Journal of Adolescent Health
Volume 46, Issue 5 , Pages 414-421 , May 2010

Safety and Immunogenicity of the HPV-16/18 AS04-Adjuvanted Vaccine: A Randomized, Controlled Trial in Adolescent Girls

  • Doris M. Rivera Medina, M.D.

      Affiliations

    • Organización para el Desarrollo y la Investigación Salud en Honduras, Tegucigalpa, Honduras
    • Corresponding Author InformationAddress correspondence to: Doris M. Rivera Medina, M.D., Organización para el Desarrollo y la Investigación Salud en Honduras, Colonia Miraflores Sur, Bloque 35 Casa 1944, Tegucigalpa, Honduras.
    • ,
  • Alejandra Valencia, M.D.

      Affiliations

    • Fundación Santa Fe de Bogotá, Bogotá, Colombia
    • ,
  • Alet de Velasquez, M.D.

      Affiliations

    • Policlínica Santiago Barraza, Panamá City, Panamá
    • ,
  • Li-Min Huang, M.D., Ph.D.

      Affiliations

    • National Taiwan University Hospital, Taipei, Taiwan
    • ,
  • Roman Prymula, M.D.

      Affiliations

    • Faculty of Military Health Sciences, Hradec Kralove, Czech Republic
    • ,
  • Jose García-Sicilia, M.D.

      Affiliations

    • Hospital la Paz, Madrid, Spain
    • ,
  • Lars Rombo, M.D.

      Affiliations

    • Department of Infectious Diseases, Eskilstuna and Karolinska Institute, Stockholm, Sweden
    • Center for Clinical Research, Sörmland County Council, Sweden
    • ,
  • Marie Pierre P. David, M.Sc.

      Affiliations

    • GlaxoSmithKline Biologicals, Rixensart, Belgium
    • ,
  • Dominique Descamps, M.D.

      Affiliations

    • GlaxoSmithKline Biologicals, Rixensart, Belgium
    • ,
  • Karin Hardt, Ph.D.

      Affiliations

    • GlaxoSmithKline Biologicals, Rixensart, Belgium
    • ,
  • Gary Dubin, M.D.

      Affiliations

    • GlaxoSmithKline Biologicals, King of Prussia, Pennsylvania
    • ,
  • HPV-013 Study Group

Received 20 October 2009 ,Accepted 4 February 2010.

References 

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  2. Parkin DM, Bray F, Ferlay J, et al. Global cancer statistics, 2002. CA Cancer J Clin. 2005;55:74–108
  3. Muñoz N, Bosch FX, De Sanjosé S, et al. Epidemiologic classification of human papillomavirus types associated with cervical cancer. N Engl J Med. 2003;348:518–527
  4. 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–K16
  5. Brown DR, Shew ML, Qadadri B, et al. A longitudinal study of genital human papillomavirus infection in a cohort of closely followed adolescent women. J Infect Dis. 2005;191:182–192
  6. Moscicki AB. HPV infections in adolescents. Dis Markers. 2007;23:229–234
  7. Collins S, Mazloomzadeh S, Winter H, et al. High incidence of cervical human papillomavirus infection in women during their first sexual relationship. BJOG. 2002;109:96–98
  8. Harper DM, Franco EL, Wheeler CM, 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. 2004;364:1757–1765
  9. 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 randomized control trial. Lancet. 2006;367:1247–1255
  10. Paavonen J, Jenkins D, Bosch FX, et al. Efficacy of a prophylactic adjuvanted bivalent L1 virus-like-particle vaccine against infection with human papillomavirus types 16 and 18 in young women: An interim analysis of a phase III double-blind, randomized controlled trial. Lancet. 2007;369:2161–2170
  11. Paavonen J, Naud P, J Salmerón 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, randomized study in young women. Lancet. 2009;374:301–314
  12. GlaxoSmithKline Vaccine HPV-007 Study Group . 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;374:1975–1985
  13. Pedersen C, Petaja T, Strauss G, et al. Immunization of adolescent females with human papillomavirus type 16 and 18 L1 virus-like particle vaccine containing AS04 adjuvant. J Adolesc Health. 2007;40:564–571
  14. 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;5:332–340
  15. Verstraeten T, Descamps D, David MP, et al. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008;26:6630–6638
  16. Garçon N, Chomez P, Van Mechelen M. GlaxoSmithKline Adjuvant Systems in vaccines: Concepts, achievements and perspectives. Expert Rev Vaccines. 2007;6:723–739
  17. Giannini SL, Hanon E, Moris P, et al. Enhanced humoral and memory B cell immunity using HPV16/18 L1 VLP vaccine formulated with the MPL/aluminium salt combination (AS04) compared to aluminium salt only. Vaccine. 2006;24:5937–5949
  18. 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;115(3 Suppl):S1–S6

 Members of the study group are listed in the Acknowledgements.

 Conflict of interest: D Descamps, K Hardt, M-P David and G Dubin are employees of GlaxoSmithKline Biologicals.

PII: S1054-139X(10)00102-3

doi: 10.1016/j.jadohealth.2010.02.006

Journal of Adolescent Health
Volume 46, Issue 5 , Pages 414-421 , May 2010

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