Sustained efficacy, immunogenicity, and safety of the HPV-16/18 AS04-adjuvanted vaccine

References

• Walboomers JM, Jacobs MV, Manos MM, Bosch FX, Kummer JA, Shah KV, Snijders PJF, Peto J, Meijer CJLM, Muñoz N. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol 1999; 189:12 - 9; http://dx.doi.org/10.1002/(SICI)1096-9896(199909)189:1<12::AID-PATH431>3.0.CO;2-F; PMID: 10451482
   PubMed Web of Science ®Google Scholar
• Bosch FX, Lorincz A, Muñoz N, Meijer CJLM, Shah KV. The causal relation between human papillomavirus and cervical cancer. J Clin Pathol 2002; 55:244 - 65; http://dx.doi.org/10.1136/jcp.55.4.244; PMID: 11919208
   PubMed Web of Science ®Google Scholar
• Muñoz N, Bosch FX, de Sanjosé S, Herrero R, Castellsagué X, Shah KV, Snijders PJ, Meijer CJLM, International Agency for Research on Cancer Multicenter Cervical Cancer Study Group. Epidemiologic classification of human papillomavirus types associated with cervical cancer. N Engl J Med 2003; 348:518 - 27; http://dx.doi.org/10.1056/NEJMoa021641; PMID: 12571259
   PubMed Web of Science ®Google Scholar
• Schiffman M, Clifford G, Buonaguro FM. Classification of weakly carcinogenic human papillomavirus types: addressing the limits of epidemiology at the borderline. Infect Agent Cancer 2009; 4:8; http://dx.doi.org/10.1186/1750-9378-4-8; PMID: 19486508
   PubMedGoogle Scholar
• de Sanjose S, Quint WGV, Alemany L, Geraets DT, Klaustermeier JE, Lloveras B, Tous S, Felix A, Bravo LE, Shin H-R, et al, Retrospective International Survey and HPV Time Trends Study Group. Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. Lancet Oncol 2010; 11:1048 - 56; http://dx.doi.org/10.1016/S1470-2045(10)70230-8; PMID: 20952254
   PubMed Web of Science ®Google Scholar
• Wheeler CM, Castellsagué X, Garland SM, Szarewski A, Paavonen J, Naud P, Salmerón J, Chow S-N, Apter D, Kitchener H, et al, HPV PATRICIA Study Group. 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; http://dx.doi.org/10.1016/S1470-2045(11)70287-X; PMID: 22075170
   PubMed Web of Science ®Google Scholar
• Castellsagué X, Schneider A, Kaufmann AM, Bosch FX. HPV vaccination against cervical cancer in women above 25 years of age: key considerations and current perspectives. Gynecol Oncol 2009; 115:Suppl S15 - 23; http://dx.doi.org/10.1016/j.ygyno.2009.09.021; PMID: 19819540
   PubMed Web of Science ®Google Scholar
• Roteli-Martins CM, Naud P, De Borba P, Teixeira JC, De Carvalho NS, Zahaf T, Sanchez N, Geeraerts B, Descamps D. Sustained immunogenicity and efficacy of the HPV-16/18 AS04-adjuvanted vaccine: up to 8.4 years of follow-up. Hum Vaccin Immunother 2012; 8:390 - 7; http://dx.doi.org/10.4161/hv.18865; PMID: 22327492
   PubMed Web of Science ®Google Scholar
• Rowhani-Rahbar A, Alvarez FB, Bryan JT, Hughes JP, Hawes SE, Weiss NS, Koutsky LA. Evidence of immune memory 8.5 years following administration of a prophylactic human papillomavirus type 16 vaccine. J Clin Virol 2012; 53:239 - 43; http://dx.doi.org/10.1016/j.jcv.2011.12.009; PMID: 22209292
   PubMed Web of Science ®Google Scholar
• 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; http://dx.doi.org/10.1016/j.vaccine.2006.06.005; PMID: 16828940
   PubMed Web of Science ®Google Scholar
• De Carvalho N, Teixeira J, Roteli-Martins CM, Naud P, De Borba P, Zahaf T, Sanchez N, Schuind A. Sustained efficacy and immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine up to 7.3 years in young adult women. Vaccine 2010; 28:6247 - 55; http://dx.doi.org/10.1016/j.vaccine.2010.07.007; PMID: 20643092
