The field test will provide the investigators with the crucial information needed to launch a phase III trial of the needle-free vaccine.
The placebo-controlled study is designed to assess the safety of the vaccine and the frequency of enterotoxigenic E. coli (ETEC) infection in volunteers traveling to sites where the disease is endemic and offer other details that will be key for the coming phase III trial.
Most cases of travelers’ diarrhea are caused by ETEC, and as many as 50% of travelers to areas where the bacteria is endemic are sickened over a one- to two-week period. No ETEC vaccine is available in the US.
“The phase II field test sets the groundwork for our pivotal trial of the travelers’ diarrhea vaccine, which may offer advanced, needle-free protection from a common bacterial infection,” said Stanley Erck, president and CEO of Iomai. “This study is part of a comprehensive phase II development program also designed to assess the ideal dose and formulation of the patch, as well as gather data on how the vaccine patch can be applied.”