Vaccination against HPV and view of new possibilities

Czech version

Authors: A. Mladěnka; J. Sláma
Authors‘ workplace: Gynekologicko-porodnická klinika VFN a 1. LF UK, Praha, přednosta prof. MUDr. A. Martan, DrSc ; Gynekologicko-porodnická klinika FN, Ostrava-Poruba, přednosta doc. MUDr. O. Šimetka, Ph. D., MBA
Published in: Ceska Gynekol 2018; 83(3): 218-225

Overview

Objective:

Overview of available information on current vaccination options against HPV and possibilities for further development.

Design:

Review article.

Settings:

Clinic of Gynecology and Obstetrics, University Hospital in Ostrava; Clinic of Gynecology and Obstetrics, General University Hospital in Prague.

Methods and results:

Three prophylactic vaccines have been developed against HPV infection and are all now avaliable in Czech Repulbic; nonavalent (Gardasil 9), quadrivalent vaccine (Silgard) and bivalent vaccine (Cervarix). Therapeutic vaccines, designed to induce regression of existing HPV-associated lesions, are in development and not yet clinically available.

Conclusion:

All three avaliable prophylactic vaccines show high efficacy in prevention of vaccine-specific HPV-type infection. The highest degree of protection is achieved in the population of HPV-naive women.

Keywords:

human papillomavirus, cervical cancer, HPV vaccination, bivalent HPV vaccine, quadrivalent HPV vaccine, nonavalent HPV vaccine

Sources

1. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med, 2007, 356, 19, p. 1915–1927.

2. Syncope after vaccination–-United States, January 2005–July 2007. MMWR Morb Mortal Wkly Rep, 2008, 57, 17, p. 457–460.

3. WHO vaccine-preventable diseases: monitoring system. 2015 global summary. 2014, World health organisation, URL: <http://apps.who.int/immunization_monitoring/globalsummary/coverages?c=CZE>.

4. Vaccine Schedule. 2016, European Centre for Disease Prevention and Control, URL: <http://vaccine-schedule.ecdc.europa.eu/Pages/Scheduler.aspx>.

5. C53 – Hrdlo děložní – cervicis uteri, ženy, srovnání incidence v ČR s ostatními zeměmi Evropy, přepočet na 100 000 osob. 2017, Ústav zdravotnických informací a statistiky ČR, URL: <http://www.svod.cz/graph/?sessid=hs4f0rfuklirjvnu08j46rqtv5&typ=zahranici_2008&diag=C53&incmor=inc&pohl=z&kraj=w&vek_od=0&vek_do=18&zobrazeni=table&incidence=1&mortalita=1&vypocet=c&obdobi_od=1977&obdobi_do=2013&stadium=&t=&n=&m=&pt=&pn=&pm=&t=&n=&zije=&umrti=&lecba=&ref=>.

6. C53 – ZN hrdla děložního – cervicis uteri, ženy, Časový vývoj, Počet případů na 100 000 osob. 2017, Ústav zdravotnických informací a statistiky ČR, URL: <http://www.svod.cz/graph/?sessid=ppnedc27vcpp664210c3b9nr64&typ=incmor&diag=C53&pohl=z&kraj=&vek_od=1&vek_do=18&zobrazeni=table&incidence=1&mortalita=1&mi=0&vypocet=c&obdobi_od=1977&obdobi_do=2015&stadium=&t=&n=&m=&pt=&pn=&pm=&t=&n=&zije=&umrti=&lecba=>.

7. Abramowitz, LP., Descamps, F., Denis, M., et al. Papillomavirus and cancers: should we extend vaccination to boys in France? J Public Health (Oxf), 2016.

8. Alvarez, RD., Huh, WK., Bae, S., et al. A pilot study of pNGVL4a-CRT/E7(detox) for the treatment of patients with HPV16+ cervical intraepithelial neoplasia 2/3 (CIN2/3). Gynecol Oncol, 2015.

9. Angelo, MG., Zima, J., Tavares Da Silva, F., et al. Post-licensure safety surveillance for human papillomavirus-16/18-AS04-adjuvanted vaccine: more than 4 years of experience. Pharmacoepidemiol Drug Saf, 2014, 23, 5, p. 456–465.

10. 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, p. f5906.

11. Bharti, B., Grewal, A., Kalia, R., Pathak, P. Vaccine related reactogenicity for primary immunization: a randomized controlled trial of 23(wider) vs. 25(narrower) gauge needles with same lengths. Indian J Pediatr, 2010, 77, 11, p. 1241–1246.

12. Bissett, SL., Godi, A., Jit, M., Beddows, S. Seropositivity to non-vaccine incorporated genotypes induced by the bivalent and quadrivalent HPV vaccines: A systematic review and meta-analysis. Vaccine, 2017, 35, 32, p. 3922–3929.

