Emerging and Pandemic Pathogens: Lessons Learned From a Clinical Research Network.

Pathogens infecting humans continue to emerge or reemerge to cause outbreaks and widespread disease. The National Institute of Allergy and Infectious Diseases has funded Vaccine Treatment and Evaluation Units (VTEUs) for more than 50 years. VTEUs perform clinical studies to assess the safety and immunogenicity of candidate vaccines and other interventions to mitigate the impact of emerging and ongoing infectious diseases. Here, we review clinical studies conducted in the VTEUs since 2000 that have addressed emerging pathogens and other infectious agents with pandemic potential or of bioterrorism concern. The studies conducted range from phase 1 to phase 3 clinical trials, and they have included vaccines, therapeutics, and epidemiological studies. The results of the trials have guided national and often international recommendations for treatment and prevention of many of the evaluated pathogens, culminating in coronavirus disease 2019 studies that began within three months of severe acute respiratory syndrome coronavirus 2 identification. The VTEU network continues to be a critical public health resource for addressing emerging pathogens and expediting the development of safe and effective vaccines and treatments to protect at-risk populations.