   PubMed Web of Science ®Google Scholar
• Moscicki AB, Wheeler CM, Romanowski B, Hedrick J, Gall S, Ferris D, Poncelet S, Zahaf T, Moris P, Geeraerts B, et al. Immune responses elicited by a fourth dose of the HPV-16/18 AS04-adjuvanted vaccine in previously vaccinated adult women. Vaccine 2012; 31:234 - 41; http://dx.doi.org/10.1016/j.vaccine.2012.09.037; PMID: 23063422
   PubMed Web of Science ®Google Scholar
• Petäjä 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; http://dx.doi.org/10.1002/ijc.25887; PMID: 21190190
   PubMed Web of Science ®Google Scholar
• Schwarz TF, Spaczynski M, Schneider A, Wysocki J, Galaj A, Schulze K, Poncelet SM, Catteau G, Thomas F, Descamps D. Persistence of immune response to HPV-16/18 AS04-adjuvanted cervical cancer vaccine in women aged 15-55 years. Hum Vaccin 2011; 7:958 - 65; http://dx.doi.org/10.4161/hv.7.9.15999; PMID: 21892005
   PubMed Web of Science ®Google Scholar
• Schwarz TF, Huang L-M, Medina DMR, Valencia A, Lin T-Y, Behre U, Catteau G, Thomas F, Descamps Dl. 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 Adol Hlth 2012; 50:187 - 94; http://dx.doi.org/10.1016/j.jadohealth.2011.11.004
   PubMed Web of Science ®Google Scholar
• Paavonen J, Jenkins D, Bosch FX, Naud P, Salmerón J, Wheeler CM, Chow S-N, Apter DL, Kitchener HC, Castellsague X, et al, HPV PATRICIA study group. 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; http://dx.doi.org/10.1016/S0140-6736(07)60946-5; PMID: 17602732
   PubMed Web of Science ®Google Scholar
• Paavonen J, Naud P, Salmerón J, Wheeler CM, Chow S-N, Apter D, Kitchener H, Castellsague X, Teixeira JC, Skinner SR, et al, HPV PATRICIA Study Group. 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; http://dx.doi.org/10.1016/S0140-6736(09)61248-4; PMID: 19586656
   PubMed Web of Science ®Google Scholar
• Lehtinen M, Paavonen J, Wheeler CM, Jaisamrarn U, Garland SM, Castellsagué X, Skinner SR, Apter D, Naud P, Salmerón J, et al, HPV PATRICIA Study Group. 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; http://dx.doi.org/10.1016/S1470-2045(11)70286-8; PMID: 22075171
   PubMed Web of Science ®Google Scholar
• Verstraeten T, Descamps D, David M-P, 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; http://dx.doi.org/10.1016/j.vaccine.2008.09.049; PMID: 18845199
   PubMed Web of Science ®Google Scholar
• 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; http://dx.doi.org/10.4161/hv.5.5.7211; PMID: 19221517
   PubMed Web of Science ®Google Scholar
• Harper DM, Franco EL, Wheeler C, Ferris DG, Jenkins D, Schuind A, Zahaf T, Innis B, Naud P, De Carvalho NS, et al, GlaxoSmithKline HPV Vaccine Study Group. 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; http://dx.doi.org/10.1016/S0140-6736(04)17398-4; PMID: 15541448
   PubMed Web of Science ®Google Scholar
• Harper DM, Franco EL, Wheeler CM, Moscicki A-B, Romanowski B, Roteli-Martins CM, Jenkins D, Schuind A, Costa Clemens SA, Dubin G, HPV Vaccine Study group. 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; http://dx.doi.org/10.1016/S0140-6736(06)68439-0; PMID: 16631880
   PubMed Web of Science ®Google Scholar
• The GlaxoSmithKline Vaccine HPV-007 Study Group. Sustained efficacy and immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine: analysis of a randomised placebo-controlled trial up to 6·4 years. Lancet 2009; 374:1975 - 85; http://dx.doi.org/10.1016/S0140-6736(09)61567-1; PMID: 19962185
