The phase I trial is a dose escalating trial in which volunteers will receive three monthly intramuscular doses of vaccine. The trial is designed to confirm that the vaccine is safe at doses that induce ricin neutralizing antibodies.
As part of the phase I clinical trial, if sufficient immunogenicity is achieved in humans, DOR intends to isolate ricin specific antibodies from the human volunteers and transfer them to animal models to test the human antibodies’ effectiveness in protecting the animals from ricin toxin exposure.
“This phase I clinical trial represents an important milestone for DOR and our collaborators as we move assertively to develop vaccines against known bioterrorism threats,” commented Michael Sember, president and CEO of DOR.
The company expects that preliminary interim safety and immunogenicity data will be available as early as the second quarter of 2005.