13. Bonanni, P., Ferro, A., Guerra, R., Iannazzo, S., et al. Vaccine coverage in Italy and assessment of the 2012–2014 National Immunization Prevention Plan. Epidemiol Prev, 2015, 39, 4, Suppl. 1, p. 146–158.

14. Brinth, L., Theibel, AC., Pors, K., Mehlsen, J. Suspected side effects to the quadrivalent human papilloma vaccine. Dan Med J, 2015, 62, 4.

15. Burger, EA., Sy, S., Nygard, M., Kristiansen, IS., 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, 9, 3, p. e89974.

16. Cabrnochová, H. 2015. Aktuality v očkování 2015. In Proceedings of the XI. Hradecké vakcinologické dny 2015, Hradec Králové, 01-OCT-2015 2015.

17. Cabrnochová, H. Očkování dětíi? – novinky 2017. In.: Zdravotnické noviny plus, 2017, vol. 2017.

18. Corbett, HJ., Fernando, GJ., Chen, X., et al. Skin vaccination against cervical cancer associated human papillomavirus with a novel micro-projection array in a mouse model. PLoS One, 2010, 5, 10, p. e13460.

19. Dion, GR., Teng, S., Boyd, LR., et al. Adjuvant human papillomavirus vaccination for secondary prevention: a systematic review. JAMA Otolaryngol Head Neck Surg, 2017, 143, 6, p. 614–622.

20. Dohme, MS. Souhrn údajů o přípravku Gardasil 9. In European Medicines Agency. 2015.

21. Duskova, J., Bekova, A., Dvorak, V., et al. [Results of the Czech National Cervical Cancer screening programme]. Klin Onkol, 2014, 27, Suppl. 2, p. 79–86.

22. 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, p. 705–719.

23. 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, p. 1343–1358.

24. Fait, T., Dvorak, V., Skrivanek, A., et al. [Epidemiology of genital warts in female population of Czech Republic]. Ces Gynek, 2012, 77, 4, s. 360–363.

25. Gambhira, R., Gravitt, PE., Bossis, I., et al. Vaccination of healthy volunteers with human papillomavirus type 16 L2E7E6 fusion protein induces serum antibody that neutralizes across papillomavirus species. Cancer Res, 2006, 66, 23, p. 11120–11124.

26. 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, p. 1179–1188.

27. 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, p. 1928–1943.

28. Gillison, ML., Broutian, T., Pickard, RK., et al. Prevalence of oral HPV infection in the United States, 2009–2010. JAMA, 2012, 307, 7, p. 693–703.

29. 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, p. 401–411.

30. Goncalves, AK., Cobucci, RN., Rodrigues, HM., et al. Safety, tolerability and side effects of human papillomavirus vaccines: a systematic quantitative review. Braz J Infect Dis, 2014, 18, 6, p. 651–659.

31. Grimaldi-Bensouda, L., Guillemot, D., Godeau, B., et al. Autoimmune disorders and quadrivalent human papillomavirus vaccination of young female subjects. J Intern Med, 2014, 275, 4, p. 398–408.

32. Group, FIS. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med, 2007, 356, 19, p. 1915–1927.

33. Guevara, A., Cabello, R., Woelber, L., et al. Antibody persistence and evidence of immune memory at 5years following administration of the 9-valent HPV vaccine. Vaccine, 2017, 35, 37, p. 5050–5057.

34. 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, p. 1247–1255.

35. Hebnes, JB., Olesen, TB., Duun-Henriksen, LK., et al. Prevalence of genital human papillomavirus among men in Europe: systematic review and meta-analysis. J Sex Med, 2014, 11, 11, p. 2630–2644.

36. Hildesheim, A., Herrero, R., Wacholder, S., et al. Effect of human papillomavirus 16/18 L1 viruslike particle vaccine among young women with preexisting infection: a randomized trial. JAMA, 2007, 298, 7, p. 743–753.

37. Jagu, S., Kwak, K., Garcea, RL., Roden, RB. Vaccination with multimeric L2 fusion protein and L1 VLP or capsomeres to broaden protection against HPV infection. Vaccine, 2010, 28, 28, p. 4478–4486.

38. Jagu, S., Kwak, K., Karanam, B., et al. Optimization of multimeric human papillomavirus L2 vaccines. PLoS One, 2013, 8, 1, p. e55538.

39. Jindra, C., Huber, B., Shafti-Keramat, S., et al. Attenuated recombinant influenza a virus expressing HPV16 E6 and E7 as a novel therapeutic vaccine approach. PLoS One, 2015, 10, 9, p. e0138722.

40. Joura, EA., Giuliano, AR., Iversen, OE., et al. A 9-valent HPV vaccine against infection and intraepithelial neoplasia in women. N Engl J Med, 2015, 372, 8, p. 711–723.

