How can controlled human infection models accelerate clinical development and policy pathways for vaccines against

Birgitte K Giersing1, Chad K Porter2, Karen Kotloff3

  • 1Initiative for Vaccine Research, Department of Immunization, Vaccines & Biologicals, World Health Organization Headquarters, 20 Avenue Appia, 1211-CH 27 Geneva, Switzerland.

Vaccine
|July 31, 2019
PubMed

Insights

Controlled Human Infection Models (CHIMs) provide valuable insights into disease pathogenesis and vaccine development. CHIMs show promise for identifying correlates of protection, potentially streamlining vaccine licensure and efficacy studies.

Area of Science:

  • Infectious diseases
  • Vaccinology
  • Immunology

Background:

  • Controlled Human Infection Models (CHIMs) are established for various infectious diseases.
  • CHIMs offer deep insights into disease pathogenesis.
  • They enable rapid clinical proof-of-concept testing for vaccine candidates.

Purpose of the Study:

  • To explore the utility of CHIMs in identifying correlates of protection.
  • To discuss how correlates of protection can reduce sample sizes for clinical efficacy studies.
  • To examine the application of CHIMs in the context of Shigella vaccine development.

Main Methods:

  • Workshop discussion at the 2018 Vaccines Against Shigella and ETEC (VASE) conference.
  • Focus on O-antigen-based Shigella vaccines.
  • Review of existing CHIM applications and potential for correlate identification.

Main Results:

  • CHIMs are a valuable tool for understanding pathogenesis.
  • Identifying correlates of protection via CHIMs is of significant interest.
  • CHIMs can potentially reduce the need for large-scale efficacy trials.

Conclusions:

  • CHIMs are crucial for advancing vaccine development and understanding disease.
  • Correlates of protection identified through CHIMs can accelerate vaccine licensure.
  • Further research into CHIMs for Shigella vaccines is warranted.

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