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Human Papillomavirus Types 16 and 18 Vaccine (Recombinant, AS04 Adjuvanted Adsorbed) [Cervarix™]

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Abstract

  • ▴ Cervarix™ is a prophylactic vaccine comprised of a mixture of virus-like particles derived from the L1 capsid proteins of human papillomavirus (HPV) types 16 and 18 formulated with the AS04 adjuvant system. It is administered by intramuscular injection as a three-dose vaccine regimen at 0, 1 and 6 months. The vaccine is indicated for the prevention of high-grade cervical intraepithelial neoplasia (CIN 2 and CIN 3) and cervical cancer causally related to HPV types 16 and 18.

  • ▴ In randomized, double-blind, phase II or III trials in >19 000 women aged 15–25 years, the HPV 16/18 vaccine showed high efficacy in preventing CIN 2+ associated with HPV 16/18. Cross-protection against new incident or 6-month persistent HPV 45 or HPV 31 infection was also evident. Phase II follow-up was for at least 5.5 years, and the phase III interim analysis was at ≈15 months after the first vaccine dose.

  • ▴ In a bridging study, in adolescent girls aged 10–14 years, the HPV 16/18 vaccine induced twice the already high antibody titres as it did in young women (aged 15–25 years). The immune response in older women (aged 26–55 years) at 24 months in another study was ≥8-fold higher than antibody levels reported in younger age groups. Anti-HPV 16/18 antibody responses were greater with an AS04-adjuvanted HPV 16/18 vaccine than with an aluminium salt-adjuvanted formulation.

  • ▴ The HPV 16/18 vaccine was generally well tolerated and injection-site reactions were the most common vaccine-related adverse events reported.

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  1. The use of trade names is for product identification purposes only and does not imply endorsement.

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Acknowledgements and Disclosures

This manuscript was reviewed by: A. Ferenczy, Department of Pathology, Jewish General Hospital, Montreal, Quebec, Canada; J. Paavonen, Department of Obstetrics and Gynaecology, University Hospital, Helsinki, Finland.

The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was also offered an opportunity to comment on this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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

    Susan J. Keam

  2. Wolters Kluwer Health, Conshohocken, Pennsylvania, USA

    Susan J. Keam

  3. Women’s and Gender Studies Program, Dartmouth College, Hanover, New Hampshire, USA

    Diane M. Harper

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Keam, S.J., Harper, D.M. Human Papillomavirus Types 16 and 18 Vaccine (Recombinant, AS04 Adjuvanted Adsorbed) [Cervarix™]. Drugs 68, 359–372 (2008). https://doi.org/10.2165/00003495-200868030-00007

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