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Research Paper

An evaluation of a test-negative design for EV-71 vaccine from a randomized controlled trial

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Pages 2101-2106 | Received 19 Aug 2020, Accepted 30 Nov 2020, Published online: 02 Feb 2021

References

  • Yang B, Liu F, Liao Q, Wu P, Chang Z, Huang J, Long L, Luo L, Li Y, Leung GM, et al. Epidemiology of hand, foot and mouth disease in China, 2008 to 2015 prior to the introduction of EV-A71 vaccine. Euro surveillance: bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin 2017; 22(50):16–00824. PMID: 29258646, PMCID: PMC5743100. doi:10.2807/1560-7917.ES.2017.22.50.16-00824.
  • Liu SL, Pan H, Liu P, Amer S, Chan TC, Zhan J, Huo X, Liu Y, Teng Z, Wang L, et al. Comparative epidemiology and virology of fatal and nonfatal cases of hand, foot and mouth disease in mainland China from 2008 to 2014. Rev Med Virol. 2015;25:115–28. Epub 2015 Feb 20, PMID: 25704797. doi:10.1002/rmv.1827.
  • Xing W, Liao Q, Viboud C, Zhang J, Sun J, Wu JT, Chang Z, Liu F, Fang VJ, Zheng Y, et al. Hand, foot, and mouth disease in China, 2008–12: an epidemiological study. Lancet Infect Dis. 2014;14:308–18. Epub 2014 Jan 31, PMID: 24485991, PMCID: PMC4035015. doi:10.1016/S1473-3099(13)70342-6.
  • Abzug MJ. The enteroviruses: problems in need of treatments. J Infect. 2014;68(Suppl 1):S108–14. doi:10.1016/j.jinf.2013.09.020.
  • Li Y, Zhou Y, Cheng Y, Wu P, Zhou C, Cui P, Song C, Liang L, Wang F, Qiu Q, et al. Effectiveness of EV-A71 vaccination in prevention of paediatric hand, foot, and mouth disease associated with EV-A71 virus infection requiring hospitalisation in Henan, China, 2017–18: a test-negative case-control study. Lancet Child Adolesc Health. 2019;3:697–704. Epub 2019 Jul 30, PMID: 31375313. doi:10.1016/S2352-4642(19)30185-3.
  • Zhu F, Xu W, Xia J, Liang Z, Liu Y, Zhang X, Tan X, Wang L, Mao Q, Wu J, et al. Efficacy, safety, and immunogenicity of an enterovirus 71 vaccine in China. N Engl J Med. 2014;370:818–28. PMID: 24571754. doi:10.1056/NEJMoa1304923.
  • Li R, Liu L, Mo Z, Wang X, Xia J, Liang Z, Zhang Y, Li Y, Mao Q, Wang J, et al. An inactivated enterovirus 71 vaccine in healthy children. N Engl J Med. 2014;370:829–37. PMID: 24571755. doi:10.1056/NEJMoa1303224.
  • Zhu F-C, Meng F-Y, Li J-X, Li X-L, Mao Q-Y, Tao H, Zhang YT, Yao X, Chu K, Chen QH, et al. Efficacy, safety, and immunology of an inactivated alum-adjuvant enterovirus 71 vaccine in children in China: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet. 2013;381:2024–32. Epub 2013 May 29, PMID: 23726161. doi:10.1016/S0140-6736(13)61049-1.
  • Wang X, An Z, Huo D, Jia L, Li J, Yang Y, Liang Z, Wang Q, Wang H. Enterovirus A71 vaccine effectiveness in preventing enterovirus A71 infection among medically-attended hand, foot, and mouth disease cases, Beijing, China. Hum Vaccin Immunother. 2019;15:1183–90.doi:10.1080/21645515.2019.1581539.
  • Jiang L, Wang J, Zhang C, He W, Mo J, Zeng J, Chen M, Tan Y, Ning C. Effectiveness of enterovirus A71 vaccine in severe hand, foot, and mouth disease cases in Guangxi, China. Vaccine 2019;38(7):1804–09.  Epub 2019 Dec 28, PMID: 31892446. doi: 10.1016/j.vaccine.2019.12.025.
  • Zhang D. A template for EV-A71 vaccine evaluation in the real world. Lancet Child Adolesc Health. 2019;3:665–66. doi:10.1016/S2352-4642(19)30181-6.
  • Foppa IM, Haber M, Ferdinands JM, Shay DK. The case test-negative design for studies of the effectiveness of influenza vaccine. Vaccine. 2013;31:3104–09. doi:10.1016/j.vaccine.2013.04.026.
  • Araki K, Hara M, Tsugawa T, Shimanoe C, Nishida Y, Matsuo M, Tanaka K. Effectiveness of monovalent and pentavalent rotavirus vaccines in Japanese children. Vaccine. 2018;36:5187–93.  Epub 2018 Jul 20, PMID: 30037664. doi:10.1016/j.vaccine.2018.07.007.
