Skip to main content
SpringerLink
Log in

AS04-adjuvanted human papillomavirus types 16/18 vaccine (Cervarix®): a guide to its use

  • Clinical Questions & Answers on Drugs
  • Published:
Drugs & Therapy Perspectives Aims and scope Submit manuscript

Abstract

The AS04-adjuvanted human papillomavirus (HPV) 16/18 vaccine is indicated for the prevention of premalignant cervical lesions and cervical cancer causally related to certain oncogenic HPV types. The vaccine elicits a high immunogenic response and is highly protective against cervical intraepithelial neoplasia and infection. It is also generally well tolerated, and cost effective from a healthcare payer perspective.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Table I

Similar content being viewed by others

References

  1. 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

    Article  PubMed  CAS  Google Scholar 

  2. Cervarix suspension for injection. Human papillomavirus vaccine [types 16,18] (recombinant, adjuvanted, adsorbed): summary of product characteristics. London: European Medicines Agency, 2011 Sep 30

    Google Scholar 

  3. CHMP post-authorisation summary of opinion for Cervarix. London: European Medicines Agency, 2011 Oct 21

  4. 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 Sep; 110(3 Suppl. 1): S1–10

    Article  PubMed  CAS  Google Scholar 

  5. Moscicki B, Wheeler CM, Romanowski B, et al. Anamnestic response elicited by a fourth dose of the HPV-16/18 AS04-adjuvanted vaccine in young women [abstract no. SS 11-6]. European Research Organisation on Genital Infection and Neoplasia (EUROGIN); 2010 Feb 17–20; Monte Carlo

  6. The 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 Dec 12; 374(9706): 1975–85

    Article  PubMed  CAS  Google Scholar 

  7. 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 Jul 25; 374(9686): 301–14

    Article  PubMed  CAS  Google Scholar 

  8. Naud P, Roteli-Martins CM, De Carvalho N, et al. HPV-16/18 vaccine: sustained immunogenicity and efficacy to 9.4 years [abstract no. O-18.04]. 27th International Papillomavirus Conference; 2011 Sep 17–22; Berlin

  9. 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 Dec; 115(3 Suppl. 1): S1–6

    Article  PubMed  CAS  Google Scholar 

  10. 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 non-vaccine types HPV-31 and HPV-45 in healthy women aged 18–45 years. Hum Vaccin 2011 Dec; 7(12): 1359–73

    Article  PubMed  CAS  Google Scholar 

  11. Kemp TJ, Hildesheim A, Safaeian M, et al. HPV16/18 L1 VLP vaccine induces cross-neutralizing antibodies that may mediate cross-protection. Vaccine 2011 Mar 3; 29(11): 2011–4

    Article  PubMed  CAS  Google Scholar 

  12. 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): 705–19

    Article  PubMed  CAS  Google Scholar 

  13. Einstein MH, on behalf of the HPV-010 Study Group. Comparison of immunogenicity of two prophylactic human papillomavirus (HPV) vaccines at month 36 [abstract no. SS 19-3]. European Research Organisation on General Infection and Neoplasia (EUROGIN) 2011 Congress; 2011 May 8–11; Lisbon

  14. 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 Jan; 13(1): 89–99

    Article  PubMed  CAS  Google Scholar 

  15. Wheeler CM, Castellsagué 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 Jan; 13(1): 100–10

    Article  PubMed  CAS  Google Scholar 

  16. 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 May; 5(5): 332–40

    Article  PubMed  Google Scholar 

  17. Labadie J. Postlicensure safety evaluation of human papilloma virus vaccines. Int J Risk Saf Med 2011; 23(2): 103–12

    PubMed  Google Scholar 

  18. Koleva D, De Compadri P, Padula A, et al. Economic evaluation of human papilloma virus vaccination in the European Union: a critical review. Intern Emerg Med 2011 Apr; 6(2): 163–74

