Lot-to-lot consistency study of an Escherichia coli-produced bivalent human papillomavirus vaccine in adult women: a randomized trial

References

• Plummer M, de Martel C, Vignat J, Ferlay J, Bray F, Franceschi S. Global burden of cancers attributable to infections in 2012: a synthetic analysis. Lancet Glob Health. 2016;4:e609–e616. doi:10.1016/s2214-109x(16)30143-7. PMID: 27470177.
   PubMed Web of Science ®Google Scholar
• Serrano B, Brotons M, Bosch FX, Bruni L. Epidemiology and burden of HPV-related disease. Best Pract Res Clin Obstet Gynaecol. 2018;47:14–26. doi:10.1016/j.bpobgyn.2017.08.006. PMID: 29037457.
   PubMed Web of Science ®Google Scholar
• de Martel C, Plummer M, Vignat J, Franceschi S. Worldwide burden of cancer attributable to HPV by site, country and HPV type. Int J Cancer. 2017;141:664–70. doi:10.1002/ijc.30716. PMID: 28369882.
   PubMed Web of Science ®Google Scholar
• Drolet M, Benard E, Boily MC, Ali H, Baandrup L, Bauer H, Beddows S, Brisson J, Brotherton JML, Cummings T, et al. Population-level impact and herd effects following human papillomavirus vaccination programmes: a systematic review and meta-analysis. Lancet Infect Dis. 2015;15:565–80. doi:10.1016/s1473-3099(14)71073-4. PMID: 25744474.
   PubMed Web of Science ®Google Scholar
• Castle PE, Maza M. Prophylactic HPV vaccination: past, present, and future. Epidemiol Infect. 2016;144:449–68. doi:10.1017/s0950268815002198. PMID: 26429676.
   PubMed Web of Science ®Google Scholar
• Mesher D, Panwar K, Thomas SL, Edmundson C, Choi YH, Beddows S, Soldan K. The impact of the national HPV vaccination program in England using the bivalent HPV vaccine: surveillance of type-specific HPV in young females, 2010–2016. J Infect Dis. 2018;218:911–21. doi:10.1093/infdis/jiy249. PMID: 29917082.
   PubMed Web of Science ®Google Scholar
• Drolet M, Benard E, Perez N, Brisson M; Group HPVVIS. Population-level impact and herd effects following the introduction of human papillomavirus vaccination programmes: updated systematic review and meta-analysis. Lancet. 2019;394:497–509. doi:10.1016/S0140-6736(19)30298-3. PMID: 31255301.
   PubMed Web of Science ®Google Scholar
• Clendinen C, Zhang Y, Warburton RN, Light DW. Manufacturing costs of HPV vaccines for developing countries. Vaccine. 2016;34:5984–89. doi:10.1016/j.vaccine.2016.09.042. PMID: 27771183.
   PubMed Web of Science ®Google Scholar
• Hu YM, Huang SJ, Chu K, Wu T, Wang ZZ, Yang CL, Cai J-P, Jiang H-M, Wang Y-J, Guo M, et al. Safety of an Escherichia coli-expressed bivalent human papillomavirus (types 16 and 18) L1 virus-like particle vaccine: an open-label phase I clinical trial. Hum Vaccin Immunother. 2014;10:469–75. doi:10.4161/hv.26846. PMID: 24161937.
   PubMed Web of Science ®Google Scholar
• Wu T, Hu YM, Li J, Chu K, Huang SJ, Zhao H, Wang ZZ, Yang CL, Jiang HM, Wang YJ, et al. Immunogenicity and safety of an E. coli-produced bivalent human papillomavirus (type 16 and 18) vaccine: A randomized controlled phase 2 clinical trial. Vaccine. 2015;33:3940–46. doi:10.1016/j.vaccine.2015.06.052. PMID: 26100924.
   PubMed Web of Science ®Google Scholar
• Qiao YL, Wu T, Li RC, Hu YM, Wei LH, Li CG, Chen W, Huang SJ, Zhao FH, Li MQ, et al. Efficacy, safety, and immunogenicity of an Escherichia coli-produced bivalent human papillomavirus vaccine: an interim analysis of a randomized clinical trial. J Natl Cancer Inst. 2019. doi:10.1093/jnci/djz074. PMID: 31086947.
   PubMedGoogle Scholar
• Hu Y, Guo M, Li C, Chu K, He W, Zhang J, Gu J, Li J, Zhao H, Wu X, et al. Immunogenicity noninferiority study of 2 doses and 3 doses of an Escherichia coli-produced HPV bivalent vaccine in girls vs. 3 doses in young women. Sci China Life Sci. 2019. doi:10.1007/s11427-019-9547-7. PMID: 31231780.
   Web of Science ®Google Scholar
• World Health Organization. Human papillomavirus vaccines: WHO position paper, May 2017. Wkly Epidemiol Rec. 2017; 92:241–68.
   PubMedGoogle Scholar
• 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. doi:10.1542/peds.2006-0461. PMID: 17079588.
