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news.Avant Immunotherapeutics said that a division of the National Institutes of Health will sponsor a Phase I study of Avant's investigational single-dose, oral vaccine designed to offer combined protection against both enterotoxigenic Escherichia coli and cholera.
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The study will be sponsored by the Division of Microbiology and Infectious Diseases of the National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health. The Phase I trial, conducted in up to 64 adult volunteers, will examine the safety and immunogenicity of a single dose of the enterotoxigenic Escherichia coli (ETEC)-cholera vaccine, designated Peru-15 pCTB, at up to four escalating dose levels compared against placebo.
ETEC is a major cause of enteric disease among travelers, military personnel and those who live in developing countries where the disease is endemic. The study will be conducted at the Cincinnati Children’s Hospital Medical Center and is planned to begin in early 2008.
Una Ryan, Avant president and CEO, said: “We are very pleased that National Institute of Allergy and Infectious Diseases has chosen to fund this initial study of our combination ETEC-cholera vaccine. This vaccine builds on the clinical successes to date of our single-dose, oral cholera vaccine, 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.”