafsson L, Ponten J, Zack M, Adami HO. International incidence rates of invasive cervical cancer after introduction of cytological screening. Cancer Causes Control 1997;8:755-63
11. Centers for Disease Control and Prevention. U.S. Cancer Statistics. Available from: http://apps.nccd.cdc.gov/DCPC-INCA/DCPC-INCA.aspx [Last accessed 31 July 2014]
12. Arbyn M, Kyrgiou M, Simoens C, et al. Perinatal mortality and other severe adverse pregnancy outcomes associated with treatment of cervical intraepithelial neoplasia: meta-analysis. BMJ 2008;337: a1284
13. Szarewski A. Social and psychological aspects of cervical screening. Expert Rev Obstet Gynecol 2011;6(1):37-44
14. Bosch FX, Castellsagué X, de Sanjosé S. HPV and cervical cancer: screening or vaccination? Br J Cancer 2008;98(1):15-21
15. Bosch FX. Human papillomavirus: science and technologies for the elimination of cervical cancer. Expert Opin Pharmacother 2011;12(14):2189-204
16. Smith JS, Lindsay L, Hoots B, et al. Human papillomavirus type distribution in invasive cervical cancer and high-grade cervical lesions: a meta-analysis update. Int J Cancer 2007;121(3):621-32
17. 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):35-41
18. Giuliano AR, Tortolero-Luna G, Ferrer E, et al. Epidemiology of human papillomavirus infection in men, cancers other than cervical and benign conditions. Vaccine 2008;26(Suppl 10):K17-28
19. de Sanjose S, Quint WG, Alemany L, et al. Retrospective International Survey and HPV Time Trends Study Group. Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. Lancet Oncol 2010;11(11):1048-56
20. Koutsky L. Epidemiology of genital human papillomavirus infection. Am J Med 1997; 102(5A):3-8
21. Koshiol J, Lindsay L, Pimenta JM, et al. Persistent human papillomavirus infection and cervical neoplasia: a systematic review and meta-analysis. Am J Epidemiol 2008;168:123-37
22. Bhatia N, Lynde C, Vender R, Bourcier M. Understanding genital warts: epidemiology, pathogenesis, and burden of disease of human papillomavirus. J Cutan Med Surg 2013;17(Suppl 2):S47-54
23. Larson DA, Derkay CS. Epidemiology of recurrent respiratory papillomatosis. APMIS 2010;118(6-7):450-4
24. Insinga RP, Dasbach EJ, Myers ER. The health and economic burden of genital warts in a set of private health plans in the United States. Clin Infect Dis 2003;36: 1397-403
25. Dinh TH, Sternberg M, Dunne EF, Markowitz LE. Genital warts among 18-to 59-year-olds in the United States, national health and nutrition examination survey, 1999-2004. Sex Transm Dis 2008;35: 357-60
26. Syrjänen KJ. Annual disease burden due to human papillomavirus (HPV) 6 and 11 infections in Finland. Scand J Infect Dis Suppl 2009;107:3-32
27. Armstrong LR, Preston EJ, Reichert M, et al. Incidence and prevalence of recurrent respiratory papillomatosis among children in Atlanta and Seattle. Clin Infect Dis 2000;31:107-9
28. Hariri S, Dunne E, Saraiya M, et al. Human papillomavirus. In: Manual for the surveillance of vaccine-preventable diseases. 5th edition. 2011. p. 1-11
29. Schwarz TF, Kocken M, Petäjä T, et al. Correlation between levels of human papillomavirus (HPV)-16 and 18 antibodies in serum and cervicovaginal secretions in girls and women vaccinated with the HPV-16/18 AS04-adjuvanted vaccine. Hum Vaccin 2010;6(12):1054-61
30. 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 2009;374:301-14
31. 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 2009;2: 868-78
32. Dillner J, Kjaer SK, Wheeler CM, et al. on behalf of 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 2010;341:c3493
33. Guiliano AR, Palefsky JM, Goldstone S, et al. Efficacy of quadrivalent HPV vaccine against HPV infection and disease in males. N Engl J Med 2011;364:401-11
34. Palefsky J, Giuliano AR, Goldstone S, et al. HPV vaccine against anal HPV infection and anal intraepithelial neoplasia. N Engl J Med 2011;365:1576-85
