Vaccines: Underlying Principles of Design and Testing

Clin Pharmacol Ther. 2021 Apr;109(4):987-999. doi: 10.1002/cpt.2207. Epub 2021 Mar 11.

Abstract

In this paper, we review the key elements that should be considered to take a novel vaccine from the laboratory through to licensure in the modern era. This paper is divided into four sections. First, we discuss the host immune responses that we engage with vaccines. Second, we discuss how in vivo and in vitro studies can inform vaccine design. Third, we discuss different vaccine modalities that have been licensed or are in testing in humans. Last, we overview the basic principles of vaccine approvals. Throughout we provide real-world examples of vaccine development against infectious diseases, including coronavirus disease 2019 (COVID-19).

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Adjuvants, Immunologic / pharmacology
  • Drug Approval / organization & administration*
  • Drug Design
  • Drug Evaluation, Preclinical
  • Immunity, Herd / immunology
  • Immunity, Innate / immunology
  • Public Health
  • United States
  • United States Food and Drug Administration
  • Vaccines / immunology*

Substances

  • Adjuvants, Immunologic
  • Vaccines