HPV vaccine: Cervarix

Expert Opinion on Biological Therapy

Volumn 10, Issue 3, 2010, Pages 477-487

  Szarewski, Anne ^a  

^a QUEEN MARY UNIVERSITY OF LONDON   (United Kingdom)

Author keywords

Cervarix; Cervical cancer; HPV vaccine; Human papillomavirus

Indexed keywords

3 O DESACYL 4' MONOPHOSPHORYL LIPID A ALUMINUM HYDROXIDE SALT; CAPSID PROTEIN L1; IMMUNOGLOBULIN G ANTIBODY; IMMUNOLOGICAL ADJUVANT; UNCLASSIFIED DRUG; VIRUS DNA; WART VIRUS VACCINE;

ADENOCARCINOMA; ANTIBODY BLOOD LEVEL; ANTIBODY RESPONSE; ANTIBODY TITER; CANCER IMMUNIZATION; CANCER PREVENTION; CELLULAR IMMUNITY; CLINICAL TRIAL; DNA TUMOR VIRUS; DRUG DOSAGE FORM COMPARISON; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FETUS DISEASE; GROUPS BY AGE; HUMAN; 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; HUMAN PAPILLOMAVIRUS TYPE 59; IMMUNOGENICITY; IMMUNOREACTIVITY; INFECTION PREVENTION; INJECTION SITE PAIN; INJECTION SITE REACTION; INJECTION SITE SWELLING; MEMORY CELL; PREPUBERTY; REVIEW; SEXUAL BEHAVIOR; SPONTANEOUS ABORTION; STRAIN DIFFERENCE; TREATMENT RESPONSE; UTERINE CERVIX CANCER; UTERINE CERVIX CARCINOMA IN SITU; VIRUS INFECTION; VIRUS LIKE AGENT;

ALPHAPAPILLOMAVIRUS; ANTIBODIES, VIRAL; FEMALE; HUMANS; PAPILLOMAVIRUS VACCINES; UTERINE CERVICAL NEOPLASMS;

HUMAN PAPILLOMAVIRUS; HUMAN PAPILLOMAVIRUS TYPE 16;

EID: 76949103306     PISSN: 14712598     EISSN: None     Source Type: Journal    
DOI: 10.1517/14712591003601944     Document Type: Review

References (79)

