3,107
Views
55
CrossRef citations to date
0
Altmetric
Research Papers

Sustained immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine administered as a two-dose schedule in adolescent girls: Five-year clinical data and modeling predictions from a randomized study

, , , , , , , , , & show all
Pages 20-29 | Received 18 Mar 2015, Accepted 18 Jun 2015, Published online: 04 Dec 2015

References

  • Paavonen J, Jenkins D, Bosch FX, Naud P, Salmeron J, Wheeler CM, Chow SN, Apter DL, Kitchener HC, Castellsagué X, 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, randomised controlled trial. Lancet 2007; 369: 2161-70; PMID:17602732; http://dx.doi.org/10.1016/S0140-6736(07)60946-5
  • Paavonen J, Naud P, Salmeron J, Wheeler CM, Chow SN, Apter D, Kitchener H, Castellsagué X, Teixeira JC, Skinner SR, 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. Lancet 2009; 374: 301-14; PMID:19586656; http://dx.doi.org/10.1016/S0140-6736(09)61248-4
  • Lehtinen M, Paavonen J, Wheeler CM, Jaisamrarn U, Garland SM, Castellsagué X, Skinner SR, Apter D, Naud P, Salmeron J, 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: 89-99; PMID:22075171; http://dx.doi.org/10.1016/S1470-2045(11)70286-8
  • Wheeler CM, Castellsagué X, Garland SM, Szarewski A, Paavonen J, Naud P, Salmeron J, Chow SN, Apter D, Kitchener H, 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: 100-10; PMID:22075170; http://dx.doi.org/10.1016/S1470-2045(11)70287-X
  • Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine 2008; 26: 6630-8; PMID:18845199; http://dx.doi.org/10.1016/j.vaccine.2008.09.049
  • Descamps D, Hardt K, Spiessens B, Izurieta P, Verstraeten T, Breuer T, Dubin G. 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: 332-40; PMID:19221517; http://dx.doi.org/10.4161/hv.5.5.7211
  • Angelo MG, David MP, Zima J, Baril L, Dubin G, Arellano F, Struyf F. Pooled analysis of large and long-term safety data from the human papillomavirus-16/18-AS04-adjuvanted vaccine clinical trial programme. Pharmacoepidemiol Drug Saf 2014; 23: 466-79; PMID:24644063; http://dx.doi.org/10.1002/pds.3554
  • Goldie SJ, Gaffikin L, Goldhaber-Fiebert JD, Gordillo-Tobar A, Levin C, Mahe C, Wright TC. Cost-effectiveness of cervical-cancer screening in five developing countries. N Engl J Med 2005; 353: 2158-68; PMID:16291985; http://dx.doi.org/10.1056/NEJMsa044278
  • Deleré Y, Böhmer MM, Walter D, Wichmann O. HPV vaccination coverage among women aged 18-20 years in Germany three years after recommendation of HPV vaccination for adolescent girls: results from a cross-sectional survey. Hum Vaccin Immunother 2013; 9: 1706-11; http://dx.doi.org/10.4161/hv.24904
  • Stokley S, Jeyarajah J, Yankey D, Cano M, Gee J, Roark J, Curtis RC, Markowitz L. Human papillomavirus vaccination coverage among adolescents, 2007-2013, and post-licensure vaccine safety monitoring, 2006-2014-United States. MMWR Morb Mortal Wkly Rep 2014; 63: 620-4; PMID:25055185
  • Public Health England. Annual HPV vaccine coverage in England: 2012 to 2013. Published by Public Health England on 10 December 2013. Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/266190/HPV_AnnualDataTable2012_13_SHA_acc2.pdf. Accessed 11 December 2014
  • Colucci R, Hryniuk W, Savage C. HPV vaccination programs in Canada. Are we hitting the mark? Cancer Advocacy Coalition of Canada. Report Card on Cancer in Canada 2008; 11: 7-10
