The European Medicines Agency (EMA) published an updated Guideline on clinical evaluation of vaccines (EMEA/CHMP/VWP/164653/05 Rev. 1). This guideline was updated following EMA's experience in the past decade with new vaccines applications, including the approval of the COVID-19 vaccines.
These applications have raised several issues for vaccine clinical development programmes that were not addressed in the previous guideline. EMA also encountered requests for scientific advice on vaccine clinical development programmes that have pointed to the need to provide updated or additional guidance on some issues. For example, on considerations for conducting vaccine efficacy trials,
identification of immune correlates of protection, vaccines intended to be used in heterologous prime-boost regimens and vaccines to be administered to pregnant women to protect their infants during the first months of life.
The updated guideline also clarifies the role Human Challenge Trials (HCT) or Controlled Human Infection Models (CHIM) can play in the development of vaccines. Next to the use as proof-of-concept (PoC) trial in early clinical development, it particularly highlights the possibility of using a Human Challenge Trial to support vaccine development in a number of cases like:
The guideline also offers the possibility to use HCT to assist in dose and/or regimen selection.
Recent examples of the use of HCT in vaccine development are:
WHO pre-qualification of Typbar-TCV, a typhoid conjugate vaccine based on immunogenicity studies and the data on efficacy from the human challenge study
Marketing Authorisation of Vaxchora a live oral cholera vaccine intended to prevent cholera disease in travellers based on a HCT as pivotal efficacy trial.
PRIME and Breakthrough designation of the Bavarian Nordic RSV vaccine based on immunogenicity and HCT
Discussions with regulators in an early stage of development are paramount in order to speed up development to ensure the most appropriate development route is chosen.
View the EMA guideline: https://www.ema.europa.eu/en/documents/scientific-guideline/
guideline-clinical-evaluation-vaccines-revision-1_en.pdf
Learn more about our integrated solution for on human challenge studies.