   PubMed Web of Science ®Google Scholar
• 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. doi:10.1016/j.jadohealth.2007.02.015. PMID: 17531764.
   PubMed Web of Science ®Google Scholar
• Van Damme P, Olsson SE, Block S, Castellsague X, Gray GE, Herrera T, Huang L-M, Kim DS, Pitisuttithum P, Chen J, et al. Immunogenicity and safety of a 9-valent HPV vaccine. Pediatrics. 2015;136:e28–e39. doi:10.1542/peds.2014-3745. PMID: 26101366.
   PubMed Web of Science ®Google Scholar
• Dobson SR, McNeil S, Dionne M, Dawar M, Ogilvie G, Krajden M, Sauvageau C, Scheifele DW, Kollmann TR, Halperin SA, et al. Immunogenicity of 2 doses of HPV vaccine in younger adolescents vs 3 doses in young women: a randomized clinical trial. JAMA. 2013;309:1793–802. doi:10.1001/jama.2013.1625. PMID: 23632723.
   PubMed Web of Science ®Google Scholar
• Schiller JT, Lowy DR. Understanding and learning from the success of prophylactic human papillomavirus vaccines. Nat Rev Microbiol. 2012;10:681–92. doi:10.1038/nrmicro2872. PMID: 22961341.
   PubMed Web of Science ®Google Scholar
• Ferguson M, Wilkinson DE, Zhou T. WHO meeting on the standardization of HPV assays and the role of the WHO HPV laboratory network in supporting vaccine introduction held on 24–25 January 2008, Geneva, Switzerland. Vaccine. 2009;27:337–47. doi:10.1016/j.vaccine.2008.10.062. PMID: 19007840.
   PubMed Web of Science ®Google Scholar
• Zhao H, Lin ZJ, Huang SJ, Li J, Liu XH, Guo M, Zhang J, Xia N-S, Pan H-R, Wu T, et al. Correlation between ELISA and pseudovirion-based neutralisation assay for detecting antibodies against human papillomavirus acquired by natural infection or by vaccination. Hum Vaccin Immunother. 2014;10:740–46. doi:10.4161/hv.27619. PMID: 24384608.
   PubMed Web of Science ®Google Scholar
• Gu Y, Wei M, Wang D, Li Z, Xie M, Pan H, Wu T, Zhang J, Li S, Xia N, et al. Characterization of an Escherichia coli-derived human papillomavirus type 16 and 18 bivalent vaccine. Vaccine. 2017;35:4637–45. doi:10.1016/j.vaccine.2017.06.084. PMID: 28736197.
   PubMed Web of Science ®Google Scholar
• Pastrana DV, Buck CB, Pang YY, 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. doi:10.1016/j.virol.2003.12.027. PMID: 15051381.
   PubMed Web of Science ®Google Scholar
• Zhu FC, Chen W, Hu YM, Hong Y, Li J, Zhang X, Zhang Y-J, Pan Q-J, Zhao F-H, Yu J-X, et al. Efficacy, immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in healthy Chinese women aged 18–25 years: results from a randomized controlled trial. Int J Cancer. 2014;135:2612–22. doi:10.1002/ijc.28897. PMID: 24740596.
   PubMed Web of Science ®Google Scholar
• Zhu FC, Hu SY, Hong Y, Hu YM, Zhang X, Zhang YJ, Pan Q-J, Zhang W-H, Zhao F-H, Zhang C-F, et al. Efficacy, immunogenicity, and safety of the HPV-16/18 AS04-adjuvanted vaccine in Chinese women aged 18–25 years: event-triggered analysis of a randomized controlled trial. Cancer Med. 2017;6:12–25. doi:10.1002/cam4.869. PMID: 27998015.
   PubMed Web of Science ®Google Scholar
• Schiller JT, Castellsague X, Garland SM. A review of clinical trials of human papillomavirus prophylactic vaccines. Vaccine. 2012;30(Suppl 5):F123–F138. doi:10.1016/j.vaccine.2012.04.108. PMID: 23199956.
   PubMed Web of Science ®Google Scholar
• Ault KA. 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;369:1861–68. doi:10.1016/s0140-6736(07)60852-6.
   PubMed Web of Science ®Google Scholar
• Paavonen J, Naud P, Salmeron J, Wheeler CM, Chow SN, Apter D, Kitchener H, Castellsague 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. doi:10.1016/S0140-6736(09)61248-4. PMID: 19586656.
   PubMed Web of Science ®Google Scholar
• Chen W, Zhao Y, Xie X, Liu J, Li J, Zhao C, Wang S, Liao X, Shou Q, Zheng M, et al. Safety of a quadrivalent human papillomavirus vaccine in a Phase 3, randomized, double-blind, placebo-controlled clinical trial among Chinese women during 90months of follow-up. Vaccine. 2019;37:889–97. doi:10.1016/j.vaccine.2018.12.030. PMID: 30638797.
   PubMed Web of Science ®Google Scholar