References
- Gilbert NL, Gilmour H, Dube E, et al. Estimates and determinants of HPV non-vaccination and vaccine refusal in girls 12 to 14 y of age in Canada: results from the Childhood National Immunization Coverage Survey, 2013. Hum Vaccin Immunother. 2016;12(6):1484–1490. DOI:https://doi.org/10.1080/21645515.2016.1153207
- Gilkey MB, Calo WA, Marciniak MW, et al. Parents who refuse or delay HPV vaccine: differences in vaccination behavior, beliefs, and clinical communication preferences. Hum Vaccin Immunother. 2017;13(3):680–686. DOI:https://doi.org/10.1080/21645515.2016.1247134
- Simms KT, Hanley SJB, Smith MA, et al. Impact of HPV vaccine hesitancy on cervical cancer in Japan: a modelling study. Lancet Public Health. 2020. DOI:https://doi.org/10.1016/s2468-2667(20)30010-4
- Lo Vecchio A, Cambriglia MD, Fedele MC, et al. Determinants of low measles vaccination coverage in children living in an endemic area. Eur J Pediatr. 2019;178(2):243–251. DOI:https://doi.org/10.1007/s00431-018-3289-5
- Quinn SC, Jamison AM, Freimuth VS. Measles outbreaks and public attitudes towards vaccine exemptions: some cautions and strategies for addressing vaccine hesitancy. Hum Vaccin Immunother. 2020;16(5):1050–1054. DOI:https://doi.org/10.1080/21645515.2019.1646578
- Mulligan MJ, Lyke KE, Kitchin N, et al. Phase 1/2 study to describe the safety and immunogenicity of a COVID-19 RNA vaccine candidate (BNT162b1) in adults 18 to 55 years of Age: Interim report. medRxiv Preprint. 2020. DOI:https://doi.org/10.1101/2020.06.30.20142570
- Walsh EE, Frenck R, Falsey AR, et al. RNA-Based COVID-19 vaccine BNT162b2 selected for a pivotal efficacy study. medRxiv Preprint. 2020. DOI:https://doi.org/10.1101/2020.08.17.20176651
- Plotkin SA, Orenstein WA, Offit PA, Edwards KM. Vaccine. 7th ed. Philadelphia, PA: Elsevier; 2018.
- Vetter V, Denizer G, Friedland LR, et al. Understanding modern-day vaccines: what you need to know. Ann Med. 2018;50(2):110–120. DOI:https://doi.org/10.1080/07853890.2017.1407035
- Nakayama T. An inflammatory response is essential for the development of adaptive immunity-immunogenicity and immunotoxicity. Vaccine. 2016;34(47):5815–5818. DOI:https://doi.org/10.1016/j.vaccine.2016.08.051
- Garly M-L, Martins CL, Balé C, et al. BCG scar and positive tuberculin reaction associated with reduced child mortality in West Africa. Vaccine. 2003;21(21-22):2782–2790. DOI:https://doi.org/10.1016/s0264-410x(03)00181-6
- Roth A, Gustafson P, Nhaga A, et al. BCG vaccination scar associated with better childhood survival in Guinea-Bissau. Int J Epidemiol. 2005;34(3):540–547. DOI:https://doi.org/10.1093/ije/dyh392
- Herve C, Laupeze B, Del Giudice G, et al. The how's and what's of vaccine reactogenicity. NPJ Vaccines. 2019;4:39. DOI:https://doi.org/10.1038/s41541-019-0132-6
- Vaccine Safety Committee IoM. Adverse events associated with childhood vaccines: evidence bearing on causality. In: Stratton KR, Howe CJ, Johnston RB, Jr., editors. Adverse events associated with childhood vaccines: evidence bearing on causality. The National academies collection: reports funded by National Institutes of Health. Washington (DC): National Academies Press (US); 1994. p. 059–062.
- Spencer JP, Trondsen Pawlowski RH, Thomas S. Vaccine adverse events: separating myth from reality. Am Fam Physician. 2017;95(12):786–794.
