450
Views
42
CrossRef citations to date
0
Altmetric
Review

Recombinant human papillomavirus nonavalent vaccine in the prevention of cancers caused by human papillomavirus

, , , , &
Pages 1951-1967 | Published online: 04 Jul 2019

References

  • Brotherton JML, Tabrizi SN, Phillips S, et al. Looking beyond human papillomavirus (HPV) genotype 16 and 18: defining HPV genotype distribution in cervical cancers in Australia prior to vaccination. Int J Cancer. 2017;141(8):1576–1584. doi:10.1002/ijc.3087128677147
  • Chesson HW, Dunne EF, Hariri S, Markowitz LE. The estimated lifetime probability of acquiring human papillomavirus in the United States. Sex Transm Dis. 2014;41(11):660–664. doi:10.1097/OLQ.000000000000019325299412
  • Bruni L, Diaz M, Castellsague X, Ferrer E, Bosch FX, de Sanjose S. Cervical human papillomavirus prevalence in 5 continents: meta-analysis of 1 million women with normal cytological findings. J Infect Dis. 2010;202(12):1789–1799. doi:10.1086/65732121067372
  • Molano M, Van den Brule A, Plummer M, et al. Determinants of clearance of human papillomavirus infections in Colombian women with normal cytology: a population-based, 5-year follow-up study. Am J Epidemiol. 2003;158(5):486–494. doi:10.1093/aje/kwg17112936904
  • Garland SM, Steben M, Sings HL, et al. Natural history of genital warts: analysis of the placebo arm of 2 randomized phase III trials of a quadrivalent human papillomavirus (types 6, 11, 16, and 18) vaccine. J Infect Dis. 2009;199(6):805–814. doi:10.1086/59707119199546
  • Patel H, Wagner M, Singhal P, Kothari S. Systematic review of the incidence and prevalence of genital warts. BMC Infect Dis. 2013;13:39. doi:10.1186/1471-2334-13-3923347441
  • Larson DA, Derkay CS. Epidemiology of recurrent respiratory papillomatosis. APMIS. 2010;118(6–7):450–454. doi:10.1111/j.1600-0463.2010.02619.x20553527
  • 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(4):664–670. doi:10.1002/ijc.3071628369882
  • de Sanjose S, Quint WG, Alemany L, et al. Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. Lancet Oncol. 2010;11(11):1048–1056. doi:10.1016/S1470-2045(10)70230-820952254
  • D’Souza G, Kreimer AR, Viscidi R, et al. Case-control study of human papillomavirus and oropharyngeal cancer. N Engl J Med. 2007;356(19):1944–1956. doi:10.1056/NEJMoa06549717494927
  • Marur S, D’Souza G, Westra WH, Forastiere AA. HPV-associated head and neck cancer: a virus-related cancer epidemic. Lancet Oncol. 2010;11(8):781–789. doi:10.1016/S1470-2045(10)70017-620451455
  • Frisch M, Biggar RJ, Goedert JJ. Human papillomavirus-associated cancers in patients with human immunodeficiency virus infection and acquired immunodeficiency syndrome. J Natl Cancer Inst. 2000;92(18):1500–1510. doi:10.1093/jnci/92.18.150010995805
  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018. doi:10.3322/caac.21492
  • Toh ZQ, Licciardi PV, Russell FM, Garland SM, Batmunkh T, Mulholland EK. Cervical cancer prevention through HPV vaccination in low- and middle-income countries in Asia. Asian Pac J Cancer Prev. 2017;18(9):2339–2343. doi:10.22034/APJCP.2017.18.9.233928950675
  • Howard N, Gallagher KE, Mounier-Jack S, et al. What works for human papillomavirus vaccine introduction in low and middle-income countries? Papillomavirus Res. 2017;4:22–25. doi:10.1016/j.pvr.2017.06.00329179865
  • Bruni L, Barrionuevo-Rosas L, Albero GAM, et al. Human papillomavirus and related diseases in Asia. Summary report. ICO Information Centre on HPV and Cancer (HPV Information Centre); 2018 Accessed 417, 2015.
