Prophylactic human papillomavirus vaccines: Potential for sea change

Expert Review of Vaccines

Volumn 6, Issue 4, 2007, Pages 511-525

  Ferenczy, Alex ^a   Franco, Eduardo L ^b  

^a MCGILL UNIVERSITY   (Canada)

^b MCGILL UNIVERSITY   (Canada)

Author keywords

Anogenital aerodigestive neoplasia; Cervical cancer screening; Cervical intraepithelial neoplasia; Efficacy; Human papillomavirus; Immune memory; Pharmacoeconomics; Prophylaxis; Psychosocial counseling; Respiratory papillomatosis

Indexed keywords

HEPATITIS B VACCINE; HERPES VACCINE; PLACEBO; SILGARD; UNCLASSIFIED DRUG; WART VIRUS VACCINE;

CANCER INCIDENCE; CARCINOGENESIS; CELLULAR IMMUNITY; CLINICAL TRIAL; CONDYLOMA; CONTROLLED CLINICAL TRIAL; COST EFFECTIVENESS ANALYSIS; DIGESTIVE SYSTEM CANCER; DRUG FORMULATION; FETOTOXICITY; GENITAL TRACT CANCER; HEADACHE; HIGH TEMPERATURE; HUMAN; HUMAN PAPILLOMAVIRUS TYPE 6; IMMUNOGENICITY; INJECTION SITE REACTION; PRIORITY JOURNAL; PROPHYLAXIS; RANDOMIZED CONTROLLED TRIAL; REVIEW; SEXUAL BEHAVIOR; SEXUALLY TRANSMITTED DISEASE; SIDE EFFECT; UTERINE CERVIX CANCER; VACCINATION; VERRUCA VULGARIS;

CERVICAL INTRAEPITHELIAL NEOPLASIA; CONDYLOMATA ACUMINATA; COST OF ILLNESS; FEMALE; HEALTH CARE COSTS; HUMANS; MALE; MASS IMMUNIZATION; PAPILLOMAVIRUS VACCINES; PRECANCEROUS CONDITIONS; RANDOMIZED CONTROLLED TRIALS; UTERINE CERVICAL NEOPLASMS; VACCINATION; VIRION;

EID: 34548032104     PISSN: 14760584     EISSN: 17448395     Source Type: Journal    
DOI: 10.1586/14760584.6.4.511     Document Type: Review

References (72)

