Testing vaccines: essential steps in clinical trial design

ABSTRACT

A vaccine clinical trial is a research study in humans which aims to investigate or confirm the clinical, pharmacological, or immunological effects of a vaccine to establish the vaccine’s safety and/or efficacy. Once a promising vaccine candidate has been chosen from preclinical studies, it goes through a number of phases of clinical trials in humans before and after licensure. Ensuring the trial is designed correctly to answer the specific question(s) or objective(s) is of primary importance. In addition, the clinical trial must be conducted according to the principles of good clinical practice (GCP). The primary tenants of GCP are minimizing risk to the participant, safeguarding participants, informed consent, adhering to an approved research protocol, and ensuring data integrity. This chapter outlines how to plan and run a clinical vaccine trial including the principles and application of GCP, trial design, documentation, regulatory requirements, data quality, and safety considerations. © 2022 Elsevier Inc. All rights reserved.