Vaccine human clinical trial

Abstract

Globally incidence of infectious diseases has declined over the past decades, but still, they continue to have major public health and economic costs. Treatment of infectious diseases is complicated by patients’ late presentation at an advanced stage of their illness. Other challenges include high cost of treatment (drug and hospitalization) and increasing drug resistance. Because of this lack of effective, affordable, minimally toxic drug therapies, an effective vaccine to control infectious diseases is needed. The development of a prophylactic vaccine would prove to be the most effective strategy of disease control and one of the most cost-effective investments in the health sector. However, each newly developed vaccine needs to be evaluated for safety, immunogenicity, and prophylactic efficacy in humans before it is licensed for public use. In this book chapter, we discuss the key elements that should be considered to conduct the vaccine clinical trials against infectious diseases including COVID-19. © 2022 Elsevier Inc. All rights reserved.