1. deVilliers EM, Fauquet C, Broker TR, Bernard HU, zur Hausen H. Classification of papillomaviruses. Virology 324, 17-27 (2004). • Monumental work in classifying the members of the ever-growing human papillomavirus (HPV) family.
2. Will C, Schewe C, Petersen I. Incidence of HPV in primary and metastatic squamous cell carcinomas of the aerodigestive tract: implications for the establishment of clonal relationships. Histopathology 48, 605-606 (2006).
3. 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 366(9490), 991-998 (2005). • Describes the heterogeneous worldwide distribution of high oncogenic risk HPV types and comments on developing HPV screening tests and vaccines accordingly.
4. Weinstock H, Berman S, Cates W Jr. Sexually transmitted diseases among American youth: incidence and prevalence estimates. Perspect. Sex. Reprod. Health 36, 6-10 (2004).
5. Burchell AN, Richardson H, Mahmud SM et al. Modeling the sexual transmissibility of HPV infection using stochastic computer simulation and empirical data from a cohort study of young women in Montreal, Canada. Am. J. Epidemiol. 163(6), 534-543 (2006).
6. Frazer I, Cox T, Mayeaux EJ et al. Human papillomavirus infection. Pediatr. Infect. Dis. J. 25(1), S65-S81 (2006).
7. Spence AR, Franco EL, Ferenczy A. The role of human papillomaviruses in cancer. Am. J. Cancer 4, 49-64 (2005). •• Very thorough, complete review of the HPV-cancer connection and its clinical implications.
8. Kjaer SK, Munk C, Tran TN et al. The burden of genital warts: a study of nearly 70,000 women from four Nordic countries. Proceedings of the 6th International Multidisciplinary Congress of the European Research Organization on Genital Infection and Neoplasia. Paris, France, SS21-SS04 (2006).
9. Arduino JM, Roberts C, Skjeldestad FE et al. Cumulative incidence of genital warts by baseline HPV infection status in young, sexually active Norwegian women. Proceedings of the 6th International Multidisciplinary Congress of the European Research Organization on Genital Infection and Neoplasia. Paris, France, SS20-01 (2006).
10. Dziura B, Quinn S, Richard K. Performance of an imaging system vs. manual screening in the detection of squamous intraepithelial lesions of the uterine cervix. Acta Cytol. 50, 309-311 (2006).
11. Srodon M, Stoler MH, Baber GB, Kurman RJ. The distribution of low and high-risk HPV types in vulvar and vaginal intraepithelial neoplasia (VIN and VAIN). Am. J. Surg. Pathol. 30, 1513-1518 (2006).
12. Wiatrak BJ, Wiatrak DW, Broker TR, Lewis L. Recurrent respiratory papillomatosis: a longitudinal study comparing severity associated with human papilloma viral types 6 and 11 and other risk factors in a large pediatric population. Laryngoscope 114(Suppl. 104), 1-23 (2004). •• Outstanding, very thorough review of a potentially devastating condition in children.
13. Miller CS, Johnstone BM. Human papillomavirus as a risk factor for oral squamous cell carcinoma: a meta-analysis, 1982-1997. Oral Surg. Oral Med. Oral Pathol. Oral Radiol. Endod. 91(6), 622-635 (2001).
14. Parkin DM. The global health burden of infection-associated cancers in the year 2002. Int. J. Cancer 118, 3030-3044 (2006). • Major contribution to our knowledge regarding the burden of disease of infectious agents related to cancer worldwide.
15. Sankaranarayanan R, Ferlay J. Worldwide burden of gynaecological cancer: the size of the problem. Best Pract. Res. Clin. Obstet. Gynaecol. 20(2), 207-225 (2005).
16. Berry JM, Palefsky JM. A review of human papillomavirus vaccines: from basic science to clinical trials. Front. Biosci. 8, S333-S345 (2003). •• Excellent review of HPV infection in relation to recently published and ongoing clinical trials with prophylactic and therapeutic HPV vaccines.
17. Pascual A, Pariente M, Godinez JM et al. High prevalence of human papillomavirus 16 in penile carcinoma. Histol. Histopathol. 22, 177-183 (2007).
18. Kulasingam SL, Myers ER. Potential health and economic impact of adding a human papillomavirus vaccine to screening programs. J. Am. Med. Assoc. 290, 781-789 (2003). • Attractive mathematical analysis of epidemiologic data in estimating the potential economical benefits of mass HPV-vaccination programs.
19. Stanley M. Prophylactic HPV vaccines. J. Clin. Pathol. DOI:10.1136/jcp.2006.040568 (2007) (Epub ahead of print).
20. Brisson M, van de Velde N, Boily MC et al. The health and economic burden of HPV infection, genital warts, cervical dysplasia and cervical cancer in Canada. Presented at the 23rd International Papillomavirus Conference and Clinical Workshop, Prague, Czech Republic (2006).
21. Roden R, Wu TC. How will HPV vaccines affect cervical cancer? Nat. Rev. Cancer 6(10), 753-763 (2006). • Recent comprehensive review focusing on the implications of prophylactic HPV vaccines.
22. Franco EL, Harper DM. Vaccination against human papillomavirus infection: a new paradigm in cervical cancer control. Vaccine 23, 2388-2394 (2005). • Describes the implications of prophylactic HPV vaccination on the practice of cervical cancer screening in the 21st Century.
23. Insinga RP, Glass AG, Rush BB. The health care costs of cervical human papillomavirus-related disease. Am. J. Obstet. Gynecol. 191, 114-120 (2004).
