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Human Vaccines & Immunotherapeutics Volume 16, 2020 - Issue 11
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Research Paper

A phase Ⅱ, randomized, controlled trial to evaluate the safety and immunogenicity of a Sabin strain-based inactivated polio vaccine

Rong Tanga Department of Vaccine Clinical Evaluation, Jiangsu Provincial Center for Disease Control and Prevention (Public Health Research Institute of Jiangsu Province), Jiangsu, ChinaView further author information
,
Guifan Lib Department of Registration, Beijing Minhai Biotechnology Co. Ltd, Beijing, ChinaView further author information
,
Chengfu Zhangc Department of Infectious Disease Control and Prevention, Lianshui County Center for Disease Control and Prevention, Lianshui, Jiangsu, ChinaView further author information
,
Hengkui Zhid Department of Infectious Disease Control and Prevention, Dafeng County Center for Disease Control and Prevention, Dafeng, Jiangsu, ChinaView further author information
,
Jiahong Zhuc Department of Infectious Disease Control and Prevention, Lianshui County Center for Disease Control and Prevention, Lianshui, Jiangsu, ChinaView further author information
,
Jianjun Wangd Department of Infectious Disease Control and Prevention, Dafeng County Center for Disease Control and Prevention, Dafeng, Jiangsu, ChinaView further author information
,
Qi Lianga Department of Vaccine Clinical Evaluation, Jiangsu Provincial Center for Disease Control and Prevention (Public Health Research Institute of Jiangsu Province), Jiangsu, ChinaCorrespondence[email protected]
View further author information
,
Yuemei Hua Department of Vaccine Clinical Evaluation, Jiangsu Provincial Center for Disease Control and Prevention (Public Health Research Institute of Jiangsu Province), Jiangsu, ChinaView further author information
&
Changgui Lie Division of Respiratory Virus Vaccines, National Institute for Food and Drug Control, Beijing, ChinaView further author information
 show all
Pages 2641-2648 | Received 23 Nov 2019, Accepted 16 Mar 2020, Published online: 29 Apr 2020

