The 2-dose schedule of HPV vaccines in young adolescents

Česká verzia

Authors: B. Sehnal ¹; N. Neumannová ¹; D. Driák ¹ ; M. Halaška ¹; M. Kotoulová ¹; J. Sláma ²
Authors place of work: Gynekologicko-porodnická klinika 1. LF UK a Nemocnice Na Bulovce, Praha, přednosta prof. MUDr. M. Halaška, DrSc. ¹; Onkogynekologické centrum, Gynekologicko-porodnická klinika 1. LF UK a VFN, Praha, přednosta prof. MUDr. A. Martan, DrSc. ²
Published in the journal: Ceska Gynekol 2015; 80(1): 50-56

Summary

Objective:
To summarize new knowledge about the 2-dose HPV vaccine schedule in young adolescents.

Design:
Review article.

Setting:
Department of Gynaecology and Obstetrics, First Faculty of Medicine, Charles University and Hospital Na Bulovce in Prague; Oncogynaecological Center, First Faculty of Medicine, Charles University and General University Hospital in Prague.

Results:
The goal of immunization programs in many countries is the prevention of cervical cancer using either the bivalent or the quadrivalent HPV vaccine. The vaccines, which were designed to prevent cervical cancer outcomes in adults, need to be administered before the onset of sexual activity. Since the HPV vaccines are among the most expensive of all the widely recommended vaccines, limited financial resources restrain the HPV vaccination in some countries around the word. Higher immunogenicity of both HPV vaccines in young adolescents, as well as potential cost savings, have prompted discussions about the efficacy of the 2-dose HPV vaccine schedule. Results of the immunobridging studies showed that two doses of the bivalent and the quadrivalent HPV vaccine in young girls induced geometric mean antibody titers that were non-inferior to geometric mean antibody titers elicited in older girls and women with three doses of the same vaccine. Non-inferiority for HPV-16, -18, -31 and -45 was obtained for the 2-dose of the bivalent HPV vaccine in girls 9–14 years old in the period of 48 months and for HPV-6, -11, -16 and -18 for the 2-dose of the quadrivalent HPV vaccine in girls 9–13 years old in the period of 36 months.

Conclusion:
These results indicate that the bivalent and the quadrivalent vaccine HPV vaccine applied in 2 doses has sufficient immunogenity in young girls.

Keywords:
human papillomavirus, cervical cancer, 2-dose schedule of HPV vaccination, bivalent HPV vaccine, quadrivalent HPV vaccine

Zdroje

1. Beran, J. Význam adjuvantního systému AS04 ve vakcíně proti lidskému papilomaviru. Vakcinologie, 2013, 7, s. 64–71.

2. Bouvard, V., Baan, R., Straif, K., et al. A review of human carcinogens – Part B: biological agents. Lancet Oncol, 2009, 10(4), p. 321–322.

3. Carter, JJ., Koutsky, LA., Hughes, JP., et al. Comparison of human papillomavirus types 16, 18, and 6 capsid antibody responses following incident infection. J Inf Diseas, 2000, 181(6), p. 1911–1919.

4. Cassidy, WM., Watson, B., Ioli, VA., et al. A randomized trial of alternative two and three-dose hepatitis B vaccination regimens in adolescents: antibody responses, safety and immunologic memory. Pediatrics, 2001, 107, p. 626–631.

5. Cervarix SPC (Summary of Product Characteristics, Souhn údajů o přípravku). Available from: http://www.medicines.org.uk/emc/medicine/20204/SPC/cervarix/

6. De Vuyst, H., Clifford, GM., Nascimento, MC., et al. Prevalence and type distribution of human papillomavirus in carcinoma and intraepithelial neoplasia of the vulva, vagina and anus: a meta-analysis. Int J Cancer, 2009, 124(7), p. 1626–1636.

7. 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), p. 1793–1802.

8. Driák, D., Sehnal, B. Význam infekcí způsobených lidskými papilomaviry. Čas Lék čes, 2013, 152, s. 15–19.

9. Eggertson, L. Three provinces to study 2-dose HPV vaccine. CMAJ, 2007, 177(5), p. 444–445.

10. Fehrmann, F., Laimins, LA. Human papillomaviruses: targeting differentiating epithelial cells for malignant transformation. Oncogene, 2003, 22, p. 5201–5207.

11. Ferlay, J., Shin, HR., Bray, F., et al. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer, 2010, 127(12), p. 2893–2917.