  • Pedersen C, Petaja T, Strauss G, Rumke HC, Poder A, Richardus JH, Spiessens B, Descamps D, Hardt K, Lehtinen M, 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: 564-71; PMID:17531764; http://dx.doi.org/10.1016/j.jadohealth.2007.02.015
  • Block SL, Nolan T, Sattler C, Barr E, Giacoletti KE, Marchant CD, Castellsague X, Rusche SA, Lukac S, Bryan JT, et al. Comparison of the immunogenicity and reactogenicity of a prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in male and female adolescents and young adult women. Pediatrics 2006; 118: 2135-45; PMID:17079588; http://dx.doi.org/10.1542/peds.2006-0461
  • Harper DM, Franco EL, Wheeler C, Ferris DG, Jenkins D, Schuind A, Zahaf T, Innis B, Naud P, De Carvalho NS, 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 randomised controlled trial. Lancet 2004; 364: 1757-65; PMID:15541448; http://dx.doi.org/10.1016/S0140-6736(04)17398-4
  • Harper DM, Franco EL, Wheeler CM, Moscicki AB, Romanowski B, Roteli-Martins CM, Jenkins D, Schuind A, Costa Clemens SA, Dubin G. 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 randomised control trial. Lancet 2006; 367: 1247-55; PMID:16631880; http://dx.doi.org/10.1016/S0140-6736(06)68439-0
  • FUTURE II Study Group. Prophylactic efficacy of a quadrivalent human papillomavirus (HPV) vaccine in women with virological evidence of HPV infection. J Infect Dis 2007; 196: 1438-46; PMID:18008221; http://dx.doi.org/10.1086/522864
  • Ault KA, FUTURE II Study Group. Effect of prophylactic human papillomavirus L1 virus-like-particle vaccine on risk of cervical intraepithelial neoplasia grade 2, grade 3, and adenocarcinoma in situ: a combined analysis of four randomised clinical trials. Lancet 2007; 369: 1861-8; PMID:17544766; http://dx.doi.org/10.1016/S0140-6736(07)60852-6
  • Romanowski B, Schwarz TF, Ferguson LM, Peters K, Dionne M, Schulze K, Ramjattan B, Hillemanns P, Catteau G, Dobbelaere K, et al. Immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine administered as a 2-dose schedule compared to the licensed 3-dose schedule: Results from a randomized study. Hum Vaccin 2011; 7: 1374-86; PMID:22048171; http://dx.doi.org/10.4161/hv.7.12.18322
  • Romanowski B, Schwarz TF, Ferguson LM, Ferguson M, Peters K, Dionne M, Schulze K, Ramjattan B, Hillemanns P, Behre U, 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; 10: 1155-65; PMID:24576907; http://dx.doi.org/10.4161/hv.28022
  • The 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: 1975-85; PMID:19962185; http://dx.doi.org/10.1016/S0140-6736(09)61567-1
  • Petaja T, Pedersen C, Poder A, Strauss G, Catteau G, Thomas F, Lehtinen M, Descamps D. 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: 2147-57; PMID:21190190; http://dx.doi.org/10.1002/ijc.25887
  • Schwarz TF, Huang LM, Medina DM, Valencia A, Lin TY, Behre U, Catteau G, Thomas F, Descamps D. Four-year follow-up of the immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine when administered to adolescent girls aged 10-14 years. J Adolesc Health 2012; 50: 187-94; PMID:22265115; http://dx.doi.org/10.1016/j.jadohealth.2011.11.004
  • Naud PS, Roteli-Martins CM, De Carvalho NS, Teixeira JC, de Borba PC, Sanchez N, Zahaf T, Catteau G, Geeraerts B, Descamps D. Sustained efficacy, immunogenicity, and safety of the HPV-16/18 AS04-adjuvanted vaccine : final analysis of a long-term follow-up study up to 9.4 years post-vaccination. Hum Vaccin Immunother 2014; 10: 2147-62; PMID:25424918; http://dx.doi.org/10.4161/hv.29532
