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Review
. 2021 Sep 7;39(38):5436-5441.
doi: 10.1016/j.vaccine.2021.07.030. Epub 2021 Aug 7.

A Brighton Collaboration standardized template with key considerations for a benefit/risk assessment for a soluble glycoprotein vaccine to prevent disease caused by Nipah or Hendra viruses

John H Eldridge  1 , Michael A Egan  1 , Demetrius Matassov  1 , Stefan Hamm  1 , Luz Hermida  1 , Tracy Chen  1 , Marc Tremblay  1 , Susan Sciotto-Brown  1 , Rong Xu  2 , Antony Dimitrov  3 , Emily R Smith  4 , Marc Gurwith  5 , Robert T Chen  5 ; Benefit-Risk Assessment of VAccines by TechnolOgy Working Group BRAVATO, ex-V3SWG)
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Free article
Review

A Brighton Collaboration standardized template with key considerations for a benefit/risk assessment for a soluble glycoprotein vaccine to prevent disease caused by Nipah or Hendra viruses

John H Eldridge et al. Vaccine. .
Free article

Abstract

Auro Vaccines LLC has developed a protein vaccine to prevent disease from Nipah and Hendra virus infection that employs a recombinant soluble Hendra glycoprotein (HeV-sG) adjuvanted with aluminum phosphate. This vaccine is currently under clinical evaluation in a Phase 1 study. The Benefit-Risk Assessment of VAccines by TechnolOgy Working Group (BRAVATO; ex-V3SWG) has prepared a standardized template to describe the key considerations for the benefit-risk assessment of protein vaccines. This will help key stakeholders to assess potential safety issues and understand the benefit-risk of such a vaccine platform. The structured and standardized assessment provided by the template may also help contribute to improved public acceptance and communication of licensed protein vaccines.

Keywords: Benefit/Risk; Hendra; Nipah; Protein; Safety; Vaccine.

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Conflict of interest statement

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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