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Research Paper

The adjuvanted recombinant zoster vaccine is efficacious and safe in Asian adults ≥ 50 years of age: a sub-cohort analysis of the ZOE-50 and ZOE-70 randomized trials

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Pages 2050-2057 | Received 17 Sep 2020, Accepted 25 Nov 2020, Published online: 19 Feb 2021

References

  • Johnson RW, Alvarez-Pasquin MJ, Bijl M, Franco E, Gaillat J, Clara JG, Labetoulle M, Michel JP, Naldi L, Sanmarti LS, et al. Herpes zoster epidemiology, management, and disease and economic burden in Europe: a multidisciplinary perspective. Ther Adv Vaccin. 2015;3(4):109–20. doi:10.1177/2051013615599151.
  • Kawai K, Gebremeskel BG, Acosta CJ. Systematic review of incidence and complications of herpes zoster: towards a global perspective. BMJ Open. 2014;4(6):e004833. doi:10.1136/bmjopen-2014-004833.
  • Yawn BP, Gilden D. The global epidemiology of herpes zoster. Neurology. 2013;81(10):928–30. doi:10.1212/WNL.0b013e3182a3516e.
  • Johnson RW, Bouhassira D, Kassianos G, Leplege A, Schmader KE, Weinke T. The impact of herpes zoster and post-herpetic neuralgia on quality-of-life. BMC Med. 2010;8(1):37. doi:10.1186/1741-7015-8-37.
  • Schmader KE, Sloane R, Pieper C, Coplan PM, Nikas A, Saddier P, Chan IS, Choo P, Levin MJ, Johnson G, et al. The impact of acute herpes zoster pain and discomfort on functional status and quality of life in older adults. Clin J Pain. 2007;23(6):490–96. doi:10.1097/AJP.0b013e318065b6c9.
  • van Wijck AJM, Aerssens YR. Pain, itch, quality of life, and costs after herpes zoster. Pain Pract. 2017;17(6):738–46. doi:10.1111/papr.12518.
  • Chakravarty E. Incidence and prevention of herpes zoster reactivation in patients with autoimmune diseases. Rheum Dis Clin North Am. 2017;43:111–21. doi:10.1016/j.rdc.2016.09.010.
  • Insinga RP, Itzler RF, Pellissier JM, Saddier P, Nikas AA. The incidence of herpes zoster in a United States administrative database. J Gen Intern Med. 2005;20(8):748–53. doi:10.1111/j.1525-1497.2005.0150.x.
  • Kawai K, Rampakakis E, Tsai TF, Cheong HJ, Dhitavat J, Covarrubias AO, Yang L, Cashat-Cruz M, Monsanto H, Johnson K, et al. Predictors of postherpetic neuralgia in patients with herpes zoster: a pooled analysis of prospective cohort studies from North and Latin America and Asia. Int J Infect Dis. 2015;34:126–31. doi:10.1016/j.ijid.2015.03.022.
  • Mallick-Searle T, Snodgrass B, Brant JM. Postherpetic neuralgia: epidemiology, pathophysiology, and pain management pharmacology. J Multidiscip Healthc. 2016;9:447–54. doi:10.2147/jmdh.s106340.
  • Kawai K, Yawn BP. Risk factors for herpes zoster: A systematic review and meta-analysis. Mayo Clin Proc. 2017;92(12):1806–21. doi:10.1016/j.mayocp.2017.10.009.
  • Lecrenier N, Beukelaers P, Colindres R, Curran D, De Kesel C, De Saegher JP, Didierlaurent AM, Ledent EY, Mols JF, Mrkvan T, et al. Development of adjuvanted recombinant zoster vaccine and its implications for shingles prevention. Expert Rev Vaccines. 2018;17(7):619–34. doi:10.1080/14760584.2018.1495565.
  • Lal H, Cunningham AL, Godeaux O, Chlibek R, Diez-Domingo J, Hwang SJ, Levin MJ, McElhaney JE, Poder A, Puig-Barbera J, et al. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med. 2015;372(22):2087–96. doi:10.1056/NEJMoa1501184.
  • Cunningham AL, Lal H, Kovac M, Chlibek R, Hwang SJ, Diez-Domingo J, Godeaux O, Levin MJ, McElhaney JE, Puig-Barbera J, et al. Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med. 2016;375(11):1019–32. doi:10.1056/NEJMoa1603800.
  • Willer DO, Oostvogels L, Cunningham AL, Gervais P, Gorfinkel I, Hyung Kim J, Talarico C, Wascotte V, Zahaf T, Colindres R, et al. Efficacy of the adjuvanted recombinant zoster vaccine (RZV) by sex, geographic region, and geographic ancestry/ethnicity: A post-hoc analysis of the ZOE-50 and ZOE-70 randomized trials. Vaccine. 2019;37(43):6262–67. doi:10.1016/j.vaccine.2019.09.028.