1. Ferlay J, Bray P, Pizani P, Parkin DM. Cancer incidence, mortality and prevalence worldwide. IARC Press, Lyon, France; 2004
2. Peto J, Gilham C, Fletcher O, Matthews FE. The cervical cancer epidemic that screening has prevented in the UK. Lancet 2004;364(9430):249-256
3. 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
4. French DP, Maissi E, Marteau TM. Psychological costs of inadequate cervical smear test results. Br J Cancer 2004;91(11):1887-1892
5. Cohen J. Public health. High hopes and dilemmas for a cervical cancer vaccine. Science 2005;308(5722):618-621
6. Lerman C, Miller SM, Scarborough R, et al. Adverse psychologic consequences of positive cytologic cervical screening. Am J Obstet Gynecol 1991;165(3):658-662
7. Wolstenholme JL, Whynes DK. Stage-specific treatment costs for cervical cancer in the United Kingdom. Eur J Cancer 1998;34(12):1889-1893
8. Jacob M, Broekhuizen FF, Castro W, Sellors J. Experience using cryotherapy for treatment of cervical precancerous lesions in low-resource settings. Int J Gynaecol Obstet 2005;89(Suppl 2):S13-20
9. 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
10. Collins Y, Einstein MH, Gostout BS, et al. Cervical cancer prevention in the era of prophylactic vaccines: a preview for gynecologic oncologists. Gynecol Oncol 2006;102(3):552-562
11. Parkin DM, Bray F. Chapter 2: The burden of HPV-related cancers. Vaccine 2006;24(Suppl 3):S11-25
12. 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
13. Koutsky L. Epidemiology of genital human papillomavirus infection. Am J Med 1997;102(5A):3-8
14. 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
15. Brown RE, Breugelmans JG, Theodoratou D, Benard S. Costs of detection and treatment of cervical cancer, cervical dysplasia and genital warts in the UK. Curr Med Res Opin 2006;22(4):663-670
16. Stanley M. Immune responses to human papillomavirus. Vaccine 2006;24(Suppl 1):S16-22
17. Schwarz TF, Leo O. Immune response to human papillomavirus after prophylactic vaccination with AS04-adjuvanted HPV-16/18 vaccine: improving upon nature. Gynecol Oncol 2008;110(3 Suppl 1):S1-10
18. Viscidi RP, Schiffman M, Hildesheim A, et al. Seroreactivity to human papillomavirus (HPV) types 16, 18, or 31 and risk of subsequent hpv infection: results from a population-based study in Costa Rica. Cancer Epidemiol Biomarkers Prev 2004;13(2):324-327
19. Harper DM, Franco EL, Wheeler C, et al. Efficacy of a bivalent L1 virus-like particle vaccine in prevention of infection with human papillomavirus types 16 and 18 in young women: a randomised controlled trial. Lancet 2004;364(9447):1757-1765
20. 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):271-278
21. Boland G, Beran J, Lievens M, et al. Safety and immunogenicity profile of an experimental hepatitis B vaccine adjuvanted with AS04. Vaccine 2004;23(3):316-320
22. Pedersen C, Petaja T, Strauss G, et al. Immunization of early adolescent females with human papillomavirus type 16 and 18 L1 virus-like particle vaccine containing AS04 adjuvant. J Adolesc Health 2007;40(6):564-571
23. Harper DM, Franco EL, Wheeler CM, et al. 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 2006;367(9518):1247-1255
24. Paavonen J, Jenkins D, Bosch FX, et al. 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 (Patricia trial). Lancet 2007;369(9580):2161-2170
25. 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(9686):301-314
26. 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):1459-1466
27. 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 2007;369(9576):1861-1868
28. 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):1693-1702
29. Koutsky L. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med 2007;356:1915-1927
30. Einstein MH, Schiller JT, Viscidi RP, et al. Clinician's guide to human papillomavirus immunology: knowns and unknowns. Lancet Infect Dis 2009;9(6):347-356
31. Schwarz TF SM, Schneider A, Wysocki J, et al; HPV Study Group for Adult Women. Immunogenicity and tolerability of an HPV-16/18 AS04-adjuvanted prophylactic cervical cancer vaccine in women aged 15-55 years. Vaccine 2009;27(4):581-587
32. Romanowski B. Sustained efficacy and immunogenicity of the human papillomavirus (HPV) - 16/18 ASO4-adjuvanted vaccine: analysis of a randomised placebo-controlled trial up to 6.4 years. Lancet 2009;374:1975-1985
33. De Carvalho NS, Roteli-Martins CM, Teixeira J, et al. Immunogenicity and safety of HPV 16/18 AS04 adjuvanted vaccine up to 7.3 years. 25th International Papillomavirus Conference; Malmo, Sweden; 2009
34. Giannini SL, Hanon E, Moris P, et al. Enhanced humoral and memory B cellular immunity using HPV16/18 L1 VLP vaccine formulated with the MPL/ aluminium salt combination (AS04) compared to aluminium salt only. Vaccine 2006;24(33-34):5937-5949
35. Einstein MH, Baron M, Levin MJ, et al. Comparison of the immunogenicity and safety of cervarix() and gardasil((R)) human papillomavirus (HPV) cervical cancer vaccines in healthy women aged 18 - 45 years. Hum Vaccin 2009;5(10):705-719
36. David MP, 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 2009 [Epub ahead of print]; doi:10.1016/ j.ygyno.2009.01.011)
37. Schiller JT, Lowy DR. Immunogenicity testing in human papillomavirus virus-like-particle vaccine trials. J Infect Dis 2009;200(2):166-171
38. 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. Gynecol Oncol 2008;110(3 Suppl 1):S18-25
39. 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(2):123-137
40. Skinner R, Apter D, Chow S, et al. Cross protective efficacy of Cervarix- against oncogenic HPV types beyond HPV-16/18. 25th International Papillomavirus Conference; Malmo, Sweden; 2009
41. 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):926-935
42. Gardasil. Summary of product characteristics, UK. Available from: http://emc.medicines.org.uk/document. aspx?documentId=19016 (last updated 25 September 2009)