  • Jackson ML, Nelson JC. The test-negative design for estimating influenza vaccine effectiveness. Vaccine. 2013;31:2165–68. doi:10.1016/j.vaccine.2013.02.053.
  • De Serres G, Skowronski DM, Wu XW, Ambrose CS The test-negative design: validity, accuracy and precision of vaccine efficacy estimates compared to the gold standard of randomised placebo-controlled clinical trials. Euro surveillance: bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin 2013; 18.
  • WPRO | A Guide to Clinical Management and Public Health Response for Hand, Foot and Mouth disease (HFMD).
  • Schwartz LM, Halloran ME, Rowhani-Rahbar A, Neuzil KM, Victor JC. Rotavirus vaccine effectiveness in low-income settings: an evaluation of the test-negative design. Vaccine. 2017;35:184–90. doi:10.1016/j.vaccine.2016.10.077.
  • Sullivan SG, Feng S, Cowling BJ. Potential of the test-negative design for measuring influenza vaccine effectiveness: a systematic review. Expert Rev Vaccines. 2014;13:1571–91. doi:10.1586/14760584.2014.966695.
  • Chua H, Feng S, Lewnard JA, Sullivan SG, Blyth CC, Lipsitch M, Cowling BJ. The Use of Test-negative Controls to Monitor Vaccine Effectiveness: A Systematic Review of Methodology. Epidemiology (Cambridge, Mass). 2020;31:43–64. PMID: 31609860, PMCID: PMC6888869. doi:10.1097/EDE.0000000000001116.
  • Lewnard JA, Tedijanto C, Cowling BJ, Lipsitch M. Measurement of Vaccine Direct Effects Under the Test-Negative Design. Am J Epidemiol. 2018;187:2686–97. doi:10.1093/aje/kwy163.
  • Jackson ML, Rothman KJ. Effects of imperfect test sensitivity and specificity on observational studies of influenza vaccine effectiveness. Vaccine. 2015;33:1313–16. doi:10.1016/j.vaccine.2015.01.069.
  • Fukushima W, Hirota Y. Basic principles of test-negative design in evaluating influenza vaccine effectiveness. Vaccine. 2017;35:4796–800. doi:10.1016/j.vaccine.2017.07.003.
  • Bar-Zeev N, Kapanda L, Tate JE, Jere KC, Iturriza-Gomara M, Nakagomi O, Mwansambo C, Costello A, Parashar UD, Heyderman RS, et al. Effectiveness of a monovalent rotavirus vaccine in infants in Malawi after programmatic roll-out: an observational and case-control study. Lancet Infect Dis. 2015;15:422–28.  PMID: 25638521, PMCID: PMC4374102. doi:10.1016/S1473-3099(14)71060-6.
  • Rolfes MA, Flannery B, Chung J, O’Halloran A, Garg S, Belongia EA, Gaglani M, Zimmerman RK, Jackson ML, Monto AS, et al. Effects of Influenza Vaccination in the United States during the 2017-2018 Influenza Season. Clin Infect Dis 2019;69(11):1845–53. PMID: 30715278; PMCID: PMC7188082.  doi: 10.1093/cid/ciz075.
  • Gu W, Zeng G, Hu Y-M, Hu Y-S, Zhang Y, Hu Y-L, Wang Y, Li JX, Zhu FC. A comparative analysis of immunogenicity and safety of an enterovirus 71 vaccine between children aged 3-5 years and infants aged 6-35 months. Expert Rev Vaccines. 2018;17:257–62. Epub 2018 Jan 29, PMID: 29363365. doi:10.1080/14760584.2018.1430572.
  • Flannery B, Chung JR, Monto AS, Martin ET, Belongia EA, McLean HQ, Gaglani M, Murthy K, Zimmerman RK, Nowalk MP, et al. Influenza Vaccine Effectiveness in the United States during the 2016-2017 Season. Clinical infectious diseases: an official publication of the Infectious Diseases Society of America 2018.  Clin Infect Dis. 2019;68(11):1798–1806. PMID: 30204854, PMCID: PMC6522684. doi: 10.1093/cid/ciy775.
  • Jackson ML, Chung JR, Jackson LA, Phillips CH, Benoit J, Monto AS, Martin ET, Belongia EA, McLean HQ, Gaglani M, et al. Influenza Vaccine Effectiveness in the United States during the 2015-2016 Season. N Engl J Med. 2017;377:534–43.  PMID: 28792867, PMCID: PMC5727917. doi:10.1056/NEJMoa1700153.

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