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news.Emergent BioSolutions has received positive results from a phase II clinical study evaluating a new simplified dosing regimen for the company's next generation single dose oral vaccine for typhoid.
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The phase II study, conducted under a company-sponsored IND led by Dr Beth Kirkpatrick at the University of Vermont, evaluated the safety and immunogenicity of the vaccine in 32 healthy adult volunteers.
The study demonstrated that utilization of a simpler more rapid dosing regimen did not affect the excellent safety profile or the magnitude of the immune response stimulated by the vaccine.
Commenting on the results, Dr Beth Kirkpatrick said, “We think this oral, single dose freeze-dried vaccine, which was simple to administer, is showing great promise providing an excellent basis on which to advance further clinical development. A single oral-dose typhoid vaccine which is simple to administer would facilitate vaccination in all populations, including travelers to, and residents living in areas where typhoid fever is endemic or epidemic.”
Emergent is planning to evaluate its oral typhoid vaccine further in phase II studies in Vietnam with financial support from the Wellcome Trust prior to starting phase III studies.
A significant number of cases of typhoid are reported in both Europe and US most of which are contracted while abroad with an estimated global incidence of 30 million cases and 600,000 mortalities, worldwide every year.