  • Dooling KL, Guo A, Patel M, Lee GM, Moore K, Belongia EA, Harpaz R. Recommendations of the advisory committee on immunization practices for use of herpes zoster vaccines. MMWR Morb Mortal Wkly Rep. 2018;67(3):103–08. doi:10.15585/mmwr.mm6703a5.
  • European Medicines Agency. Shingrix. Available at https://www.ema.europa.eu/en/medicines/human/EPAR/shingrix Accessed on 03 Sept 2019.
  • Shingrix approved in Europe and Japan for the prevention of shingles in adults aged 50 and over. Available at https://www.gsk.com/en-gb/media/press-releases/shingrix-approved-in-europe-and-japan-for-the-prevention-of-shingles-in-adults-aged-50-and-over/ Accessed 13 March 2020.
  • National Medical Products Administration. Recombinant shingles vaccine approved for marketing. Available at http://www.nmpa.gov.cn/WS04/CL2056/337895.html Accessed 13 March 2020.
  • Li Y, An Z, Yin D, Liu Y, Huang Z, Xu J, Ma Y, Tu Q, Li Q, Wang H. disease burden due to herpes zoster among population aged ≥50 years old in China: a community based retrospective survey. PLoS One. 2016;11(4):e0152660. doi:10.1371/journal.pone.0152660.
  • Lu L, Suo L, Li J, Pang X. A retrospective survey on herpes zoster disease burden and characteristics in Beijing, China. Hum Vaccin Immunother. 2018;14:2632–35. doi:10.1080/21645515.2018.1489193.
  • Lu WH, Lin CW, Wang CY, Chen LK, Hsiao FY. Epidemiology and long-term disease burden of herpes zoster and postherpetic neuralgia in Taiwan: a population-based, propensity score-matched cohort study. BMC Public Health. 2018;18(1):369. doi:10.1186/s12889-018-5247-6.
  • Zhu Q, Zheng H, Qu H, Deng H, Zhang J, Ma W, Lin Y, Xie X, Qiu Q, Huang Z. Epidemiology of herpes zoster among adults aged 50 and above in Guangdong, China. Hum Vaccin Immunother. 2015;11(8):2113–18. doi:10.1080/21645515.2015.1016672.
  • Chen LK, Arai H, Chen LY, Chou MY, Djauzi S, Dong B, Kojima T, Kwon KT, Leong HN, Leung EM, et al. Looking back to move forward: a twenty-year audit of herpes zoster in Asia-Pacific. BMC Infect Dis. 2017;17:213. doi:10.1186/s12879-017-2198-y.
  • Tavares Da Silva F, De Keyser F, Lambert PH, Robinson WH, Westhovens R, Sindic C. Optimal approaches to data collection and analysis of potential immune mediated disorders in clinical trials of new vaccines. Vaccine. 2013;31(14):1870–76. doi:10.1016/j.vaccine.2013.01.042.
  • Lopez-Fauqued M, Campora L, Delannois F, El Idrissi M, Oostvogels L, De Looze FJ, Diez-Domingo J, Heineman TC, Lal H, McElhaney JE, et al. Safety profile of the adjuvanted recombinant zoster vaccine: pooled analysis of two large randomised phase 3 trials. Vaccine. 2019;37(18):2482–93. doi:10.1016/j.vaccine.2019.03.043.
  • Oostvogels L, Heineman TC, Johnson RW, Levin MJ, McElhaney JE, Van den Steen P, Zahaf T, Dagnew AF, Chlibek R, Diez-Domingo J, et al. Medical conditions at enrollment do not impact efficacy and safety of the adjuvanted recombinant zoster vaccine: a pooled post-hoc analysis of two parallel randomized trials. Hum Vaccin Immunother. 2019;15(12):2865–72. doi:10.1080/21645515.2019.1627818.
  • Ikematsu H, Yamashita N, Ogawa M, Hirano M, Kovac M, Watanabe D. Efficacy, safety and immunogenicity of a novel adjuvanted subunit herpes zoster vaccine in Japanese aged 50 years and 70 years and older. Kansenshogaku Zasshi. 2018;92(2):103–14. doi:10.11150/kansenshogakuzasshi.92.103.
  • Curran D, Oostvogels L, Heineman T, Matthews S, McElhaney J, McNeil S, Diez-Domingo J, Lal H, Andrews C, Athan E, et al. Quality of life impact of an adjuvanted recombinant zoster vaccine in adults aged 50 years and older. J Gerontol A Biol Sci Med Sci. 2019;74(8):1231–38. doi:10.1093/gerona/gly150.
  • Colindres R, Wascotte V, Brecx A, Clarke C, Hervé C, Kim JH, Levin MJ, Oostvogels L, Zahaf T, Schuind A, et al. Post hoc analysis of reactogenicity trends between dose 1 and dose 2 of the adjuvanted recombinant zoster vaccine in two parallel randomized trials. Hum Vaccin Immunother. 2020;1–6. doi:10.1080/21645515.2020.1741312.