   PubMed Web of Science ®Google Scholar
• Einstein MH, Baron M, Levin MJ, Chatterjee A, Edwards RP, Zepp F, Carletti I, Dessy FJ, Trofa AF, Schuind A, et al, HPV-010 Study Group. 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; 5:705 - 19; http://dx.doi.org/10.4161/hv.5.10.9518; PMID: 19684472
   PubMed Web of Science ®Google Scholar
• Dessy FJ, Giannini SL, Bougelet CA, Kemp TJ, David M-PM, 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; http://dx.doi.org/10.4161/hv.4.6.6912; PMID: 18948732
   PubMed Web of Science ®Google Scholar
• 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:Suppl S1 - 6; http://dx.doi.org/10.1016/j.ygyno.2009.01.011; PMID: 19217149
   PubMed Web of Science ®Google Scholar
• 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; http://dx.doi.org/10.1016/j.vaccine.2007.02.069; PMID: 17445955
   PubMed Web of Science ®Google Scholar
• Herrero R, Wacholder S, Rodríguez AC, Solomon D, González P, Kreimer AR, Porras C, Schussler J, Jiménez S, Sherman ME, et al, Costa Rica Vaccine Trial Group. Prevention of persistent human papillomavirus infection by an HPV16/18 vaccine: a community-based randomized clinical trial in Guanacaste, Costa Rica. Cancer Discov 2011; 1:408 - 19; http://dx.doi.org/10.1158/2159-8290.CD-11-0131; PMID: 22586631
   PubMed Web of Science ®Google Scholar
• Kreimer AR, Rodriguez AC, Hildesheim A, Herrero R, Porras C, Schiffman M, González P, Solomon D, Jiménez S, Schiller JT, et al, CVT Vaccine Group. Proof-of-principle evaluation of the efficacy of fewer than three doses of a bivalent HPV16/18 vaccine. J Natl Cancer Inst 2011; a 103:1444 - 51; http://dx.doi.org/10.1093/jnci/djr319; PMID: 21908768
   PubMed Web of Science ®Google Scholar
• Angelo M-G, David M-P, 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; a 23:466 - 79; http://dx.doi.org/10.1002/pds.3554; PMID: 24644063
   PubMed Web of Science ®Google Scholar
• Angelo M-G, Zima J, Tavares Da Silva F, Baril L, Arellano F. Post-licensure safety surveillance for human papillomavirus-16/18-AS04-adjuvanted vaccine: more than 4 years of experience. Pharmacoepidemiol Drug Saf 2014; b 23:456 - 65; http://dx.doi.org/10.1002/pds.3593; PMID: 24644078
   PubMed Web of Science ®Google Scholar
• Wacholder S, Chen BE, Wilcox A, Macones G, Gonzalez P, Befano B, Hildesheim A, Rodríguez AC, Solomon D, Herrero R, et al, CVT group. Risk of miscarriage with bivalent vaccine against human papillomavirus (HPV) types 16 and 18: pooled analysis of two randomised controlled trials. BMJ 2010; 340:c712; http://dx.doi.org/10.1136/bmj.c712; PMID: 20197322
   PubMed Web of Science ®Google Scholar
• van Doorn LJ, Molijn A, Kleter B, Quint W, Colau B. Highly effective detection of human papillomavirus 16 and 18 DNA by a testing algorithm combining broad-spectrum and type-specific PCR. J Clin Microbiol 2006; 44:3292 - 8; http://dx.doi.org/10.1128/JCM.00539-06; PMID: 16954263
   PubMed Web of Science ®Google Scholar
• Pastrana DV, Buck CB, Pang Y-YS, Thompson CD, Castle PE, FitzGerald PC, Krüger Kjaer S, Lowy DR, Schiller JT. Reactivity of human sera in a sensitive, high-throughput pseudovirus-based papillomavirus neutralization assay for HPV16 and HPV18. Virology 2004; 321:205 - 16; http://dx.doi.org/10.1016/j.virol.2003.12.027; PMID: 15051381
   PubMed Web of Science ®Google Scholar