35. Lehtinen M, Paavonen J, Wheeler CM, et al. Overall efficacy of HPV-16/18 AS04-adjuvanted vaccine against grade 3 or greater cervical intraepithelial neoplasia: 4-year end-of-study analysis of the randomised, double-blind PATRICIA trial. Lancet Oncol 2012;13:89-99
36. Markowitz LE, Dunne EF, Saraiya M, et al. Quadrivalent human papillomavirus vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep 2007;56:1-24
37. 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 Morb Mortal Wkly Rep 2010;59:626-9
38. Gardasil-Prescribing Information. Available from: www.merck.com/product/usa/pi-circulars/g/gardasil/gardasil-pi.pdf [Last accessed 3 April 2014]
39. Cervarix-Prescribing Information. Available from: www.gsksource.com/gskprm/htdocs/documents/CERVARIX-PIPIL. PDF [Last accessed 3 April 2014]
40. The FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med 2007;356: 1915-27
41. 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;369:1693-702
42. Hildesheim A, Herrero R, Wacholder S, et al. Effect of human papillomavirus 16/18 L1 virus like particle vaccine among young women with preexisting infection: a randomized trial. JAMA 2007;298:743-53
43. Dunne EF, Markowitz LE, Saraiya M, et al. CDC Grand Rounds: reducing the burden of HPV-associated cancer and disease. MMWR Morb Mortal Wkly Rep 2014; 63(4):1-7
44. Centers for Disease Control and Prevention (CDC). Quadrivalent human papillomavirus vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep 2007;56:RR-2
45. 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 Morb Mortal Wkly Rep 2010;59:626-9
46. Centers for Disease Control and Prevention (CDC). 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: 1705-8
47. Frazer IH. Development and implementation of papillomavirus prophylactic vaccines. J Immunol 2014;192: 4007-11
48. 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
49. 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;377:2085-92
50. Tabrizi S N, Brotherton JM, Kaldor JM, et al. Fall in human papillomavirus prevalence following a national vaccination program. J Infect Dis 2012;206:1645-51
51. Public Health England. National HPV vaccination coverage remains high and evidence shows programme effective in protecting women's health. Available from: www.gov.uk/government/news/national-hpvvaccination-coverage-remains-high-andevidence-shows-programme-effective-inprotecting-womens-health [Last accessed 26 August 2014]
52. Mesher D, Soldan K, Howell-Jones R, et al. Reduction in HPV 16/18 prevalence in sexually active young women following the introduction of HPV immunisation in England. Vaccine 2013;32:26-32
53. Niccolai LM, Julian PJ, Meek JI, et al. Declining rates of high-grade cervical lesions in young women in Connecticut, 2008-2011. Cancer Epidemiol Biomarkers Prev 2013;22:1446-50
54. Centers for Disease Control and Prevention (CDC). National and state vaccination coverage among adolescents aged 13-17 years-United States, 2011. MMWR Morb Mortal Wkly Rep 2012;61:671-7;
55. Erratum in: MMWR Morb Mortal Wkly Rep 2012;61:844
56. Centers for Disease Control and Prevention (CDC). Adult vaccination coverage-United States, 2010. MMWR Morb Mortal Wkly Rep 2012;61:66-72
57. Centers for Disease Control and Prevention (CDC). 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: 591-5
58. Eggertson L. Provinces weighing HPV vaccination of boys. CMAJ 2012;184: E250-1
59. President's Cancer Panel Annual Report. Increasing global HPV vaccination. Available from: http://deainfo.nci.nih.gov/advisory/pcp/annualReports/HPV/Part4. htm#sthash.YfDU450t.dpbs
60. Anonychuk AM, Bauch CT, Merid MF, et al. A cost-utility analysis of cervical cancer vaccination in preadolescent Canadian females. BMC Public Health 2009;9:401
61. Canfell K, Chesson H, Kulasingam SL, et al. Modeling preventative strategies against HPV-related disease in developed countries. Vaccine 2012;30:F157-67