References

  • Global Polio Eradication Initiative. Polio prevention. [accessed 2019 July 3]. http://polioeradication.org/polio-today/polio-prevention/.
  • Tang R, Chu K, Hu Y, Chen L, Zhang M, Liu S, Ma H, Wang J, Zhu F, Hu Y, et al. Effect of maternal antibody on the infant immune response to inactivated poliovirus vaccines made from Sabin strains. Hum Vaccin Immunother. 2019;15(5):1160–66. doi:10.1080/21645515.2019.1572410.
  • World Health Assembly: Global Eradication of Poliomyelitis by the Year 2000. Geneva (Switzerland): World Health Organization; 1988.
  • Li R, Li C, Wang H, Luo H, Li Y, Wang J, Ying Z, Yu W, Shu J, Wen N, et al. Immunogenicity of two different sequential schedules of inactivated polio vaccine followed by oral polio vaccine versus oral polio vaccine alone in healthy infants in China. J Pediatric Infect Dis Soc. 2016 Sep;5(3):287–96. doi:10.1093/jpids/piv017.
  • Platt LR, Estivariz CF, Sutter RW. Vaccine-associated paralytic poliomyelitis: a review of the epidemiology and estimation of the global burden. J Infect Dis. 2014 Nov 1;210(Suppl 1):S380–9. doi:10.1093/infdis/jiu184.
  • Burns CC, Diop OM, Sutter RW, Kew OM. Vaccine-derived polioviruses. J Infect Dis. 2014;210(Suppl 1):S283–93. doi:10.1093/420infdis/jiu295.
  • Vaccines & Biologicals Department: Report of the interim meeting of the Technical Consultative Group (TCG) on the Global Eradication of Poliomyelitis, Geneva, 13–14 November 2002. Geneva (Switzerland): World Health Organization; 2004. WHO/V&B/03.04.
  • John TJ. The final stages of the global eradication of polio. N Engl J Med. 2000 Sep 14;343(11):806–07. doi:10.1056/NEJM200009143431111.
  • Global Polio Eradication Initiative. Polio eradication and endgame strategic plan 2013-2018. [accessed 2019 July 3]. http://polioeradication.org/who-we-are/strategic-plan-2013-2018/.
  • Global Polio Eradication Initiative. IPV. [accessed 2019 July 3]. http://polioeradication.org/polio-today/polio-prevention/the-vaccines/ipv/.
  • Liao G, Li R, Li C, Sun M, Li Y, Chu J, Jiang S, Li Q. Safety and immunogenicity of inactivated poliovirus vaccine made from Sabin strains: a phase II, randomized, positive-controlled trial. J Infect Dis. 2012;205(2):237–43. doi:10.1093/infdis/jir723.
  • Verdijk P, Rots NY, van Oijen MG, Oberste MS, Boog CJ, Okayasu H, Sutter RW, Bakker WAM. Safety and immunogenicity of inactivated poliovirus vaccine based on Sabin strains with and without aluminum hydroxide: a phase I trial in healthy adults. Vaccine. 2013 Nov 12;31(47):5531–36. doi:10.1016/j.vaccine.2013.09.021.
  • Okayasu H, Sein C, Hamidi A, Bakker WA, Sutter RW.Development of inactivated poliovirus vaccine from Sabin strains: a progress report. Biologicals. 2016 Nov. 44(6):581–87. doi:10.1016/j.biologicals.2016.08.005.
  • Tang R, Liang Q, Li G, Zhi H, Wang J, Hu Y. Safety and immunogenicity of an inactivated poliovirus vaccine made from Sabin strains. Chin J Public Health. in press.
  • Hu Y, Wang J, Zeng G, Chu K, Jiang D, Zhu F, Ying Z, Chen L, Li C, Zhu F, et al. Immunogenicity and safety of a Sabin strain–based inactivated polio vaccine: a phase 3 clinical trial. J Infect Dis. 2019 Oct 8;220(10):1551–57. doi:10.1093/infdis/jiy736.
  • World Health Organization. WHO expanded program on immunization, manual for the virologic investigation of poliomyelitis. Geneva (Switzerland): World Health Organization; 1990.
  • Chinese State Food and Drug Administration (CFDA). The guidance principle of grade standard for adverse reactions that occur in clinical trial of prevention vaccines. Register no. 493. Beijing (China): CFDA; 2005.
  • Chinese State Food and Drug Administration (CFDA). Technical guidelines for vaccine clinical trials. Register no. 575. Beijing (China): CFDA; 2004.
  • Liao G, Li R, Li C, Sun M, Jiang S, Li Y, Mo Z, Xia J, Xie Z, Che Y, et al. Phase 3 trial of a Sabin strain-based inactivated poliovirus vaccine. J Infect Dis. 2016;214(11):1728–34. doi:10.1093/infdis/jiw433.
  • Verdijk P, Rots NY, Bakker WA.Clinical development of a novel inactivated poliomyelitis vaccine based on attenuated Sabin poliovirus strains. Expert Rev Vaccines. 2011 May. 10(5):635–44. doi:10.1586/erv.11.51.
  • Chu K, Ying Z, Wang L, Hu Y, Xia J, Chen L, Wang J, Li C, Zhang Q, Gao Q, et al. Safety and immunogenicity of inactivated poliovirus vaccine made from Sabin strains: a phase II, randomized, dose-finding trial. Vaccine. 2018 Oct 29;36(45):6782–89. doi:10.1016/j.vaccine.2018.09.023.
  • Hu Y, Xu K, Han W, Chu K, Jiang D, Wang J, Tian X, Ying Z, Zhang Y, Li C, et al. Safety and immunogenicity of Sabin strain inactivated poliovirus vaccine compared with salk strain inactivated poliovirus vaccine, in different sequential schedules with bivalent oral poliovirus vaccine: randomized controlled noninferiority clinical trials in China. Open Forum Infect Dis. 2019 Aug 26;6(10):ofz380. doi:10.1093/ofid/ofz380.

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