12. Kreimer, AR., Rodriguez, AC., Hildesheim, A., et al. Proof-of-principle evaluation of the efficacy of fewer than three doses of a bivalent HPV16/18 vaccine. J Natl Cancer Inst, 2011, 103(19), p. 1444–1451.

13. Lazcano-Ponce, E., Stanley, M., Muñoz, N., et al. Overcoming barriers to HPV vaccination: non-inferiority of antibody response to human papillomavirus 16/18 vaccine in adolescents vaccinated with a two-dose vs. a three-dose schedule at 21 months. Vaccine, 2014, 32(6), p. 725–732.

14. Malik, ZA., Hailpern, SM., Burk, RD. Persistent antibodies to HPV virus-like particles following natural infection are protective against subsequent cervicovaginal infection with related and unrelated HPV. Viral Immunol, 2009, 22(6), p. 445–449.

15. Muñoz, N., Bosch, FX., de Sanjose, S., et al. Epidemiologic classification of human papillomavirus types associated with cervical cancer. N Engl J Med, 2003, 348, p. 518–527.

16. Parkin, DM., Bray, F. The burden of HPV-related cancers. Vaccine, 2006, 24 (Suppl 3), p. 11–25.

17. 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, p. 564–571.

18. Puthanakit, T., Schwarz, T., Esposito, S., et al. Immune response to a 2-dose schedule of the HPV-16/18 AS04–-adjuvanted vaccine in girls (9–14) versus 3 doses in women (15–25): a randomized trial. Abstract. Oral presentation. Eurogin, 2013, 3.–6. 11. 2013, Florencie, Itálie.

19. Ricci, S. What does ‚non-inferior to‘ really mean? A clinician thinking out loud. Cerebrovasc Dis, 2010, 29, p. 607–608.

20. Romanowski, B., Schwarz, T., Ferguson, L., et al. Immune response to the HPV-16/18 AS04-adjuvanted vaccine administered as a 2-dose or 3-dose schedule up to 4 years after vaccination. Abstract. Poster. Eurogin, 2013, 3.–6. 11. 2013, Florencie, Itálie.

21. Romanowski, B., Schwarz, TF., Ferguson, LM., et al. Immune response to the HPV-16/18 AS04-adjuvanted vaccine administered as a 2-dose or 3-dose schedule up to 4 years after vaccination: Results from a randomized study. Hum Vaccin Immunother, 2014, 10(5), p. 1374–1386.

22. Sabin Vaccine Institute. Price is the Main Barrier to Wider Use of Papillomavirus Vaccine. Available from: http://www.sabin.org/updates/news/price-main-barrier-wider-use-papillomavirus-vaccine.

23. 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.

24. Schwarz, TF. ASO4-adjuvanted human papillomavirus - 16/18 vaccination: recent advances in cervical cancer prevention. Expert Rev Vaccines, 2008, 7, p. 1465–1473.

25. Silgard, SPC (Summary of Product Characteristics, Souhn údajů o přípravku). Available from: http://www.medicines.org.uk/emc/medicine/19016/SPC/gardasil/

26. Spitzer, M. Human papillomavirus: epidemiology, natural history, and clinical sequelae. OBG Management, 2006, 18, p. S5–S10.

27. Tjalma, WA., Fiander, A., Reich, O., et al. Differences in human papillomavirus type distribution in high-grade cervical intraepithelial neoplasia and invasive cervical cancer in Europe Int J Cancer, 2013, 132, p. 854–867.

28. Trollfors, B. Human papillomavirus vaccines: an outsider´s point of view. Expert Rev Vaccines, 2008, 7, p. 1131–1133.

29. Viscidi, RP., Schiffman, M., Hildesheim, A., et al. Sero-reactivity 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), p. 324–327.

30. Vonka, V., Kanka, J., Hirsch, I., et al. Prospective study on the relationship between cervical neoplasia and herpes simplex type-2 virus. II. Herpes simplex type-2 antibody presence in sera taken at enrollment. Int J Cancer, 1984, 33(1), p. 61–66.

31. Walboomers, JM., Jacobs, MV., Manos, MM., et al. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol, 1999, 189(1), p. 12–19.

32. White, EA., Sowa, ME., Tan, MJ., et al. Systematic identification of interactions between host cell proteins and E7 oncoproteins from diverse human papillomaviruses. Proc Natl Acad Sci USA, 2012, 109, p.260–7.

33. zur Hausen, H. Condylomata acuminata and human genital cancer. Cancer Res, 1976, 36, p. 794.

34. zur Hausen, H. Human genital cancer: synergism between two virus infections or synergism between a virus infection and initiating events? Lancet, 1982, 2(8312), p. 1370–1372.