Manuscript title: Cytokines Associated With Moderate and Severe Adverse Events During a Sporozoite Malaria Vaccine Trial with Controlled Human Malaria Infection.

Abstract

Ensuring the safety and efficacy of candidate vaccines is critical. Although mechanisms underpinning protective immune responses to malaria vaccines are frequently investigated, immune responses correlating with moderate and severe adverse events are rarely examined. Here, we leverage a malaria vaccine trial with a higher-than-expected adverse event rate and frequent sampling to investigate cytokine profiles associated with adverse events. We found that Interleukin-6 was elevated on days in which individuals experienced moderate and severe adverse events. More research on immune responses associated with adverse events is warranted in order to identify biomarkers associated with systemic reactogenicity and accelerate vaccine development.