41. 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, p. 735–744.

42. 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, p. 264–268.

43. Kaufmann, AM., Nieland, JD., Jochmus, I., et al. Vaccination trial with HPV16 L1E7 chimeric virus-like particles in women suffering from high grade cervical intraepithelial neoplasia (CIN 2/3). Int J Cancer, 2007, 121, 12, p. 2794–2800.

44. Kenter, GG., Welters, MJ., Valentijn, AR., et al. Vaccination against HPV-16 oncoproteins for vulvar intraepithelial neoplasia. N Engl J Med, 2009, 361, 19, p. 1838–1847.

45. Kojic, EM., Kang, M., Cespedes, MS., et al. Immunogenicity and safety of the quadrivalent human papillomavirus vaccine in HIV-1-infected women. Clin Infect Dis, 2014, 59, 1, p. 127–135.

46. Kosalaraksa, P., Mehlsen, J., Vesikari, J., et al. An open-label, randomized study of a 9-valent human papillomavirus vaccine given concomitantly with diphtheria, tetanus, pertussis and poliomyelitis vaccines to healthy adolescents 11–15 years of age. Pediatr Infect Dis J, 2015, 34, 6, p. 627–634.

47. Largeron, N., Petry, KU., Jacob, J., et al. An estimate of the public health impact and cost-effectiveness of universal vaccination with a 9-valent HPV vaccine in Germany. Expert Rev Pharmacoecon Outcomes Res, 2017, 17, 1, p. 85–98.

48. Lee, HJ., Cho, H., Kim, MG., et al. Sublingual immunization of trivalent human papillomavirus DNA vaccine in baculovirus nanovector for protection against vaginal challenge. PLoS One, 2015, 10, 3, p. e0119408.

49. 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, p. 469–474.

50. Lin, K., Doolan, K., Hung, CF., WK., Wu, TC. Perspectives for preventive and therapeutic HPV vaccines. J Formos Med Assoc, 2010, 109, 1, p. 4–24.

51. Lin, K., Roosinovich, E., Ma, B., et al. Therapeutic HPV DNA vaccines. Immunol Res, 2010, 47, 1–3, p. 86–112.

52. Lin, SW., Ghosh, A., Porras, C., et al. HPV16 seropositivity and subsequent HPV16 infection risk in a naturally infected population: comparison of serological assays. PLoS One, 2013, 8, 1, p. e53067.

53. Ltd, M. S. D. Souhrn údajů o přípravku Silgard. In European Medicines Agency. Merck Sharp & Dohme Ltd, 2014.

54. McGrath, M., de Villiers, GK., Shephard, E., et al. Development of human papillomavirus chimaeric L1/L2 candidate vaccines. Arch Virol, 2013, 158, 10, p. 2079–2088.

55. 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, 1, p. 26–32.

56. Naud, PS., Roteli-Martins, CM., De Carvalho, NS., et al. Sustained efficacy, immunogenicity, and safety of the HPV-16/18 AS04-adjuvanted vaccine: final analysis of a long-term follow-up study up to 9.4 years post-vaccination. Hum Vaccin Immunother, 2014, 10, 8, p. 2147–2162.

57. Nygard, M., Saah, A., Munk, C., et al. Evaluation of the long-term anti-human papillomavirus 6 (HPV6), 11, 16, and 18 immune responses generated by the quadrivalent HPV vaccine. Clin Vaccine Immunol, 2015, 22, 8, p. 943–948.

58. 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, p. 301–314.

59. Panagiotou, OA., Befano, BL., Gonzalez, P., et al. Effect of bivalent human papillomavirus vaccination on pregnancy outcomes: long term observational follow-up in the Costa Rica HPV Vaccine Trial. BMJ, 2015, 351, p. h4358.

60. Peltecu, G., Bari, M., Lancu, G., Popa, F. Human papilloma virus and cervical preinvasive disease. J Med Life, 2009, 2, 4, p. 373–377.

61. Romanowski, B., de Borba, PC., Naud, PS., et al. Sustained efficacy and immunogenicity of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine: analysis of a randomised placebo-controlled trial up to 6.4 years. Lancet, 2009, 374, 9706, p. 1975–1985.

62. Rosales, R., Lopez-Contreras, M., Rosales, C., et al. Regression of human papillomavirus intraepithelial lesions is induced by MVA E2 therapeutic vaccine. Hum Gene Ther, 2014, 25, 12, p. 1035–1049.

63. S.a., GlaxoSmithKline Biologicals. Souhrn údajů o přípravku Cervarix. In European Medicines Agency. GlaxoSmithKline Biologicals s.a., 2015.

64. Safaeian, M., Porras, C., Schiffman, M., et al. Epidemiological study of anti-HPV16/18 seropositivity and subsequent risk of HPV16 and -18 infections. J Natl Cancer Inst, 2010, 102, 21, p. 1653–1662.

