PATH, NIAID to conduct Phase 1 trial of adjuvant

PATH, an international nonprofit global health organization, recently signed an agreement with the Division of Microbiology and Infectious Diseases at the National Institutes of Allergy and Infectious Diseases in Bethesda, Md., to conduct a Phase 1 clinical trial of the double mutant heat-labile toxin (dmLT) vaccine/adjuvant.

The dmLT, a new vaccine/adjuvant that PATH in-licensed from Tulane University, is also an ETEC (Enterotoxigenic E. coli) antigen that may offer protection against disease.

Enterotoxigenic E. coli strains are one of the most common causes of bacterial diarrhea.

The trial is expected to begin by mid-2010.

PATH also recently signed an agreement with the Walter Reed Army Institute of Research in Silver Spring, Md., to develop an inactivated shigella whole-cell vaccine candidate. The partnership will include manufacturing of the vaccine candidate, as well as characterization through preclinical animal studies to prepare for human clinical trials.

The candidate will be tested both alone and in conjunction with the dmLT vaccine/adjuvant.