The 160-subject study, part of an extensive Phase II program for the vaccine, measured the immune response to the vaccine patch, which is approximately the size and shape of an adhesive bandage. Four groups were evaluated: two groups received both doses of the vaccine from a medical professional and two other groups of volunteers administered the second vaccine patch themselves. All groups had robust responses to the vaccine, and a statistical analysis of immune parameters following vaccination showed no significant differences between treatment groups at any time point.
Iomai plans to conduct a Phase III efficacy study during summer of 2009, when the travelers’s diarrhea season in Latin America is at its peak. Based on the results of the self-application study, Iomai is evaluating the feasibility of including self-administration of the second vaccine dose in that Phase III study.
Stanley Erck, president and CEO of Iomai, said: “Our research has shown that self-application of the second dose further enhances the market potential of this product.”