65. Sarid, R., Gao, SJ. Viruses and human cancer: from detection to causality. Cancer Lett, 2011, 305, 2, p. 218–227.

66. Sehnal, B., Neumannova, N., Driak, D., et al. [The 2-dose schedule of HPV vaccines in young adolescents]. Ces Gynek, 2015, 80, 1, s. 50–56.

67. Schellenbacher, C., Roden, R., Kirnbauer, R. Chimeric L1-L2 virus-like particles as potential broad-spectrum human papillomavirus vaccines. J Virol, 2009, 83, 19, p. 10085–10095.

68. Schellenbacher, C., Roden, RB., Kirnbauer, R. Developments in L2-based human papillomavirus (HPV) vaccines. Virus Res, 2017, 231, p. 166–175.

69. Schneider, A., Schwarz, TF., Hammerschmidt, T., Siebert, U. [Impact of vaccination against oncogenic human papillomavirus on the incidence and mortality of cervical cancer in Germany]. Med Klin (Munich), 2007, 102, 7, p. 515–523.

70. Slade, BA., Leidel, L., Vellozzi, C., et al. Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine. JAMA, 2009, 302, 7, p. 750–757.

71. Stanley, M. Potential mechanisms for HPV vaccine-induced long-term protection. Gynecol Oncol, 2010, 118, 1 Suppl., p. S2–7.

72. Stanley, M. HPV vaccination in boys and men. Hum Vaccin Immunother, 2014, 10, 7, p. 2109–2111.

73. Stevanovic, S., Draper, LM., Langhan, MM., et al. Complete regression of metastatic cervical cancer after treatment with human papillomavirus-targeted tumor-infiltrating T cells. J Clin Oncol, 2015, 33, 14, p. 1543–1550.

74. Trimble, CL., Morrow, MP., Kraynyak, KA., et al. Safety, efficacy, and immunogenicity of VGX-3100, a therapeutic synthetic DNA vaccine targeting human papillomavirus 16 and 18 E6 and E7 proteins for cervical intraepithelial neoplasia 2/3: a randomised, double-blind, placebo-controlled phase 2b trial. Lancet, 2015, 386, 10008, p. 2078–2088.

75. Tumban, E., Muttil, P., Escobar, CA., et al. Preclinical refinements of a broadly protective VLP-based HPV vaccine targeting the minor capsid protein, L2. Vaccine, 2015.

76. Tumban, E., Peabody, J., Peabody, DS., Chackerian, B. A universal virus-like particle-based vaccine for human papillomavirus: longevity of protection and role of endogenous and exogenous adjuvants. Vaccine, 2013, 31, 41, p. 4647–4654.

77. Tyler, M., Tumban, E., Chackerian, G. Second-generation prophylactic HPV vaccines: successes and challenges. Expert Rev Vaccines, 2014, 13, 2, p. 247–255.

78. Van Damme, P., Bonanni, P., Bosch, FX., et al. Use of the nonavalent HPV vaccine in individuals previously fully or partially vaccinated with bivalent or quadrivalent HPV vaccines. Vaccine, 2016, 34, 6, p. 757–761.

79. Van Damme, P., Meijer, CJ., Kieninger, D., et al. A phase III clinical study to compare the immunogenicity and safety of the 9-valent and quadrivalent HPV vaccines in men. Vaccine, 2016, 34, 35, p. 4205–4212.

80. Van Damme, P., Olsson, SE., Block, S., et al. Immunogenicity and safety of a 9-valent HPV vaccine. Pediatrics, 2015, 136, 1, p. e28–39.

81. Vesikari, T., Brodszki, N., Van Damme, P., et al. A randomized, double-blind, phase iii study of the immunogenicity and safety of a 9-valent human papillomavirus l1 virus-like particle vaccine (V503) versus Gardasil(R) in 9–15-year-old girls. Pediatr Infect Dis J, 2015, 34, 9, p. 992–998.

82. Villa, LL., Ault, KA., Giuliano, R., et al. Immunologic responses following administration of a vaccine targeting human papillomavirus types 6, 11, 16, and 18. Vaccine, 2006, 24, 27–28, p. 5571–5583.

83. Vintermyr, OK., Iversen, O., Thoresen, S., et al. Recurrent high-grade cervical lesion after primary conization is associated with persistent human papillomavirus infection in Norway. Gynecol Oncol, 2014, 133, 2, p. 159–166.

84. Yang, A., Farmer, E., Lin, J., et al. The current state of therapeutic and T cell-based vaccines against human papillomaviruses. Virus Res, 2017, 231, p. 148–165.

85. zur Hausen, H. Papillomaviruses and cancer: from basic studies to clinical application. Nat Rev Cancer, 2002, 2, 5, p. 342–350.