Human challenge trials in vaccine development.

The increasing recent interest in human challenge studies or controlled human infection model studies for accelerating vaccine development has been driven by the recognition of the unique ability of these studies to contribute to the understanding of response to infection and the performance of vaccines. With streamlining of ethical processes, conduct and supervision and the availability of new investigative tools from immunophenotyping to glycobiology, the potential to derive valuable data to inform vaccine testing and development has never been greater. However, issues of availability and standardization of challenge strains, conduct of studies in disease endemic locations and the iteration between clinical and laboratory studies still need to be addressed to gain maximal value for vaccine development.

SARS-CoV-2 controlled human infection models: Ethics, challenge agent production and regulatory issues.

This second International Alliance for Biological Standardization COVID-19 webinar brought together a broad range of international stakeholders, including academia, regulators, funders and industry, with a considerable participation from low- and middle-income countries, to discuss the use of controlled human infection models to accelerate development and market authorization assessment of a vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).