Bruno Speder, VP of regulatory affairs & consultancy services, hVIVO, discusses how Human Challenge Trials (HCT) can be used in the framework of expedited review programs as part of drug and vaccine development.
Key insights:
- Human Challenge Trials can be used in a variety of ways, like dose-finding studies, in preparation for field trials, but the most common use is that HCTs are used as phase 2 proof-of-concept.
- HCTs are designed to provide early evidence about efficacy and determine if a drug is likely to be successful in later clinical trial phases.
- A number of RSV vaccines currently under development, including the J&J, Pfizer and Bavarian Nordic vaccines, received breakthrough and/or PRIME designation based on preliminary clinical evidence collected in a Human Challenge Trial.
- The efficacy data is collected in a well-defined model, without the ‘noise’ of a field trial. This allows the collection of ‘crisp’ data while being able to focus on the required clinical outcomes.
hVIVO plc (formerly Open Orphan plc) is a rapidly growing specialist contract research organisation (CRO) and the world leader in testing infectious and respiratory disease vaccines and antivirals using human challenge clinical trials, providing end-to-end early clinical development services for its broad and long-standing client base of biopharma companies.