    Article  PubMed  Google Scholar 

  19. Torvinen S, Nieminen P, Lehtinen M, et al. Cost effectiveness of prophylactic HPV 16/18 vaccination in Finland: results from a modelling exercise. J Med Econ 2010; 13(2): 284–94

    Article  PubMed  Google Scholar 

  20. Demarteau N, Detournay B, Tehard B, et al. A generally applicable cost-effectiveness model for the evaluation of vaccines against cervical cancer. Int J Public Health 2011 Apr; 56(2): 153–62

    Article  PubMed  Google Scholar 

  21. Dee A, Howell F. A cost-utility analysis of adding a bivalent or quadrivalent HPV vaccine to the Irish cervical screening programme. Eur J Public Health 2010; 20(2): 213–9

    Article  PubMed  Google Scholar 

  22. La Torre G, de Waure C, Chiaradia G, et al. The Health Technology Assessment of bivalent HPV vaccine Cervarix® in Italy. Vaccine 2010 Apr 26; 28(19): 3379–84

    Article  PubMed  Google Scholar 

  23. Lee VJ, Tay SK, Teoh YL, et al. Cost-effectiveness of different human papillomavirus vaccines in Singapore. BMC Public Health 2011 Mar 31;11: 203

    Article  PubMed  Google Scholar 

  24. Jit M, Chapman R, Hughes O, et al. Comparing bivalent and quadrivalent human papillomavirus vaccines: economic evaluation based on transmission model. BMJ 2011 Sep 27; 343: d5775

    Article  PubMed  Google Scholar 

  25. Demarteau N, Standaert B. Modelling the economic value of cross- and sustained-protection in vaccines against cervical cancer. J Med Econ 2010; 13(2): 324–38

    Article  PubMed  Google Scholar 

  26. Scarbrough Lefebvre CD, Van Kriekinge G, Gonçalves MA, et al. Appraisal of the burden of genital warts from a healthcare and individual patient perspective. Public Health 2011 Jul; 125(7): 464–75

    Article  Google Scholar 

  27. Aubin F, Prétet JL, Jacquard AC, et al. Human papillomavirus genotype distribution in external acuminata condylomata: a Large French National Study (EDiTH IV). Clin Infect Dis 2008 Sep 1; 47(5): 610–5

    Article  PubMed  Google Scholar 

  28. Cervical cancer, human papillomavirus (HPV), and HPV vaccines: key points for policy-makers and health professionals. Geneva: WHO Document Production Services, 2008

Download references

Acknowledgements and Disclosures

This article was updated from Drugs 2011; 71 (4): 465-88[1] by Adis editors and medical writers, and was reviewed by M. Baraka, Faculty of Medicine and Pharmacy, Vrije Universiteit Brussel, Brussels, Belgium; M. Diaz, Unit of Infections and Cancer, Catalan Institute of Oncology, Barcelona, Spain; J. Garcia-Sicilia, Department of Paediatrics, La Paz Hospital, Madrid, Spain; S. Saluja, Consultant in Internal Medicine, Saran Ashram, Agra, India.

The preparation of these articles was not supported by external funding. The manufacturer of the agent under review was offered an opportunity to comment on the articles during the peer review process; changes based on any comments received were made by the authors on the basis of scientific and editorial merit.

Author information

Authors and Affiliations

  1. Adis, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore, Auckland, 0754, New Zealand

    Katherine A. Lyseng-Williamson & Kate McKeage

Authors
  1. Katherine A. Lyseng-Williamson
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Kate McKeage
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Katherine A. Lyseng-Williamson.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Lyseng-Williamson, K.A., McKeage, K. AS04-adjuvanted human papillomavirus types 16/18 vaccine (Cervarix®): a guide to its use. Drugs Ther Perspect 28, 1–6 (2012). https://doi.org/10.2165/11208830-000000000-00000

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.2165/11208830-000000000-00000

Keywords

Search

Navigation