24. Winer RL, Hughes JP, Qinghua F et al. Condom use and the risk of genital human papillomavirus infection in young women. N. Engl. J. Med. 354(25), 2645-2654 (2006). •• Probably the best designed clinical trial providing convincing evidence that condom use reduces the risk of HPV infection, not only in men but also in women.
25. Drain PK, Holmes KK, Hughes JP, Koutsky LA. Determinants of cervical cancer rates in developing countries. Int. J. Cancer 100(2), 199-205 (2002).
26. Koutsky LA, Ault KA, Wheeler CM et al. A controlled trial of a human papillomavirus type 16 vaccine. N. Engl. J. Med. 347(21), 1645-1651 (2002). • Describes the first groundbreaking, successful L1-virus-like particle vaccine randomized controlled trial against HPV-16 in young female adolescents.
27. Mao C, Koutsky LA, Ault KA et al. Efficacy of human papillomavirus-16 vaccine to prevent cervical intraepithelial neoplasia: a randomized controlled trial. Obstet. Gynecol. 107, 18-27 (2006).
28. 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 randomized controlled trial. Lancet 364(9447), 1757-1765 (2004). • Excellent article describing impressive data on tolerability, immunogenicity and efficacy of a bivalent HPV vaccine against persistent infection and residual disease in young women.
29. Harper DM, Franco EL, Wheeler CM et al, for the HPV Vaccine Study Group. 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 randomized control trial. Lancet 367, 1247-1255 (2006).
30. Villa LL, Costa RLR, Petta CA et al. Prophylactic, quadrivalent, human papillomavirus (types 6, 11, 16, 19) L1 virus-like particle vaccine in young women: a randomized, double-blind, placebo-controlled, multicentre, Phase II efficacy trial. Lancet Oncol. 6(5), 271-278 (2005). •• Landmark article reporting for the first time on the safety, immunogenicity and efficacy profile of a quadrivalent HPV vaccine against persistent infection and disease in young women - a must read.
31. Bryan FJ, Esser MT, Sings HL, Saah AJ, Barr E. 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 95(11), 1459-1466 (2006).
32. Paavonen J; FUTURE II Study Group. Efficacy of a quadrivalent HPV (types 6/11/16/18) L1 virus-like particle (VLP) vaccine against vaginal and vulvar precancerous lesions: a combined analysis. J. Clin. Oncol. 24(18S), 5011 (2006).
33. Siddiqui MAA, Perry CM. Human papillomavirus quadrivalent (types 6, 11, 16, 18) recombinant vaccine (Gardasil®). Drugs 66(9), 1263-1271 (2006). •• One of the best reviews on the latest, overall performance of Gardasil®- a must read.
34. Yu J, Lupinacci L, Railkar R et al. Immunologic responses following administration of a vaccine targeting human papillomavirus types 6, 11, 16 and 18. Vaccine 24, 5571-5583 (2006).
35. 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. Pediatr. Infect. Dis. 26, 201-209 (2007).
36. McMahon B, Bruden D, Petersen K et al. Antibody levels and protection after hepatitis B vaccination: results of a 15-year follow-up. Ann. Intern. Med. 142(5), 333-341 (2005).
37. Centers for Disease Control. Quadrivalent human papillomavirus vaccine. MMWR Recommendations and Reports 56/RR-2, March 23, (2007). • Review of data on Gardasil and detailed recommendations by the CDC for use in the USA.
38. Friedman LS, Kahn J, Middleman AB, Rosenthal SL, Zimet GD. Human papillomavirus (HPV) vaccine: a position statement of the Society for Adolescent Health. J. Adolescent Health 39, 620 (2006).
39. Centers for Disease Control. Youth risk behavior survey - United States 2003. MMWR 53(S S02), 1-96 (2004).
40. Expert Committee on Biological Standardization, World Health Organization. Guidelines to assure the quality, safety and efficacy of recombinant human papillomavirus virus-like particle vaccines. Geneva, Switzerland (2006).
41. Garnett PG. Role of herd immunity in determining the effect of vaccines against sexually transmitted disease. J. Infect. Dis. 191(Suppl. 1), S97-S106 (2005).
42. French KM, Barnabas RV, Lehtinen M et al. Strategies for the introduction of human papillomavirus vaccination: modeling the optimum age- and sex-specific pattern of vaccination in Finland. Br. J. Cancer 96, 514-518 (2007).
43. Bleeker MCG, Snijders PFJ, Voorhorst FJ, Meijer CJLM. Flat penile lesions: the infectious "invisible" link in the transmission of human papillomavirus. Int. J. Cancer 119, 2505-2512 (2006).
44. Schiller JT, Lowy DR. Prospects for cervical cancer prevention by human papillomavirus vaccination. Cancer Res. 66(21), 10229-10232 (2006).
45. Fraser C, Tomassini JE, Xi L et al. Modeling the long-term antibody response of a human papillomavirus (HPV) virus-like particle (VLP) type 16 prophylactic vaccine. Vaccine 25(21), 4324-4333 (2007).
46. Herrero R, Castle PE, Schiffman M et al. Epidemiologic profile of type-specific human papillomavirus infection and cervical neoplasia in Guanacaste, Costa Rica. J. Infect. Dis. 191(11), 1787-1789 (2005). • Provides interesting data about U-shaped, age-specific variations in HPV prevalence and infection, and the life-long probability of acquiring HPV infection.
47. 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 24, 5571-5583 (2006).
48. 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 24(33-34), 5937-5949 (2006).
