The Celldex ETEC Vaccine is an oral vaccine candidate for protection against both Enterotoxogenic E. Coli and Vibrio cholerae infection, which are major causes of traveler’s diarrhea and significant causes of disease in children and elderly individuals in developing countries. The vaccine contains a live attenuated and genetically modified strain of Vibrio cholerae, expressing a plasmid-borne cholera toxin subunit B (CTB). This high-CTB expressing strain was derived from Peru-15 (CholeraGarde®), a live, attenuated V. cholerae El Tor Inaba strain that has been studied in Phase 1 and 2 clinical trials. There is strong clinical evidence that anti-cholera toxin antibodies provide cross-protection against heat-labile (LT) producing ETEC strains. The ETEC-cholera vaccine (Peru-15 pCTB) aims to take advantage of this cross- protection by maximizing anti-CT immune response through the administration of it’s high CTB expressing vaccine strain.
The ETEC-cholera vaccine is currently being studied in a Phase 1 trial sponsored by the Division of Microbiology and Infectious Diseases (DMID) of the National Institute of Allergy and Infectious Diseases (NIAID), an institute of the National Institutes of Health (NIH). The trial is a randomized double-blind, placebo-controlled, dose escalating trial in up to 64 healthy adult volunteers (aged 18 to 45, inclusive). The study will examine the safety and immunogenicity of a single dose of the ETEC-Cholera vaccine, at up to four escalating dose levels, compared against placebo. The Principal Investigator, Dr. Mitchell B. Cohen, M.D., will conduct the study at the Cincinnati Children's Hospital Medical Center.