- Chandler RE, Juhlin K, Fransson J, et al. Current safety concerns with human papillomavirus vaccine: a cluster analysis of reports in VigiBase((R)). Drug Saf. 2017;40(1):81–90. DOI:https://doi.org/10.1007/s40264-016-0456-3
- Hasday JD, Garrison A, Singh IS, et al. Febrile-range hyperthermia augments pulmonary neutrophil recruitment and amplifies pulmonary oxygen toxicity. Am J Pathol. 2003;162(6):2005–2017. DOI:https://doi.org/10.1016/s0002-9440(10)64333-7
- Ostberg JR, Patel R, Repasky EA. Regulation of immune activity by mild (fever-range) whole body hyperthermia: effects on epidermal langerhans cells. Cell Stress Chaperones. 2000;5(5):458–461. DOI:https://doi.org/10.1379/1466-1268(2000)005<0458:roiabm>2.0.co;2
- Lin C, Zhang Y, Zhang K, et al. Fever promotes T lymphocyte trafficking via a thermal sensory pathway involving heat shock protein 90 and alpha4 integrins. Immunity. 2019;50(1):137–51e6. DOI:https://doi.org/10.1016/j.immuni.2018.11.013
- Nakayama T. Causal relationship between immunological responses and adverse reactions following vaccination. Vaccine. 2019;37(2):366–371. DOI:https://doi.org/10.1016/j.vaccine.2018.11.045
- Qiao YL, Wu T, Li RC, 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. 2020;112(2):145–153. DOI:https://doi.org/10.1093/jnci/djz074
- Hu Y, Guo M, Li C, 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:https://doi.org/10.1007/s11427-019-9547-7
- Zhu F-C, Zhang J, Zhang X-F, et al. Efficacy and safety of a recombinant hepatitis E vaccine in healthy adults: a large-scale, randomised, double-blind placebo-controlled, phase 3 trial. The Lancet. 2010;376(9744):895–902. DOI:https://doi.org/10.1016/s0140-6736(10)61030-6
- Zhang J, Shih JW, Xia NS. Long-term efficacy of a hepatitis E vaccine. N Engl J Med. 2015;372(23):2265–2266. DOI:https://doi.org/10.1056/NEJMc1504302
- Hu YM, Huang SJ, Chu K, 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(2):469–475. DOI:https://doi.org/10.4161/hv.26846
- Wu T, Hu YM, Li J, 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(32):3940–3946. DOI:https://doi.org/10.1016/j.vaccine.2015.06.052
- Gu Y, Wei M, Wang D, et al. Characterization of an Escherichia coli-derived human papillomavirus type 16 and 18 bivalent vaccine. Vaccine. 2017;35(35 Pt B):4637–4645. DOI:https://doi.org/10.1016/j.vaccine.2017.06.084
- Zhang J, Liu CB, Li RC, et al. Randomized-controlled phase II clinical trial of a bacterially expressed recombinant hepatitis E vaccine. Vaccine. 2009;27(12):1869–1874. DOI:https://doi.org/10.1016/j.vaccine.2008.12.061
- Li SW, Zhang J, Li YM, et al. A bacterially expressed particulate hepatitis E vaccine: antigenicity, immunogenicity and protectivity on primates. Vaccine. 2005;23(22):2893–2901. DOI:https://doi.org/10.1016/j.vaccine.2004.11.064
- Coffman RL, Sher A, Seder RA. Vaccine adjuvants: putting innate immunity to work. Immunity. 2010;33(4):492–503. DOI:https://doi.org/10.1016/j.immuni.2010.10.002
- Lee S, Nguyen MT. Recent advances of vaccine adjuvants for infectious diseases. Immune Netw. 2015;15(2):51–57. DOI:https://doi.org/10.4110/in.2015.15.2.51
- O'Hagan DT, Fox CB. New generation adjuvants–from empiricism to rational design. Vaccine. 2015;33(Suppl 2):B14–B20. DOI:https://doi.org/10.1016/j.vaccine.2015.01.088
- Maisonneuve C, Bertholet S, Philpott DJ, et al. Unleashing the potential of NOD- and toll-like agonists as vaccine adjuvants. Proc Natl Acad Sci U S A. 2014;111(34):12294–12299. DOI:https://doi.org/10.1073/pnas.1400478111
- Iwasaki A, Medzhitov R. Regulation of adaptive immunity by the innate immune system. Science. 2010;327(5963):291–295. DOI:https://doi.org/10.1126/science.1183021
- Beveridge MG, Polcari IC, Burns JL, et al. Local vaccine site reactions and contact allergy to aluminum. Pediatr Dermatol. 2012;29(1):68–72. DOI:https://doi.org/10.1111/j.1525-1470.2011.01541.x
- Ren K, Dubner R. Interactions between the immune and nervous systems in pain. Nat Med. 2010;16(11):1267–1276. DOI:https://doi.org/10.1038/nm.2234