62. Hopkins TG, Wood N. Female human papillomavirus (HPV) vaccination: global uptake and the impact of attitudes. Vaccine 2013;31:1673-9
63. Larson HJ, Brocard P, Garnett G. The India HPV-vaccine suspension. Lancet 2010;376:572-3
64. Editorial. GAVI injects new life into HPV vaccine rollout. Lancet 2013;381:1688
65. Sudenga SL, Royse KE, Shrestha S. Role and uptake of human papillomavirus vaccine in adolescent health in the United States. Adolesc Health Med Ther 2011;2: 63-74
66. Aruhuri B, Tarivonda L, Tenet V, et al. Prevalence of cervical human papillomavirus (HPV) infection in Vanuatu. Cancer Prev Res (Phila) 2012;5:746-53
67. McAdam M, Sakita J, Tarivonda L, et al. Evaluation of a cervical cancer screening program based on HPV testing and LLETZ excision in a low resource setting. PLoS ONE 2010;5:e13266
68. Tran NP, Hung CF, Roden R, Wu TC. Control of HPV infection and related cancer through vaccination. Recent Results Cancer Res 2014;193:149-71
69. Merck Newsroom. Merck's investigational 9-valent HPV Vaccine, V503, prevented 97 percent of cervical, vaginal and vulvar pre-cancers caused by five additional HPV types, in Phase III study. Available from: www.mercknewsroom.com/news-release/research-and-development-news/mercksinvestigational-9-valent-hpv-vaccine-v503-prevente [Last accessed 3 April 2014]
70. Zacks Equity Research. Published on February 25, 2014. Standard review for Merck's V503. Available from: www.zacks. com/stock/news/124331/Standard-Reviewfor-Mercks-V503 [Last accessed 3 April 2014]
71. Luxembourg A. on behalf of the V503 program team. An overview of the 9-valent HPV L1 virus-like particle vaccine clinical development program. abstract SS 8-3 Presented at EUROGIN; 3-6 November 2013; Florence, Italy
72. Luxembourg A. 9-valent HPV (9vHPV) Vaccine Program Key Results. ACIP Committee Meeting. February 27, 2014. Available from: www.cdc.gov/vaccines/acip/meetings/downloads/slides-2014-02/04-HPV-Luxembourg.pdf [Last accessed 12 September 2014]
73. Joura E. on behalf of the V503-001 study team. Efficacy and immunogenicity of a novel 9-valent HPV L1 virus-like particle vaccine in 16-to 26-year-old women. abstract SS 8-4 Presented at EUROGIN; 3-6 November 2013; Florence, Italy
74. Van Damme P. on behalf of the V503-002 study team. Safety and immunogenicity of a novel 9-valent HPV L1 virus-like particle vaccine in boys and girls 9-15 years old; comparison to women 16-26 years old. abstract SS 8-5 Presented at EUROGIN; 3-6 November 2013; Florence, Italy
75. Van Damme P, Vesikari T, Brodszki N, et al. Immunogenicity and safety of a novel 9-valent HPV L1 virus-like particle vaccine in girls 9-15 years of age compared to the quadrivalent vaccine. abstract SS 8-6 Presented at EUROGIN; 3-6 November 2013; Florence, Italy
76. Giuliano AR. on behalf of the V503-001 and V503-002 study teams. Safety and tolerability of a novel 9-valent HPV L1 virus-like particle vaccine in boys/girls age 9-15 and women age16-26. abstract SS 8-7 Presented at EUROGIN; 3-6 November 2013; Florence, Italy
77. TRENDS. Available from: www. trendsinurology.com/details/news/5631341/Nonavalent-HPV-vaccine-may-revive uptake.html [Last accessed 3 April 2014]
78. Centers for Disease Control and Prevention (CDC). Human papillomavirus vaccination coverage among adolescents, 2007-2013, and postlicensure vaccine safety monitoring, 2006-2014-United States. MMWR Morb Mortal Wkly Rep 2014;63(29):620-4
79. Van de Velde N, Boily M, Drolet M, et al. Population-level impact of the bivalent, quadrivalent, and nonavalent human papillomavirus vaccines: a model-based analysis. J Natl Cancer Inst 2012;104: 1712-23
80. Perez S, Lorenzo Y, Inãrrea A, et al. Expected impact of bivalent and nonavalent papillomavirus vaccine in cervical intraepithelial neoplasia grade 2 or worse in Galicia, Spain. abstract # P1822 Presented at 23rd European Congress of Clinical Microbiology and Infectious Diseases; 27-30 April 2013; Berlin, Germany
