This new trial is intended to evaluate the safety and immunogenicity of an improved formulation of the vaccine containing an adjuvant that is expected to result in long lasting and high levels of protective antibodies. The new trial is being conducted as part of a program funded by a grant from the orphan products division of the FDA.
The new trial employs an escalating dose strategy in which volunteers receive three intramuscular doses of vaccine at six-week intervals, matching many commonly employed vaccination regimens.
The trial is designed to confirm that, in conjunction with the adjuvant, the vaccine is safe at doses that induce protective antibodies, and that an adjuvanted formulation results in sustained and higher titer antibodies. Safety and immunogenicity data is anticipated in the first half of 2009.
Robert Brey, chief scientific officer of Dor, said: “We have been encouraged by the safety and animal efficacy results to date, and combined with our accruing stability data, we are poised to carry out expanded Phase II human trials in the next six to nine months.”