49. Kahn J. Vaccination as a prevention strategy for human papillomavirus-related diseases. Adolescent Health 37, S10-S16 (2005).
50. Munoz N, Bosch FX, Castellsague X et al. Against which human papillomavirus types shall we vaccinate and screen? The international perspective. Int. J. Cancer 111(2), 278-285 (2004). •• Excellent paper describing the worldwide type-distribution of HPVs and relating the findings to vaccination and screening.
51. Mendez F, Munoz N, Posso H et al. Cervical co-infection with human papillomavirus (HPV) types and possible implications for the prevention of cervical cancer by HPV vaccines. J. Infect. Dis. 192, 1158-1165 (2005).
52. Davis K, Dickman ED, Ferris D, Dias JK. Human papillomavirus vaccine acceptability among parents of 10- to 15-year-old adolescents. J. Lower Genital Tract Dis. 8(3), 188-194 (2004). • Presents data on the importance of parental educational intervention for improved support for HPV vaccination of their 10-to 15-year-old adolescents.
53. Zimet GD, Perkins SM, Sturm LA, Bair RM, Juliar BE. Predictors of STI vaccine acceptability among parents and their adolescent children. J. Adolesc. Health 37(3), 179-186 (2005). • Cross-sectional study in which, curiously, both parents and adolescents expressed similar favorable responses to a survey without discussing the acceptability issue prior to participating in this study.
54. Olshen E, Woods ER, Austin SB, Luskin M, Bauchner H. Parental acceptance of the human papillomavirus vaccine. J. Adolesc. Health 37(3), 248-251 (2005). • Recent comprehensive review focusing on the implications of prophylactic HPV vaccines.
55. Stratton KR, Durch JS, Lawrence RS (Eds). Vaccines for the 21st Century: a tool for decision-making. Natl Acad. Press, DC, USA (2001).
56. Li M, Cripe TP, Estes PA, Lyon MK, Rose RC, Garcea RL. Expression of the human papillomavirus type 11 L1 capsid protein in Escherichia coli: characterization of protein domains involved in DNA binding and capsid assembly. J. Virol. Med. 71, 2988-2995 (1977).
57. Franco EL, Cuzick J, Hildesheim A, de Sanjose S. Issues in planning cervical cancer screening in the era of HPV vaccination. Vaccine 24(Suppl. 3), S171-S177 (2006).
58. Goldie SJ, Grima D, Kohli M, Wright TC, Weinstein M, Franco E. A comprehensive natural history model of HPV infection and cervical cancer to estimate the clinical impact of a prophylactic HPV-16/18 vaccine. Int. J. Cancer 106(6), 896-904 (2003).
59. Kohli M, Ferko N, Martin A et al. Estimating the long-term impact of a prophylactic human papillomavirus 16/18 vaccine on the burden of cervical cancer in the UK. Br. J. Cancer 96(1), 143-150 (2007).
60. Collins Y, Einstein MH, Gostout BS; Society of Gynecologic Oncologists Education Resource Panel writing group. Cervical cancer prevention in the era of prophylactic vaccines: a preview for gynaecologic oncologists. Gynecol. Oncol. 102, 552-562 (2006).
61. Saslow D, Runowicz CD, Solomon D et al. American Cancer Society guideline for the early detection of cervical neoplasia and cancer. CA Cancer J. Clin. 52, 342-362 (2002).
62. Davey E, Barrett A, Irwig L et al. Effect of study design and quality on unsatisfactory rates, cytology classifications and accuracy in liquid-based versus conventional cervical cytology: a systematic review. Lancet 367(9505), 122-132 (2006).
63. Wright TC Jr. HPV DNA testing for cervical cancer screening. Int. J. Gynecol. Obstet. 95(Suppl. 1), S239-S246 (2006).
64. American College of Obstetrics and Gynecology Committee on Adolescent Health Care. Evaluation and management of abnormal cervical cytology and histology in the adolescent. Obstet. Gynecol. 107(4), 963-968 (2006).
65. Moscicki AB, Schiffman M, Kjaer S, Villa LL. Chapter 5: updating the natural history of HPV and anogenital cancer. Vaccine 24(Suppl. 3), S42-S51 (2006).
66. Sadler L, Saftlas A, Wang W, Exeter M, Whittaker J, McCowan L. Treatment for cervical intraepithelial neoplasia and risk of preterm delivery. JAMA 291(17), 2100-2106 (2004).
67. Ferenczy A. Human papillomavirus infections: current concepts, new developments. J. SOGC 19, 369-381 (1997).
68. Cuzick J, Clavel C, Petry KU et al. Overview of the European and North American studies on HPV testing in primary cervical cancer screening. Int. J. Cancer 119(5), 1095-1101 (2006).
69. Khan MJ, Castle PE, Lorincz AT et al. The elevated 10-year risk of cervical precancer and cancer in women with human papillomavirus (HPV) type 16 or 18 and the possible utility of type-specific HPV testing in clinical practice. J. Natl Cancer Inst. 97, 1072-1079 (2005).
70. Castle PE, Solomon D, Schiffman M, Wheeler CM; ALTS Group. Human papillomavirus type 16 infections and 2-year absolute risk of cervical precancer in women with equivocal or mild cytologic abnormalities. J. Natl. Cancer Inst. 97, 1066-1071 (2005).
71. Munoz N, Bosch FX, de Sanjose S et al. Epidemiologic classification of human papillomavirus types associated with cervical cancer. N. Engl. J. Med. 348(6), 518-527 (2003).
72. FDA documentation of Gardasil® approval. Association of Reproductive Health Profession, press release. June 30, (2006). www.arhp.org/media/ pressreleases/99-157.cfm