  • Garcon N, Wettendorff M, Van Mechelen M. Role of AS04 in human papillomavirus vaccine: mode of action and clinical profile. Expert Opin Biol Ther. 2011;11(5):667–677. doi:10.1517/14712598.2011.57362421457083
  • Einstein MH, Baron M, Levin MJ, et al. 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(10):705–719. doi:10.4161/hv.5.10.951819684472
  • Einstein MH, Levin MJ, Chatterjee A, et al. Comparative humoral and cellular immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine in healthy women aged 18-45 years: follow-up through Month 48 in a Phase III randomized study. Hum Vaccin Immunother. 2014;10(12):3455–3465. doi:10.4161/hv.3611725483700
  • Future II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med. 2007;356(19):1915–1927. doi:10.1056/NEJMoa06174117494925
  • Garland SM, Hernandez-Avila M, Wheeler CM, et al. Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases. N Engl J Med. 2007;356(19):1928–1943. doi:10.1056/NEJMoa06176017494926
  • Dillner J, Kjaer SK, Future I/II Study Group, et al. Four year efficacy of prophylactic human papillomavirus quadrivalent vaccine against low grade cervical, vulvar, and vaginal intraepithelial neoplasia and anogenital warts: randomised controlled trial. BMJ. 341;2010:c3493. doi:10.1136/bmj.c349320647284
  • Lehtinen M, Paavonen J, Wheeler CM, 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(1):89–99. doi:10.1016/S1470-2045(11)70286-822075171
  • Mensah FA, Mehta MR, Lewis JS Jr., Lockhart AC. The human papillomavirus vaccine: current perspective and future role in prevention and treatment of anal intraepithelial neoplasia and anal cancer. Oncologist. 2016;21(4):453–460. doi:10.1634/theoncologist.2015-007526961923
  • Harper DM, DeMars LR. HPV vaccines - A review of the first decade. Gynecol Oncol. 2017;146(1):196–204. doi:10.1016/j.ygyno.2017.04.00428442134
  • Schwarz TF, Galaj A, Spaczynski M, et al. Ten-year immune persistence and safety of the HPV-16/18 AS04-adjuvanted vaccine in females vaccinated at 15-55 years of age. Cancer Med. 2017;6(11):2723–2731. doi:10.1002/cam4.115528984053
  • Schiller J, Lowy D. Explanations for the high potency of HPV prophylactic vaccines. Vaccine. 2018;36(32Pt A):4768–4773. doi:10.1016/j.vaccine.2017.12.07929325819
  • Block SL, Nolan T, Sattler C, 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(5):2135–2145. doi:10.1542/peds.2006-046117079588
  • Pedersen C, Petaja T, Strauss G, 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(6):564–571. doi:10.1016/j.jadohealth.2007.02.01517531764
  • Petaja T, Keranen H, Karppa T, et al. Immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in healthy boys aged 10-18 years. J Adolesc Health. 2009;44(1):33–40. doi:10.1016/j.jadohealth.2008.10.00219101456
  • Toh ZQ, Licciardi PV, Fong J, et al. Reduced dose human papillomavirus vaccination: an update of the current state-of-the-art. Vaccine. 2015;33(39):5042–5050. doi:10.1016/j.vaccine.2015.07.10226271829
  • World Health Organization. Meeting of the Strategic Advisory Group Of Experts on immunization, April 2014 – conclusions and recommendations. Relevé Épidémiologique Hebdomadaire. 2014;89(21):221–236.24864348
  • Brown DR, Kjaer SK, Sigurdsson K, et al. The impact of quadrivalent human papillomavirus (HPV; types 6, 11, 16, and 18) L1 virus-like particle vaccine on infection and disease due to oncogenic nonvaccine HPV types in generally HPV-naive women aged 16-26 years. J Infect Dis. 2009;199(7):926–935. doi:10.1086/59730719236279
  • Wheeler CM, Kjaer SK, Sigurdsson K, et al. The impact of quadrivalent human papillomavirus (HPV; types 6, 11, 16, and 18) L1 virus-like particle vaccine on infection and disease due to oncogenic nonvaccine HPV types in sexually active women aged 16-26 years. J Infect Dis. 2009;199(7):936–944. doi:10.1086/59730919236277
  • Paavonen J, Naud P, Salmeron J, 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(9686):301–314. doi:10.1016/S0140-6736(09)61248-419586656