43. 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):936-944
44. Smith HO, Tiffany MF, Qualls CR, Key CR. The rising incidence of adenocarcinoma relative to squamous cell carcinoma of the uterine cervix in the United States-a 24-year population-based study. Gynecol Oncol 2000;78(2):97-105
45. Bosch FX, Burchell AN, Schiffman M, et al. Epidemiology and natural history of human papillomavirus infections and type-specific implications in cervical neoplasia. Vaccine 2008;26(Suppl 10):K1-16
46. Einstein M, Baron M, Levin M, et al.; on behalf of the HPV-010 Study Group. Comparative evaluation of immunogenicity of two prophylactic human papillomavirus cervical cancer vaccines. 16th International meeting of the European Society of Gynaecological Oncology (ESGO); 11-14 October 2009; Belgrade, Serbia
47. Pichichero M. Booster vaccinations: can immunologic memory outpace disease pathogenesis? Pediatrics 2009;124(6);1633-41
48. Einstein MH. Acquired immune response to oncogenic human papillomavirus associated with prophylactic cervical cancer vaccines. Cancer Immunol Immunother 2008;57(4):443-451
49. Schiller JT, Castellsague X, Villa LL, Hildesheim A. An update of prophylactic human papillomavirus L1 virus-like particle vaccine clinical trial results. Vaccine 2008;26(Suppl 10):K53-61
50. 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. Hum Vaccin 2009;5(5):332-340
51. Verstraeten T, Descamps D, David MP, et al. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine 2008;26(51):6630-6638
52. Siddiqui MA, Perry CM. Human papillomavirus quadrivalent (types 6, 11, 16, 18) recombinant vaccine (gardasil). Drugs 2006;66(9):1263-71; discussion 72-73
53. 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):1949-1957
54. Franco EL, Villa LL, Sobrinho JP, et al. Epidemiology of acquisition and clearance of cervical human papillomavirus infection in women from a high-risk area for cervical cancer. J Infect Dis 1999;180(5):1415-1423
55. Munoz N, Mendez F, Posso H, et al. Incidence, duration, and determinants of cervical human papillomavirus infection in a cohort of Colombian women with normal cytological results. J Infect Dis 2004;190(12):2077-2087
56. Coupe VM, Berkhof J, Bulkmans NW, et al. 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
57. Sellors JW, Karwalajtys TL, Kaczorowski J, et al. Incidence, clearance and predictors of human papillomavirus infection in women. CMAJ 2003;168(4):421-425
58. Grainge MJ, Seth R, Guo L, et al. Cervical human papillomavirus screening among older women. Emerg Infect Dis 2005;11(11):1680-1685
59. Clifford GM, Gallus S, Herrero R, et al. Worldwide distribution of human papillomavirus types in cytologically normal women in the International Agency for Research on Cancer HPV prevalence surveys: a pooled analysis. Lancet 2005;366(9490):991-998
60. Castellsagué X SA, Kaufmann AM, Bosch FX. HPV vaccination against cervical cancer in women above 25 years of age: key considerations and current perspectives. Gynecol Oncol 2009;115:S15-23
61. Cuschieri KS, Horne AW, Szarewski A, Cubie HA. Public awareness of human papillomavirus. J Med Screen 2006;13(4):201-207
62. Miura S, Matsumoto K, Oki A, et al. Do we need a different strategy for HPV screening and vaccination in East Asia? Int J Cancer 2006;119(11):2713-2715
63. Denny L, Boa R, Williamson AL, et al. Human papillomavirus infection and cervical disease in human immunodeficiency virus-1-infected women. Obstet Gynecol 2008;111(6):1380-1387
64. Moscicki AB, Weinberg A, Song L-Y, et al. Safety and immunogenicity of gardasil in HIV-infected children. 25th International Papillomavirus Conference; Malmo, Sweden; 2009
65. Eggertson L. Three provinces to study 2-dose HPV vaccine. CMAJ 2007;177(5):444-445
66. Dobson S, Dawar M, Scheifele D, et al. Are 2 doses of HPV vaccine adequate in girls? 25th International Papillomavirus Conference; Malmo, Sweden; 2009
67. Kane MA. Human papillomaviruses (HPV) vaccines: implementation and communication issues. J Fam Plann Reprod Health Care 2008;34(1):3-4
68. Michels KB, Hausen HZ. HPV vaccine for all. Lancet 2009;374(9686):268-270
69. Szarewski A. HPV vaccines: peering through the fog. J Fam Plann Reprod Health Care 2008;34(4):207-209
70. Hughes JP, Garnett GP, Koutsky L. The theoretical population-level impact of a prophylactic human papilloma virus vaccine. Epidemiology 2002;13(6):631-639
71. Garnett GP. Role of herd immunity in determining the effect of vaccines against sexually transmitted disease. J Infect Dis 2005;191(Suppl 1):S97-106
72. Bottiger M, Forsgren M. Twenty years' experience of rubella vaccination in Sweden: 10 years of selective vaccination (of 12-year-old girls and of women postpartum) and 13 years of a general two-dose vaccination. Vaccine 1997;15(14):1538-1544
73. Kim J. Mathematical model of HPV provides insight into impacts of risk factors and vaccine. PLoS Med 2006;3(5):e164
74. Martin F, Bower M. Anal intraepithelial neoplasia in HIV positive people. Sex Transm Infect 2001;77(5):327-331
75. Giuliano A, Palefsky J. Quadrivalent HPV vaccine efficacy against male genital disease and infection. 25th International Papillomavirus Conference; Malmo, Sweden; 2009
76. Szarewski A. Raising awareness of human papillomavirus and cervical cancer prevention: the need for clinical education (in press). Future Virol 2009;4(5):431-436
77. Le Tallec D, Doucet D, Elouahabi A, et al. Cervarix, the GSK HPV-16/HPV-18 AS04-adjuvanted cervical cancer vaccine, demonstrates stability upon long-term storage and under simulated cold chain break conditions. Hum Vaccin 2009;5(7):467-474
78. Schiller J, Nardelli-Haefliger D. Second generation HPV vaccines to prevent cervical cancer. Vaccine 2006;24(S3):147-153
79. Bosch FX CX, de Sanjose S. HPV and cervical cancer: screening or vaccination? Br J Cancer 2008;98:15-21