This randomized, double-blind, placebo-controlled, single-dose, dose-escalation trial is being conducted in healthy adults. The company anticipates that trial results will be available by end of 2008. This US study will evaluate vaccine manufactured at the large-scale facility planned for commercial launch.
This trial is designed to confirm the safety and immunogenicity of the vaccine, and Phase III trials are expected to begin in 2009. If approved, this candidate would be the first single-dose, drinkable typhoid vaccine available for adults and children, the company said.
Daniel Abdun-Nabi, president and COO of Emergent BioSolutions, said: “In previous clinical studies, this vaccine candidate has demonstrated promising immunogenicity and safety results in both children and adults. We are pleased with our continued progress in the development of this important vaccine candidate, which is a cornerstone in our company’s mission of protecting life.”