  • Kavanagh K, Pollock KG, Cuschieri K, et al. Changes in the prevalence of human papillomavirus following a national bivalent human papillomavirus vaccination programme in Scotland: a 7-year cross-sectional study. Lancet Infect Dis. 2017;17(12):1293–1302. doi:10.1016/S1473-3099(17)30468-128965955
  • Barzon L, Squarzon L, Masiero S, et al. Neutralizing and cross-neutralizing antibody titres induced by bivalent and quadrivalent human papillomavirus vaccines in the target population of organized vaccination programmes. Vaccine. 2014;32(41):5357–5362. doi:10.1016/j.vaccine.2014.07.01425045814
  • Garland SM, Cornall AM, Brotherton JML, et al. Final analysis of a study assessing genital human papillomavirus genoprevalence in young Australian women, following eight years of a national vaccination program. Vaccine. 2018;36(23):3221–3230. doi:10.1016/j.vaccine.2018.04.08029724506
  • Einstein MH, Baron M, Levin MJ, et al. Comparison of the immunogenicity of the human papillomavirus (HPV)-16/18 vaccine and the HPV-6/11/16/18 vaccine for oncogenic non-vaccine types HPV-31 and HPV-45 in healthy women aged 18-45 years. Hum Vaccin. 2011;7(12):1359–1373. doi:10.4161/hv.7.12.1828222048172
  • Godi A, Bissett SL, Miller E, Beddows S. Relationship between humoral immune responses against HPV16, HPV18, HPV31 and HPV45 in 12-15 year old girls receiving Cervarix(R) or Gardasil(R) vaccine. PLoS One. 2015;10(10):e0140926. doi:10.1371/journal.pone.014092626495976
  • Kemp TJ, Hildesheim A, Safaeian M, et al. HPV16/18 L1 VLP vaccine induces cross-neutralizing antibodies that may mediate cross-protection. Vaccine. 2011;29(11):2011–2014. doi:10.1016/j.vaccine.2011.01.00121241731
  • Joura EA, Giuliano AR, Iversen OE, et al. A 9-valent HPV vaccine against infection and intraepithelial neoplasia in women. N Engl J Med. 2015;372(8):711–723. doi:10.1056/NEJMoa140504425693011
  • Huh WK, Joura EA, Giuliano AR, 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(10108):2143–2159. doi:10.1016/S0140-6736(17)31821-428886907
  • Garland SM, Pitisuttithum P, Ngan HYS, et al. Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine: subgroup analysis of participants from Asian countries. J Infect Dis. 2018;218(1):95–108. doi:10.1093/infdis/jiy13329767739
  • Ruiz-Sternberg AM, Moreira ED Jr., Restrepo JA, et al. Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women. Papillomavirus Res. 2018;5:63–74. doi:10.1016/j.pvr.2017.12.00429269325
  • Iwata S, Murata S, Rong Han S, Wakana A, Sawata M, Tanaka Y. Safety and Immunogenicity of a 9-valent human papillomavirus vaccine administered to 9- to 15-year-old Japanese girls. Jpn J Infect Dis. 2017;70(4):368–373. doi:10.7883/yoken.JJID.2016.29928003597
  • Van Damme P, Meijer C, Kieninger D, et al. A phase III clinical study to compare the immunogenicity and safety of the 9-valent and quadrivalent HPV vaccines in men. Vaccine. 2016;34(35):4205–4212. doi:10.1016/j.vaccine.2016.06.05627354258
  • Vesikari T, Brodszki N, van Damme P, et al. A randomized, double-blind, phase III study of the immunogenicity and safety of a 9-valent human papillomavirus L1 virus-like particle vaccine (V503) versus gardasil(R) in 9-15-year-old girls. Pediatr Infect Dis J. 2015;34(9):992–998. doi:10.1097/INF.000000000000077326090572
  • Luxembourg A, Ed M Jr., Samakoses R, et al. Phase III, randomized controlled trial in girls 9-15 years old to evaluate lot consistency of a novel nine-valent human papillomavirus L1 virus-like particle vaccine. Hum Vaccin Immunother. 2015;11(6):1306–1312. doi:10.1080/21645515.2015.100981926086587
  • Van Damme P, Olsson SE, Block S, et al. Immunogenicity and safety of a 9-valent HPV vaccine. Pediatrics. 2015;136(1):e28–39. doi:10.1542/peds.2014-374526101366