- Tynan A, Tsaava T, Gunasekaran M, et al. Antibody responses to immunization require sensory neurons. bioRxiv. 2019. DOI:https://doi.org/10.1101/860395
- Lai NY, Musser MA, Pinho-Ribeiro FA, et al. Gut-Innervating nociceptor neurons regulate peyer's patch microfold cells and SFB levels to mediate salmonella host defense. Cell. 2020;180(1):33–49e22. DOI:https://doi.org/10.1016/j.cell.2019.11.014
- Chen WH, Kozlovsky BF, Effros RB, et al. Vaccination in the elderly: an immunological perspective. Trends Immunol. 2009;30(7):351–359. DOI:https://doi.org/10.1016/j.it.2009.05.002
- Yousfi ME, Mercier S, Breuillé D, et al. The inflammatory response to vaccination is altered in the elderly. Mech Ageing Dev. 2005;126(8):874–881. DOI:https://doi.org/10.1016/j.mad.2005.03.008
- Chen Q, Zhao H, Yao X, et al. Comparing immunogenicity of the Escherichia coli-produced bivalent human papillomavirus vaccine in females of different ages. Vaccine. 2020. DOI:https://doi.org/10.1016/j.vaccine.2020.07.030
- Stassijns J, Bollaerts K, Baay M, et al. A systematic review and meta-analysis on the safety of newly adjuvanted vaccines among children. Vaccine. 2016;34(6):714–722. DOI:https://doi.org/10.1016/j.vaccine.2015.12.024
- Del Giudice G, Rappuoli R, Didierlaurent AM. Correlates of adjuvanticity: A review on adjuvants in licensed vaccines. Semin Immunol. 2018;39:14–21. DOI:https://doi.org/10.1016/j.smim.2018.05.001
- Wheeler CM, Skinner SR, Del Rosario-Raymundo MR, et al. Efficacy, safety, and immunogenicity of the human papillomavirus 16/18 AS04-adjuvanted vaccine in women older than 25 years: 7-year follow-up of the phase 3, double-blind, randomised controlled VIVIANE study. Lancet Infect Dis. 2016;16(10):1154–1168. DOI:https://doi.org/10.1016/s1473-3099(16)30120-7
- Roteli-Martins CM, Naud P, De Borba P, et al. 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(3):390–397. DOI:https://doi.org/10.4161/hv.18865
- Zhu FC, Hu SY, Hong Y, et al. Efficacy, immunogenicity and safety of the AS04-HPV-16/18 vaccine in Chinese women aged 18-25 years: End-of-study results from a phase II/III, randomised, controlled trial. Cancer Med. 2019;8(14):6195–6211. DOI:https://doi.org/10.1002/cam4.2399
- Garçon N, Morel S, Didierlaurent A, et al. Development of an AS04-adjuvanted HPV vaccine with the adjuvant system approach. BioDrugs. 2011;25(4):217–226. DOI:https://doi.org/10.2165/11591760-000000000-00000
- Giannini SL, Hanon E, Moris P, 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(33-34):5937–5949. DOI:https://doi.org/10.1016/j.vaccine.2006.06.005
- Kashiwagi Y, Maeda M, Kawashima H, et al. Inflammatory responses following intramuscular and subcutaneous immunization with aluminum-adjuvanted or non-adjuvanted vaccines. Vaccine. 2014;32(27):3393–3401. DOI:https://doi.org/10.1016/j.vaccine.2014.04.018
- Garçon N. Preclinical development of AS04. Methods Mol Biol. 2010;626:15–27. DOI:https://doi.org/10.1007/978-1-60761-585-9_2
- 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:https://doi.org/10.4161/hv.5.10.9518
- Einstein MH, Baron M, Levin MJ, et al. Comparative immunogenicity and safety of human papillomavirus (HPV)-16/18 vaccine and HPV-6/11/16/18 vaccine: follow-up from months 12-24 in a phase III randomized study of healthy women aged 18-45 years. Hum Vaccin. 2011;7(12):1343–1358. DOI:https://doi.org/10.4161/hv.7.12.18281
- Chlibek R, Bayas JM, Collins H, et al. Safety and immunogenicity of an AS01-adjuvanted varicella-zoster virus subunit candidate vaccine against herpes zoster in adults >=50 years of age. J Infect Dis. 2013;208(12):1953–1961. DOI:https://doi.org/10.1093/infdis/jit365
- Keech C, Albert G, Cho I, et al. Phase 1-2 trial of a SARS-CoV-2 recombinant spike protein nanoparticle vaccine. N Engl J Med. 2020;383(24):2320–2332. DOI:https://doi.org/10.1056/NEJMoa2026920
- Vaccines CtRAEo, Medicine Io. Adverse effects of vaccines: evidence and causality. Stratton K, Ford A, Rusch E, Clayton EW, editors. Washington (DC): National Academies Press (US) Copyright 2012 by the National Academy of Sciences. All rights reserved; 2011.