1,350
Views
0
CrossRef citations to date
0
Altmetric
Licensed Vaccines – Research Paper

A comparison of the test-negative and the matched case-control study designs for estimation of EV71 vaccine immunological surrogate endpoints from a randomized controlled trial

, , , , & ORCID Icon
Article: 2073751 | Received 08 Nov 2021, Accepted 03 Apr 2022, Published online: 09 Jun 2022

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. Eurosurveillance. 2017;22(50): 16–6. doi:10.2807/1560-7917.ES.2017.22.50.16-00824.
  • 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.
  • 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(9):818–28. 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(9):829–37. doi:10.1056/NEJMoa1303224.
  • Zhu F-C, Meng F-Y, Li J-X, Li X-L, Mao Q-Y, Tao H, Zhang Y-T, Yao X, Chu K, Chen Q-H, 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. Lancet. 2013;381(9882):2024–32. doi:10.1016/s0140-6736(13)61049-1.
  • Fan S, Liao Y, Jiang G, Wang L, Zhao H, Yu L, Xu X, Li D, Zhang Y, Li Q, et al. Efficacy of an inactivated bivalent vaccine for enterovirus 71 and coxsackievirus A16 in mice immunized intradermally. Vaccine. 2021;39(3):596–604. doi:10.1016/j.vaccine.2020.11.070.
  • Chen K, Li C, Wang Y, Shen Z, Guo Y, Li X, Zhang Y. Optimization of Vero cells grown on a polymer fiber carrier in a disposable bioreactor for inactivated Coxsackievirus A16 vaccine development. Vaccines. 2021;9(6):613. doi:10.3390/vaccines9060613.
  • Jackson ML, Nelson JC. The test-negative design for estimating influenza vaccine effectiveness. Vaccine. 2013;31(17):2165–68. doi:10.1016/j.vaccine.2013.02.053.
  • Foppa IM, Haber M, Ferdinands JM, Shay DK. The case test-negative design for studies of the effectiveness of influenza vaccine. Vaccine. 2013;31(30):3104–09. doi:10.1016/j.vaccine.2013.04.026.
  • Fukushima W, Hirota Y. Basic principles of test-negative design in evaluating influenza vaccine effectiveness. Vaccine. 2017;35(36):4796–800. doi:10.1016/j.vaccine.2017.07.003.
  • Haber M, Lopman BA, Tate JE, Shi M, Parashar UD. A comparison of the test-negative and traditional case-control study designs with respect to the bias of estimates of rotavirus vaccine effectiveness. Vaccine. 2018;36(33):5071–76. doi:10.1016/j.vaccine.2018.06.072.
  • Araki K, Hara M, Shimanoe C, Nishida Y, Matsuo M, Tanaka K. Case-control study of Rotavirus vaccine effectiveness compared to test-negative controls or hospital controls. J Epidemiol. 2018;29(8):282–87. doi:10.2188/jea.JE20180054.
  • Shi M, An Q, Ainslie KEC, Haber M, Orenstein WA. A comparison of the test-negative and the traditional case-control study designs for estimation of influenza vaccine effectiveness under nonrandom vaccination. BMC Infect Dis. 2017;17(1):757. doi:10.1186/s12879-017-2838-2.
  • Liang Z, Mao Q, Gao Q, Li X, Dong C, Yu X, Yao X, Li F, Yin W, Li Q, et al. Establishing China’s national standards of antigen content and neutralizing antibody responses for evaluation of enterovirus 71 (EV71) vaccines. Vaccine. 2011;29(52):9668–74. doi:10.1016/j.vaccine.2011.10.018.
  • Chen YJ, Meng FY, Mao Q, Li J-X, Wang H, Liang Z-L, Zhang Y-T, Gao F, Chen Q-H, Hu Y, et al. Clinical evaluation for batch consistency of an inactivated enterovirus 71 vaccine in a large-scale phase 3 clinical trial. Hum Vaccines Immunother. 2014;10(5):1366–72. doi:10.4161/hv.28397.
  • Zhu W, Jin P, Li JX, Zhu FC, Liu P. Correlates of protection for inactivated enterovirus 71 vaccine: the analysis of immunological surrogate endpoints. Expert Rev Vaccines. 2017;16(9):945–49. doi:10.1080/14760584.2017.1335603.
  • Jin P, Li J, Zhang X, Meng F, Zhou Y, Yao X, Gan Z, Zhu F. Validation and evaluation of serological correlates of protection for inactivated enterovirus 71 vaccine in children aged 6-35 months. Hum Vaccines Immunother. 2016;12(4):916–21. doi:10.1080/21645515.2015.1118595.
  • Zhang L, Wei M, Jin P, Li J, Zhu F. An evaluation of a test-negative design for EV-71 vaccine from a randomized controlled trial. Hum Vaccines Immunother. 2021;17(7):2101–06. doi:10.1080/21645515.2020.1859900.
  • Sadoff JC, Wittes J. Correlates, surrogates, and vaccines. J Infect Dis. 2007;196(9):1279–81. doi:10.1086/522432.
  • Verani JR, Baqui AH, Broome CV, Cherian T, Cohen C, Farrar JL, Feikin DR, Groome MJ, Hajjeh RA, Johnson HL, et al. Case-Control vaccine effectiveness studies: preparation, design, and enrollment of cases and controls. Vaccine. 2017;35(25):3295–302. doi:10.1016/j.vaccine.2017.04.037.
  • Verani JR, Baqui AH, Broome CV, Cherian T, Cohen C, Farrar JL, Feikin DR, Groome MJ, Hajjeh RA, Johnson HL, et al. Case-Control vaccine effectiveness studies: data collection, analysis and reporting results. Vaccine. 2017;35(25):3303–08. doi:10.1016/j.vaccine.2017.04.035.
  • Balasubramani GK, Zimmerman RK, Eng H, Lyons J, Clarke L, Nowalk MP. Comparison of local influenza vaccine effectiveness using two methods. Vaccine. 2021;39(8):1283–89. doi:10.1016/j.vaccine.2021.01.013.
  • Franke MF, Jerome JG, Matias WR, Ternier R, Hilaire IJ, Harris JB, Ivers LC. Comparison of two control groups for estimation of oral cholera vaccine effectiveness using a case-control study design. Vaccine. 2017;35(43):5819–27. doi:10.1016/j.vaccine.2017.09.025.
  • Follmann DA, Dodd L. Immune correlates analysis using vaccines from test negative designs. Biostatistics. 2020. doi:10.1093/biostatistics/kxaa037.
  • Sullivan SG, Tchetgen Tchetgen EJ, Cowling BJ. Theoretical basis of the test-negative study design for assessment of influenza vaccine effectiveness. Am J Epidemiol. 2016;184(5):345–53. doi:10.1093/aje/kww064.