  • Luxembourg A, Brown D, Bouchard C, et al. Phase II studies to select the formulation of a multivalent HPV L1 virus-like particle (VLP) vaccine. Hum Vaccin Immunother. 2015;11(6):1313–1322. doi:10.1080/21645515.2015.101201025912208
  • Guevara A, Cabello R, Woelber L, et al. Antibody persistence and evidence of immune memory at 5years following administration of the 9-valent HPV vaccine. Vaccine. 2017;35(37):5050–5057. doi:10.1016/j.vaccine.2017.07.01728789851
  • Castellsague X, Giuliano AR, Goldstone S, et al. Immunogenicity and safety of the 9-valent HPV vaccine in men. Vaccine. 2015;33(48):6892–6901. doi:10.1016/j.vaccine.2015.06.08826144901
  • Garland SM, Cheung TH, McNeill S, et al. Safety and immunogenicity of a 9-valent HPV vaccine in females 12-26 years of age who previously received the quadrivalent HPV vaccine. Vaccine. 2015;33(48):6855–6864. doi:10.1016/j.vaccine.2015.08.05926411885
  • Vatti A, Monsalve DM, Pacheco Y, Chang C, Anaya JM, Gershwin ME. Original antigenic sin: a comprehensive review. J Autoimmun. 2017;83:12–21. doi:10.1016/j.jaut.2017.04.00828479213
  • Van Damme P, Bonanni P, Bosch FX, et al. Use of the nonavalent HPV vaccine in individuals previously fully or partially vaccinated with bivalent or quadrivalent HPV vaccines. Vaccine. 2016;34(6):757–761. doi:10.1016/j.vaccine.2015.12.06326772631
  • Iversen OE, Miranda MJ, Ulied A, et al. Immunogenicity of the 9-valent HPV vaccine using 2-dose regimens in girls and boys vs a 3-dose regimen in women. JAMA. 2016;316(22):2411–2421. doi:10.1001/jama.2016.1761527893068
  • Meites E, Kempe A, Markowitz L. se of a 2-dose schedule for Human Papillomavirus Vaccination — updated Recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep. 2016;65:1405–1408. doi:10.15585/mmwr.mm6549a527977643
  • European Medicines Agency Gardasil 9. Summary of product characteristics; 2018 Accessed 1029, 2018.
  • National Centre For Immunisation Research and Surveillance. Human papillomavirus (HPV) vaccines for Australians: information for immunisation providers; 2018 Accessed 1029, 2018.
  • Moreira ED Jr., Block SL, Ferris D, et al. Safety profile of the 9-Valent HPV vaccine: a combined analysis of 7 phase iii clinical trials. Pediatrics. 2016;138(2):e20154387. doi:10.1542/peds.2015-438727422279
  • Kosalaraksa P, Mehlsen J, Vesikari T, et al. An open-label, randomized study of a 9-valent human papillomavirus vaccine given concomitantly with diphtheria, tetanus, pertussis and poliomyelitis vaccines to healthy adolescents 11-15 years of age. Pediatr Infect Dis J. 2015;34(6):627–634. doi:10.1097/INF.000000000000069425831420
  • Schilling A, Parra MM, Gutierrez M, et al. Coadministration of a 9-valent human papillomavirus vaccine with meningococcal and Tdap vaccines. Pediatrics. 2015;136(3): E563-E572. doi:10.1542/peds.2015-0573
  • Luxembourg A, Kjaer SK, Nygard M, et al. 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.2016.10.00627777126
  • Markowitz LE, Gee J, Chesson H, Stokley S. Ten years of human papillomavirus vaccination in the United States. Acad Pediatr. 2018;18(2S):S3–S10. doi:10.1016/j.acap.2017.09.01429502635
  • Ward K, Quinn H, Menzies R, McIntyre P. A history of adolescent school based vaccination in Australia. Commun Dis Intell Q Rep. 2013;37(2):E168–E174.24168091
  • McClure CA, MacSwain MA, Morrison H, Sanford CJ. Human papillomavirus vaccine uptake in boys and girls in a school-based vaccine delivery program in Prince Edward Island, Canada. Vaccine. 2015;33(15):1786–1790. doi:10.1016/j.vaccine.2015.02.04725731789
  • Brotherton JM, Fridman M, May CL, Chappell G, Saville AM, Gertig DM. Early effect of the HPV vaccination programme on cervical abnormalities in Victoria, Australia: an ecological study. Lancet. 2011;377(9783):2085–2092. doi:10.1016/S0140-6736(11)60551-521684381
  • Machalek DA, Garland SM, Brotherton JML, et al. Very low prevalence of vaccine human papillomavirus (HPV) types among 18 to 35 year old Australian women, nine years following implementation of vaccination. J Infect Dis. 2018. doi:10.1093/infdis/jiy075
