NIH Initiates Phase I Study of Avant’s Oral Combination Vaccine

Avant Immunotherapeutics has announced that the division of microbiology and infectious diseases of the National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, has initiated a Phase I safety study of the company’s investigational single-dose, oral vaccine designed to offer combined protection against both enterotoxigenic Escherichia coli and cholera.

The study, a randomized double-blind, placebo-controlled, in-patient Phase I trial conducted in up to 64 adult volunteers, will examine the safety and immunogenicity of a single dose of the Escherichia coli (ETEC)-cholera vaccine, designated Peru-15 pCTB, at up to four escalating dose levels compared against placebo.

Anthony Marucci, interim president and CEO of Avant, said: “This vaccine builds on the clinical successes to date of our single-dose, oral typhoid fever and cholera vaccines, and represents the next important milestone towards our goal of developing a safe, oral, rapid-acting ‘super enteric’ vaccine that combines protection against multiple diseases in a single product.”