Human papillomavirus-16/18 AS04-adjuvanted vaccine (Cervarix®): A guide to its two-dose schedule in girls aged 9-14 years in the EU

Pediatric Drugs

Volumn 16, Issue 3, 2014, Pages 247-253

  Lyseng Williamson, Katherine A ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

WART VIRUS VACCINE; HUMAN PAPILLOMAVIRUS VACCINE, L1 TYPE 16, 18;

CLINICAL EFFECTIVENESS; DOSAGE SCHEDULE COMPARISON; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; HUMAN; HUMAN PAPILLOMAVIRUS TYPE 16; HUMAN PAPILLOMAVIRUS TYPE 18; IMMUNOGENICITY; PRECANCER; PRIORITY JOURNAL; REVIEW; UTERINE CERVIX CANCER; VACCINATION; ADOLESCENT; CHILD; FEMALE; IMMUNIZATION; PAPILLOMAVIRUS INFECTIONS; TREATMENT OUTCOME; UTERINE CERVICAL NEOPLASMS;

ADOLESCENT; CHILD; FEMALE; HUMANS; IMMUNIZATION SCHEDULE; PAPILLOMAVIRUS INFECTIONS; PAPILLOMAVIRUS VACCINES; TREATMENT OUTCOME; UTERINE CERVICAL NEOPLASMS;

EID: 84902359019     PISSN: 11745878     EISSN: 11792019     Source Type: Journal    
DOI: 10.1007/s40272-014-0071-7     Document Type: Review

References (36)

1. Szarewski A. HPV vaccination and cervical cancer. Curr Oncol Rep. 2012;14(6):559-67.
2. Asiaf A, Ahmad ST, Mohammad SO, et al. Review of the current knowledge on the epidemiology, pathogenesis, and prevention of human papillomavirus infection. Eur J Cancer Prev. 2013 (Epub ahead of print).
3. 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.
4. Alemany L, de Sanjosé S, Tous S, et al. Time trends of human papillomavirus types in invasive cervical cancer, from 1940 to 2007. Int J Cancer. 2013. doi:10.1002/ijc.28636.
5. Basu P, Banerjee D, Singh P, et al. Efficacy and safety of human papillomavirus vaccine for primary prevention of cervical cancer: a review of evidence from phase III trials and national programs. South Asian J Cancer. 2013;2(4):187-92.
6. Russell M, Raheja V, Jaiyesimi R. Human papillomavirus vaccination in adolescence. Perspect Public Health. 2013;133(6):320-4.
7. Hibbitts S, Tristram A, Beer H, et al. UK population based study to predict impact of HPV vaccination. J Clin Virol. 2014;59(2):109-14.
8. Cervarix suspension for injection. Human papillomavirus vaccine [types 16,18] (recombinant, adjuvanted, adsorbed): summary of product characteristics. London: European Medicines Agency; 2014.
9. Gardasil, suspension for injection. Human papillomavirus vaccine [types 6,11,16,18] (recombinant, adsorbed): summary of product characteristics. London: European Medicines Agency; 2013.
10. McKeage K, Romanowski B. AS04-adjuvanted human papillomavirus (HPV) types 16 and 18 vaccine (Cervarix): a review of its use in the prevention of premalignant cervical lesions and cervical cancer causally related to certain oncogenic HPV types. Drugs. 2011;71(4):465-88.
11. Fagot J-P, Boutrelle A, Ricordeau P, et al. HPV vaccination in France: uptake, costs and issues for the National Health Insurance. Vaccine. 2011;29(19):3610-6.
12. Laz TH, Rahman M, Berenson AB. An update on human papillomavirus vaccine uptake among 11-17 year old girls in the United States: National Health Interview Survey, 2010. Vaccine. 2012;30(24):3534-40.
13. 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(29):591-5.
14. 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.
15. Garçon N, Morel S, Didierlaurent A, et al. Development of an AS04-adjuvanted HPV vaccine with the adjuvant system approach. Biodrugs. 2011;25(4):217-26.
16. GlaxoSmithKline Vaccine HPV-007 Study Group, Romanowski B, Colares de Borba P, 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):1975-85.
17. 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 [published erratum appears in Lancet 2010; 376:1054]. Lancet. 2009;374(9686):301-14.
18. 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(3):390-7.
19. Aregay M, Shkedy Z, Molenberghs G, et al. Model-based estimates of long-term persistence of induced HPV antibodies: a flexible subject-specific approach. J Biopharm Stat. 2013;23(6):1228-48.
20. Einstein MH, Baron M, Levin MJ, et al. Comparison of the immunogenicity of the human papillomavirus (HPV)-16/18 vaccine and the HPV-6/11/16/18 vaccine for oncogenic nonvaccine types HPV-31 and HPV-45 in healthy women aged 18-45 years. Hum Vaccin. 2011;7(12):1359-73.
21. 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):1343-58.
22. Draper E, Bissett SL, Howell-Jones R, et al. A randomized, observer-blinded immunogenicity trial of Cervarix® and Gardasil® human papillomavirus vaccines in 12-15 year old girls. PLoS ONE. 2013;8(5):e61825.
23. Malagon T, Drolet M, Boily M-C, et al. Cross-protective efficacy of two human papillomavirus vaccines: a systematic review and meta-analysis. Lancet Infect Dis. 2012;12(10):781-9.
24. Kemp TJ, Hildesheim A, Safaeian M, et al. HPV16/18 L1 VLP vaccine induces cross-neutralizing antibodies that may mediate cross-protection. Vaccine. 2011;29(11):2011-4.
25. 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):564-71. (Pubitemid 46771257)
26. Petäjä T, Pedersen C, Poder A, et al. Long-term persistence of systemic and mucosal immune response to HPV-16/18 AS04-adjuvanted vaccine in preteen/adolescent girls and young women. Int J Cancer. 2011;129(9):2147-57.
27. Romanowski B, Schwarz TF, Ferguson LM, et al. Immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine administered as a 2-dose schedule compared with the licensed 3-dose schedule: results from a randomized study. Hum Vaccin. 2011;7(12):1374-86.
28. Puthanakit T, Schwarz T, Esposito S, et al. Immune responses 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 randomised trial [abstract no. IW-1-5]. EUROGIN 2013 International Multidisciplinary Congress, Florence; 2013.
29. 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):725-32.
30. 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 (Epub ahead of print).
31. Wheeler CM, Castellsague X, Garland SM, et al. Cross-protective efficacy of HPV-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by non-vaccine oncogenic HPV types: 4-year end-of-study analysis of the randomised, double-blind PATRICIA trial. Lancet Oncol. 2012;13(1):100-10.
32. 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(1):89-99.
33. 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):1444-51.
34. Herrero R, Wacholder S, Rodríguez AC, et al. Prevention of persistent human papillomavirus infection by an HPV16/18 vaccine: a community-based randomized clinical trial in Guanacaste, Costa Rica. Cancer Discov. 2011;1(5):408-19.
35. Angelo M-G, David M-P, Zima J, et al. Pooled analysis of large and long-term safety data from the human papillomavirus-16/18-AS04-adjuvanted vaccine clinical trial programme. Pharmacoepidemiol Drug Saf. doi:10.1002/pds.3554.
36. Cervical cancer, human papillomavirus (HPV), and HPV vaccines: key points for policy-makers and health professionals. Geneva: WHO Document Production Services; 2008.