  • Tabrizi SN, Brotherton JM, Kaldor JM, et al. Fall in human papillomavirus prevalence following a national vaccination program. J Infect Dis. 2012;206(11):1645–1651. doi:10.1093/infdis/jis59023087430
  • Patel C, Brotherton JM, Pillsbury A, et al. The impact of 10 years of human papillomavirus (HPV) vaccination in Australia: what additional disease burden will a nonavalent vaccine prevent? Euro Surveill. 2018;23:41. doi:10.2807/1560-7917.ES.2018.23.41.1700737
  • Brotherton JM, Hawkes D, Sultana F, et al. Age-specific HPV prevalence among 116,052 women in Australia’s renewed cervical screening program: a new tool for monitoring vaccine impact. Vaccine. 2019;37(3):412–416. doi:10.1016/j.vaccine.2018.11.07530551987
  • Hall MT, Simms KT, Lew JB, et al. The projected timeframe until cervical cancer elimination in Australia: a modelling study. Lancet Public Health. 2018;4(1):E19–E27. doi:10.1016/S2468-2667(18)30183-X
  • Gilca V, Sauvageau C, Trudeau G. Advisory report on the Human Papillomavirus (HPV) Vaccination Schedule. National Institute of Public Health of Quebec; 2018 Available from: https://www.inspq.qc.ca/sites/default/files/publications/2458_papillomavirus_vaccination_schedule.pdf
  • Gilca V, Sauvageau C, Panicker G, De Serres G, Ouakki M, Unger ER. Immunogenicity and safety of a mixed vaccination schedule with one dose of nonavalent and one dose of bivalent HPV vaccine versus two doses of nonavalent vaccine - A randomized clinical trial. Vaccine. 2018;36(46):7017–7024. doi:10.1016/j.vaccine.2018.09.05730314913
  • Toh ZQ, Russell FM, Reyburn R, et al. Sustained antibody responses 6 years following 1, 2, or 3 doses of quadrivalent human papillomavirus (HPV) vaccine in adolescent Fijian girls, and subsequent responses to a single dose of bivalent HPV Vaccine: a prospective cohort study. Clin Infect Dis. 2017;64(7):852–859. doi:10.1093/cid/ciw86528034886
  • Gilca V, Sauvageau C, Boulianne N, et al. The effect of a booster dose of quadrivalent or bivalent HPV vaccine when administered to girls previously vaccinated with two doses of quadrivalent HPV vaccine. Hum Vaccin Immunother. 2015;11(3):732–738. doi:10.1080/21645515.2015.101157025714044
  • Mennini FS, Bonanni P, Bianic F, et al. Cost-effectiveness analysis of the nine-valent HPV vaccine in Italy. Cost Eff Resour Alloc. 2017;15:11. doi:10.1186/s12962-017-0073-828701899
  • Largeron N, Petry KU, Jacob J, Bianic F, Anger D, Uhart M. An estimate of the public health impact and cost-effectiveness of universal vaccination with a 9-valent HPV vaccine in Germany. Expert Rev Pharmacoecon Outcomes Res. 2017;17(1):85–98. doi:10.1080/14737167.2016.120808727366939
  • Durham DP, Ndeffo-Mbah ML, Skrip LA, Jones FK, Bauch CT, Galvani AP. National- and state-level impact and cost-effectiveness of nonavalent HPV vaccination in the United States. Proc Natl Acad Sci U S A. 2016;113(18):5107–5112. doi:10.1073/pnas.151552811327091978
  • Petrosky E, Bocchini JA Jr., Hariri S, et al. Use of 9-valent human papillomavirus (HPV) vaccine: updated HPV vaccination recommendations of the advisory committee on immunization practices. MMWR Morb Mortal Wkly Rep. 2015;64(11):300–304.25811679
  • Bruni L, Diaz M, Barrionuevo-Rosas L, et al. Global estimates of human papillomavirus vaccination coverage by region and income level: a pooled analysis. Lancet Glob Health. 2016;4(7):e453–e463. doi:10.1016/S2214-109X(16)30099-727340003
  • ClinicalTrials.gov. Scientific evaluation of one or two doses of the bivalent or nonavalent prophylactic HPV vaccines; 2018 Accessed 107th, 2018.
  • ClinicalTrials.gov. A dose reduction immunobridging and safety study of two HPV vaccines in tanzanian girls (DoRIS); 2018 Accessed 117th, 2018.
  • The World Health Organization. Vaccine in national immunization programme update; 2018 [Updated 10 2018]. Accessed 1227th, 2018.