Clinical development of a novel inactivated poliomyelitis vaccine based on attenuated Sabin poliovirus strains

Abstract

Following achievement of polio eradication, the routine use of all live-attenuated oral poliovirus vaccines should be discontinued. However, the costs per vaccine dose for the alternative inactivated poliovirus vaccine (IPV) are significantly higher and the current production capacity is not sufficient for worldwide distribution of the vaccine. In order to achieve cost–prize reduction and improve affordability, IPV production processes and dose-sparing strategies should be developed to facilitate local manufacture at a relatively lower cost. The use of attenuated Sabin instead of wild-type polio strains will provide additional safety during vaccine production and permits production in low-cost settings. Sabin-IPV is under development by several manufacturers. This article gives an overview of results from clinical trials with Sabin-IPV and discusses the requirements and challenges in the clinical development of this novel IPV.

Keywords::

• clinical trial
• inactivated poliomyelitis vaccine
• polio eradication
• poliomyelitis
• Sabin-IPV
• vaccine development

Acknowledgements

We thank Monique van Oijen, Roland Sutter and Jacqueline Fournier-Caruana for critical reading of this paper.

Financial & competing interests disclosure

This work was supported by the WHO using funds provided by a grant from the Bill and Melinda Gates Foundation. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.