81. Franco EL, de Sanjose S, Broker TR, et al. Human papillomavirus and cancer prevention: gaps in knowledge and prospects for research, policy, and advocacy. Vaccine 2012;30(Suppl 5):F175-82
82. Porta M. The improbable plunge. What facts refute reasons to expect that the effectiveness of HPV vaccination programs to prevent cervical cancer could be low? Prev Med 2009;48:407-10
83. Wilyman J. HPV vaccination programs have not been shown to be cost-effective in countries with comprehensive Pap screening and surgery. Infect Agent Cancer 2013;8:21
84. Tota JE, Ramana-Kumar AV, El-Khatib Z, Franco EL. The road ahead for cervical cancer prevention and control. Curr Oncol 2014;21:e255-64
85. Zur Hausen H. HPV vaccines: what remains to be done? Expert Rev Vaccines 2011;10(11):1505-7
86. Drolet M, Laprise J, Boily M, et al. Potential cost-effectiveness of the nonavalent humanpapillomavirus (HPV) vaccine. Int J Cancer 2014;134:2264-8
87. Slade BA, Leidel L, Vellozzi C, et al. Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine. JAMA 2009;302: 750-7
88. Roteli-Martins CM, Naud P, De Borba P, et al. Sustained immunogenicity and efficacy of the HPV-16/18 AS04-adjuvanted vaccine: up to 8.4 years of follow-up. Hum Vaccin Immunother 2012;8:390-7
89. Tota JE, Ramanakumar AV, Jiang M, et al. Epidemiological approach to evaluate the potential for human papillomavirus type replacement post-vaccination. Am J Epidemiol 2013;178:625-34
90. Gersch ED, Gissmann L, Garcea RL. New approaches to prophylactic human papillomavirus vaccines for cervical cancer prevention. Antivir Ther 2012;17:425-34
91. Peres J. For cancers caused by HPV, two vaccines were just the beginning. J Natl Cancer Inst 2011;103:360-2
92. Bagarazzi ML, Yan J, Morrow MP, et al. Immunotherapy against HPV 16/18 generates potent TH1 and cytotoxic cellular immune responses. Sci Transl Med 2012;4:155ra38
93. Barrios K, Celis E. TriVax-HPV: an improved peptide-based therapeutic vaccination strategy against human papillomavirus-induced cancers. Cancer Immunol Immunother 2012;61:1307-17
94. CDC. HPV vaccine resources for healthcare professionals. Available from: www.cdc.gov/vaccines/who/teens/for-hcp/hpv-resources. html [Last accessed 30 April 2014]
95. U.S. National Institutes of Health. V503. Available from: http://clinicaltrials.gov/ct2/results?term=V503 [Last accessed 30 April 2014]
96. A Study of V503 Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASILTM (V503-006). Available from: http://clinicaltrials.gov/show/NCT01047345
97. A Study of V503 Given Concomitantly With MenactraTM and AdacelTM in 11 to 15 Year Olds (V503-005)(COMPLETED). http://ClinicalTrials.gov/show/NCT00988884
98. A Study of V503 Vaccine Given Concomitantly With REPEVAXTM in 11 to 15 Year Olds (V503-007 AM1). http://ClinicalTrials.gov/show/NCT01073293
99. A Study of V503 in Preadolescents and Adolescents (V503-002). http://ClinicalTrials.gov/show/NCT00943722
100. Multivalent HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year Old Men and Women (V503-003). http://ClinicalTrials.gov/show/NCT01651949
101. Multivalent HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year Old Men and Women (V503-003). http://ClinicalTrials.gov/show/NCT01984697
102. A Study of the Safety, Tolerability, and Immunogenicity of V503 Administered to 9-to 15-Year-Old Japanese Girls (V503-008). http://ClinicalTrials.gov/show/NCT01254643
103. Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001). http://ClinicalTrials.gov/show/NCT00543543
104. A Study to Compare Immune Response of V503 to Gardasil in 16-to 26-year-old Men. http://ClinicalTrials.gov/show/NCT02114385
105. Immunogenicity and Tolerability of V503 Versus GARDASIL. http://ClinicalTrials.gov/show/NCT01304498
106. An update on HPV vaccination in the United States. Available from: www.uab. edu/medicine/obgynresidency/images/Progress/Syllabi/CombMD/TH%20MD% 202%20Huh.pdf