Loading...
Date
Publisher
Frontiers Media SA
Abstract
The potential and positioning of controlled human infection models (CHIMs) and
human challenge trials (HCTs) in the investigation of infectious pathogens and
efficacy of new anti-infectives or vaccines are under evaluation. CHIMs and HCTs can
provide supporting data for decision-making in the development of new medicines
(“fast failure”). However, it is important to consider that, like in any phase 1 trial,
CHIM volunteers have no direct health benefit. Approval by an ethics or regulatory
board implies cautious evaluation of risk and potential safety issues. In this study,
we chose a syndromic approach to summarize CHIM and HCT adverse events (AEs).
AEs were grouped by disease entities, e.g., enteric, respiratory, vector-borne, and
parasitic infections. The analysis concludes that severe AEs are rare. It confirms that
AEs reflect symptoms of CHIM infections and are less prevalent in CHIM intended
for the induction of carriage. Furthermore, the number of subjects affected reflects
the attack rate and individual predisposition. Rarely, AEs affect the study participants’
daily activities, ranging from impairing and preventing routine tasks to requiring
emergency room visits or hospitalizations. Nevertheless, while AEs guide ethical
and regulatory considerations, symptoms are needed as endpoints for evaluation
of the efficacy of drugs or vaccines. Finally, we observe a lack of harmonization
in the reporting and grading of AEs. This reveals an eminent need for a reporting
structure that allows accessibility and comparability of data sets.
Metadata
Philipps-Universität Marburg
License
Except where otherwised noted, this item's license is described as Attribution 4.0 International