Iomai has announced the completion of a Phase I/II clinical trial in which its dry vaccine patch for travelers' diarrhea achieved high immune responses in those vaccinated and outperformed its earlier liquid-based patch.
In this study, the company enrolled 160 subjects to compare its new dry patch formulation with its prior wet patch. One hundred subjects were dosed using a dry formulation and 60 subjects have been dosed using the prior wet formulation. The study was designed to determine whether immune responses after wearing the dry patch formulation were equal to those obtained with wet patches. Subjects were tested weekly for immune responses to enterotoxigenic E. coli (ETEC), the major cause of travelers' diarrhea. By the second week, the fold rise in antibodies to the ETEC antigen in the dry patch groups were significantly greater for all time points. In addition, dry patch recipients had greater than 95 percent seroconversion rates with one dose.