Accelerating the development of new vaccines for diarrhea

PATH is collaborating with private- and public-sector partners to speed the development of safe, effective, and affordable vaccines against the leading bacterial causes of diarrhea, Shigella and enterotoxigenic Escherichia coli (ETEC), for children in low-resource countries. By pursuing a wide range of promising vaccine approaches and related research, we aim to identify at least one vaccine candidate for each pathogen to prioritize for late-stage development.

ACE BioSciences

PATH is working with ACE BioSciences, a Danish biotechnology company, to support Phase 1 and 2 clinical trials of its ACE527 vaccine against ETEC. ACE527 is a live attenuated, whole cell, oral vaccine, which is comprised of three ETEC strains. We are also collaborating with ACE BioSciences on research to develop temperature stable, oral ETEC vaccine formulations. These spray- or freeze-dried vaccines would not require refrigerated storage and could support the routine, widespread vaccination of children in developing countries.

BioVentures for Global Health

PATH is collaborating with BioVentures for Global Health (BVGH) to conduct a business analysis of the market potential and financial models for ETEC vaccines to better inform potential manufacturers and to better understand supply and demand drivers for the development of these vaccines. We also plan to adapt this model to conduct an assessment of the Shigella vaccine market.

EndoBiologics, Inc.

PATH is working with EndoBiologics, Inc., in Missoula, Montana, to explore a novel method for producing conjugate vaccines, which could provide broader coverage at a lower price than conventionally produced conjugate vaccines. We are also evaluating new vaccination regimens that may provide more effective protection against Shigella.

Johns Hopkins University

PATH is partnering with Johns Hopkins University in Baltimore, Maryland, to conduct studies to refine an ETEC challenge model for assessing the protective efficacy of candidate vaccines. These studies should provide more information about protective immune responses and enable the use of a lower ETEC challenge dose in future clinical studies.

Tulane University

PATH has in-licensed the double mutant heat-labile toxin (dmLT) adjuvant, LTR192G/L211A, from Tulane University in New Orleans, Louisiana. An adjuvant is an ingredient that may enhance the effectiveness of some vaccines. This highly promising new adjuvant is also an ETEC antigen that may offer protection against disease.

University of Gothenburg

PATH is partnering with the University of Gothenburg in Sweden to evaluate an inactivated whole cell ETEC vaccine candidate, SBL 109. We are supporting both preclinical studies and proof of concept studies in humans to test for improved immunogenicity of SBL 109 compared to an earlier whole cell ETEC vaccine candidate.

University of Maryland, Baltimore

PATH is supporting early-stage clinical trials of the live attenuated CVD1208S Shigella vaccine candidate by the University of Maryland, Baltimore. This oral vaccine is ultimately envisioned to be a multivalent vaccine designed to prevent illness resulting from common disease-causing strains of the Shigella bacteria.

Walter Reed Army Institute of Research

PATH is collaborating with the Bioproduction Facility at Walter Reed Army Institute of Research in Silver Spring, Maryland, on the provision of antigens, vaccine and adjuvant pilot lots, and bacterial challenge organisms.