Safety and reactogenicity of a controlled human infection model of sand fly-transmitted cutaneous leishmaniasis

The preprint operates within the established paradigm of using Controlled Human Infection Models (CHIMs) for vaccine development and understanding disease pathology. This paradigm accepts the controlled infection of human volunteers as an ethical and scientifically valuable tool for advancing medical knowledge.

This research firmly falls within the category of normal science. It utilizes the accepted CHIM paradigm to address specific research questions regarding the safety, reactogenicity, and immunological responses associated with a sand fly-transmitted cutaneous leishmaniasis (CL) model. The study aims to refine the existing CHIM by optimizing procedures for lesion size and scarring, contributing to the ongoing development and improvement of the model within the existing paradigm. It does not challenge fundamental assumptions or propose radical new theories but works within the established framework to gather data and improve the existing model's utility. While the research provides valuable insights into the immune landscape of CL, it does not constitute a paradigm shift or model revolution. The work represents a meticulous application of established methods within the accepted paradigm, demonstrating the characteristics of normal science as defined by Kuhn.