An analysis of controlled human infection studies registered on ClinicalTrials.gov.

Objectives: Controlled human infection studies (CHIS) involve intentional exposure of human volunteers to infectious agents. A previous systematic review found that adverse event (AE) reporting across CHIS is inconsistent, which makes data aggregation and reuse difficult. We hypothesised that data may be more easily aggregated using a clinical trial registry such as ClinicalTrals.

A Systematic Review of Human Challenge Trials, Designs, and Safety.

Background: Few studies have assessed participant safety in human challenge trials (HCTs). Key questions regarding HCTs include how risky such trials have been, how often adverse events (AEs) and serious adverse events (SAEs) occur, and whether risk mitigation measures have been effective.

Methods: A systematic search of PubMed and PubMed Central for articles reporting on results of HCTs published between 1980 and 2021 was performed and completed by 7 October 2021.