  • Giannini SL, Hanon E, Moris P, Van Mechelen M, Morel S, Dessy F, Fourneau MA, Colau B, Suzich J, Losonksy G, et al. Enhanced humoral and memory B cellular immunity using HPV16/18 L1 VLP vaccine formulated with the MPL/aluminium salt combination (AS04) compared to aluminium salt only. Vaccine 2006; 24: 5937-49; PMID:16828940; http://dx.doi.org/10.1016/j.vaccine.2006.06.005
  • Puthanakit T, Huang L, Tang R, Schwarz T, Esposito S, Frenette L, McNeil S, Rheault P, Horn M, Klar M, et al. Non-inferiority of HPV-16/18 AS04-adjuvanted vaccine administered as 2-dose schedules in girls (9-14 years) versus 3 doses in women (15-25 years): a randomised trial. Abstract presented at ESPID 2014. May 6-10, 2014. Dublin, Ireland. Available at: http://espid.meetingxpert.net/espid_945/poster_95279/program.aspx. Accessed 11 December 2014
  • Puthanakit T, Schwarz T, Esposito S, Frenette L, McNeil S, Rheault P, Horn M, Poncelet S, Suryakiran P, Hezareh M, 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 presented at EUROGIN 2013. November 3-6, 2013. Florence, Italy. Available at: http://www.eurogin.com/2013/images/pdf/EUROGIN-2013-Abstracts-Part-2.pdf. Accessed 11 December 2014
  • Schwarz TF, Spaczynski M, Schneider A, Wysocki J, Galaj A, Perona P, Poncelet S, Zahaf T, Hardt K, Descamps D, et al. Immunogenicity and tolerability of an HPV-16/18 AS04-adjuvanted prophylactic cervical cancer vaccine in women aged 15-55 years. Vaccine 2009; 27: 581-7; PMID:19022320; http://dx.doi.org/10.1016/j.vaccine.2008.10.088
  • David MP, Van Herck K, Hardt K, Tibaldi F, Dubin G, Descamps D, Van Damme P. 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: S1-S6; PMID:19217149; http://dx.doi.org/10.1016/j.ygyno.2009.01.011
  • Fraser C, Tomassini JE, Xi L, Golm G, Watson M, Giuliano AR, Barr E, Ault KA. Modeling the long-term antibody response of a human papillomavirus (HPV) virus-like particle (VLP) type 16 prophylactic vaccine. Vaccine 2007; 25: 4324-33; PMID:17445955; http://dx.doi.org/10.1016/j.vaccine.2007.02.069
  • Kreimer AR, Rodriguez AC, Hildesheim A, Herrero R, Porras C, Schiffman M, Gonzalez P, Solomon D, Jimenez S, Schiller JT, 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: 1444-51; PMID:21908768; http://dx.doi.org/10.1093/jnci/djr319
  • Safaeian M, Porras C, Pan Y, Kreimer A, Schiller JT, Gonzalez P, Lowy DR, Wacholder S, Schiffman M, Rodriguez AC, et al. Durable antibody responses following one dose of the bivalent human papillomavirus L1 virus-like particle vaccine in the Costa Rica Vaccine Trial. Cancer Prev Res (Phila) 2013; 6: 1242-50; PMID:24189371; http://dx.doi.org/10.1158/1940-6207.CAPR-13-0203
  • Dessy FJ, Giannini SL, Bougelet CA, Kemp TJ, David MP, Poncelet SM, Pinto LA, Wettendorff MA. Correlation between direct ELISA, single epitope-based inhibition ELISA and pseudovirion-based neutralization assay for measuring anti-HPV-16 and anti-HPV-18 antibody response after vaccination with the AS04-adjuvanted HPV-16/18 cervical cancer vaccine. Hum Vaccin 2008; 4: 425-34; PMID:18948732; http://dx.doi.org/10.4161/hv.4.6.6912
  • Einstein MH, Baron M, Levin MJ, Chatterjee A, Edwards RP, Zepp F, Carletti I, Dessy FJ, Trofa AF, Schuind A, et al. Comparison of the immunogenicity and safety of CervarixTM and Gardasil® human papillomavirus (HPV) cervical cancer vaccines in healthy women aged 18-45 years. Hum Vaccin 2009; 5: 705-19; PMID:19684472; http://dx.doi.org/10.4161/hv.5.10.9518
  • Pan W. Akaike's information criterion in generalized estimating equations. Biometrics 2001; 57: 120-5; PMID:11252586; http://dx.doi.org/10.1111/j.0006-341X.2001.00120.x