Selected article for: "clinical development and vaccine development"

Author: Roberts, Christine C.
Title: Emerging infectious disease laboratory and diagnostic preparedness to accelerate vaccine development
  • Document date: 2019_7_16
  • ID: v5ei8991_3
    Snippet: The clinical assays with which the immune response and pathogen presence are measured in vaccine trials become part of the basis for licensure for all vaccine products. 2 Because vaccines are tested in healthy populations through all phases of clinical development for immune response and/or pathogen presence, the methods selected to measure vaccine responses and endpoints are critical. While the identification of an immune correlate of protection.....
    Document: The clinical assays with which the immune response and pathogen presence are measured in vaccine trials become part of the basis for licensure for all vaccine products. 2 Because vaccines are tested in healthy populations through all phases of clinical development for immune response and/or pathogen presence, the methods selected to measure vaccine responses and endpoints are critical. While the identification of an immune correlate of protection for each new vaccine is highly desirable, it is not always attainable. 3 Here we will use our recent experiences with the Middle East Respiratory Syndrome coronavirus (MERS-CoV) and Zika virus (ZIKV) 4-9 outbreaks and ensuing public health countermeasures for containment and vaccine development as examples of challenges faced during emerging infectious disease emergencies.

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