Formulation of LbL microparticle vaccine in microneedle array for intradermal del

Abstract The ability of the immune system to recognize and initiate an immune response to foreign particles such as bacteria and viruses has generated interest in development of particulate vaccine technologies. We are developing an innovative approach toproduce particulate vaccines via layer-by-layer (LbL) fabrication of synthetic microparticles (MP). We have shown that LbL-MP loaded with epitopes from respiratory syncytial virus (RSV) or Plasmodium falciparum (Pf) elicit potent and balanced humoral and cellular immune responses that protect the immunized host from infection and disease following pathogen challenge. The LbL-MP vaccines are immunogenic and efficacious when administered at low doses (1-10 g) in aqueous suspension without any exogenous adjuvant, thus offering safety advantages over competing vaccine technologies. In this Phase I feasibility study, we will improve the LbL-MP technology by loading the MP into microneedle arrays designed to deliver the payload directly into the skin, a rich res