Product and trial design considerations on the path towards a vaccine to combat opioid overdose.

Abstract

Opioid overdose deaths are an evolving public health emergency in the United States. Recent advancements in drug conjugate vaccine design and adjuvantation technologies have re-ignited interest in the potential clinical utility of opioid vaccination. Here we present the concept of fentanyl vaccination as a complementary strategy for opioid overdose prevention with a focus on vaccine safety, efficacy, and considerations for vaccine development and testing in early phase human clinical trials.