Advanced development and clinical evaluation of a synthetic intranasal Entamoeba histolytica vaccine containing adjuvant

This project proposes to optimize, manufacture, and clinically evaluate an intranasally delivered prophylactic Entamoeba histolytica vaccine (NIAID Category B pathogen) containing adjuvant. The proposed vaccine consists of a synthetic recombinant protein antigen (LecA) and a synthetic dual TLR ligand adjuvant formulation (GLA-3M052 liposomes) administered by nasal spray. The scope of work is designed to optimize dose and excipient composition and intranasal administration of the candidate product in preclinical models followed by cGMP manufacture and a Phase 1 clinical trial. By implementing critical product enhancement strategies and cutting edge adjuvant technology early in development, a vaccine against the enteric Category B pathogen E. histolytica will be developed that is able to overcome many of the challenges associated with traditional enteric vaccine approaches. In particular, we will seek to establish the safety and immunogenicity of intranasal delivery of a recombinant antigen-based vaccine containing a synthetic adjuvant formulation.