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Short Report

Long-term effectiveness of the nine-valent human papillomavirus vaccine in Scandinavian women: interim analysis after 8 years of follow-up

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Pages 943-949 | Received 31 Jul 2020, Accepted 11 Oct 2020, Published online: 16 Dec 2020

References

  • Huh WK, Joura EA, Giuliano AR, Iversen OE, de Andrade RP, Ault KA, Bartholomew D, Cestero RM, Fedrizzi EN, Hirschberg AL, et al. Final efficacy, immunogenicity, and safety analyses of a nine-valent human papillomavirus vaccine in women aged 16-26 years: a randomised, double-blind trial. Lancet. 2017;390:2143–59.
  • Joura EA, Giuliano AR, Iversen O-E, Bouchard C, Mao C, Mehlsen J, Moreira ED, Ngan Y, Petersen LK, Lazcano-Ponce E, et al. A 9-valent HPV vaccine against infection and intraepithelial neoplasia in women. N Engl J Med. 2015;372(8):711–23. doi:10.1056/NEJMoa1405044.
  • Giuliano AR, Joura EA, Garland SM, Huh WK, Iversen O-E, Kjaer SK, Ferenczy A, Kurman RJ, Ronnett BM, Stoler MH, et al. Nine-valent HPV vaccine efficacy against related diseases and definitive therapy: comparison with historic placebo population. Gynecol Oncol. 2019;154(1):110–17. doi:10.1016/j.ygyno.2019.03.253.
  • Luxembourg A, Kjaer SK, Nygard M, Ellison MC, Group T, Marshall JB, Radley D, Saah A. Design of a long-term follow-up effectiveness, immunogenicity and safety study of women who received the 9-valent human papillomavirus vaccine. Contemp Clin Trials. 2017;52:54–61. doi:10.1016/j.cct.2016.10.006.
  • Luxembourg A, Bautista O, Moeller E, Ritter M, Chen J. Design of a large outcome trial for a multivalent human papillomavirus L1 virus-like particle vaccine. Contemp Clin Trials. 2015;42:18–25. doi:10.1016/j.cct.2015.02.009.
  • Chen YH, Gesser R, Luxembourg A. A seamless phase IIB/III adaptive outcome trial: design rationale and implementation challenges. Clin Trials. 2015;12(1):84–90. doi:10.1177/1740774514552110.
  • Else EA, Swoyer R, Zhang Y, Taddeo FJ, Bryan JT, Lawson J, Van Hyfte I, Roberts CC. Comparison of real-time multiplex human papillomavirus (HPV) PCR assays with INNO-LiPA HPV genotyping extra assay. J Clin Microbiol. 2011;49(5):1907–12. doi:10.1128/JCM.00236-10.
  • Roberts CC, Swoyer R, Bryan JT, Taddeo FJ. Comparison of real-time multiplex human papillomavirus (HPV) PCR assays with the linear array HPV genotyping PCR assay and influence of DNA extraction method on HPV detection. J Clin Microbiol. 2011;49:1899–906.
  • Kjaer SK, Tran TN, Sparen P, Tryggvadottir L, Munk C, Dasbach E, Liaw K-L, Nygård J, Nygård M. The burden of genital warts: a study of nearly 70,000 women from the general female population in the 4 Nordic countries. J Infect Dis. 2007;196(10):1447–54. doi:10.1086/522863.
  • Castellsagué X, Ault KA, Bosch FX, Brown D, Cuzick J, Ferris DG, Joura EA, Garland SM, Giuliano AR, Hernandez-Avila M, et al. Human papillomavirus detection in cervical neoplasia attributed to 12 high-risk human papillomavirus genotypes by region. Papillomavirus Res. 2016;2:61–69. doi:10.1016/j.pvr.2016.03.002.
  • Kjaer SK, Nygård M, Sundström K, Dillner J, Tryggvadottir L, Munk C, Berger S, Enerly E, Hortlund M, Ágústsson ÁI, et al. Final analysis of a 14-year long-term follow-up study of the effectiveness and immunogenicity of the quadrivalent human papillomavirus vaccine in women from four Nordic countries. EClinicalMedicine. 2020;23:100401. doi:10.1016/j.eclinm.2020.100401.
  • World Health Organization (WHO). Guidelines to assure the quality, safety and efficacy of recombinant HPV virus-like particle vaccines. 2006 [Accessed 2020 Jun 30]. http://screening.iarc.fr/doc/WHO_vaccine_guidelines_2006.pdf.
  • Luxembourg A, Moeller E. 9-Valent human papillomavirus vaccine: a review of the clinical development program. Expert Rev Vaccines. 2017;16:1119–39. doi:10.1080/14760584.2017.1383158.
  • Orumaa M, Leinonen MK, Campbell S, Møller B, Myklebust TÅ, Nygård M. Recent increase in incidence of cervical precancerous lesions in Norway: nationwide study from 1992 to 2016. Int J Cancer. 2019;145:2629–38. doi:10.1002/ijc.32195.
  • Burger EA, Smith MA, Killen J, Sy S, Simms KT, Canfell K, Kim JJ. Projected time to elimination of cervical cancer in the USA: a comparative modelling study. Lancet Public Health. 2020;5(4):e213–e222. doi:10.1016/S2468-2667(20)30006-2.
  • Pedersen K, Burger EA, Nygard M, Kristiansen IS, Kim JJ. Adapting cervical cancer screening for women vaccinated against human papillomavirus infections: the value of stratifying guidelines. Eur J Cancer. 2018;91:68–75. doi:10.1016/j.ejca.2017.12.018.