Intercell starts a Phase I clinical trial for a new vaccine to prevent Clostridium difficile infections
Intercellʹs vaccine candidate is a recombinant protein vaccine consisting of two truncated toxins A and B from Clostridium difficile. The toxins are known to be disease‐causing and antitoxin immunity can be protective. The vaccine candidate will be tested with or without the adjuvant aluminum hydroxide.
This Phase I trial is a first‐in‐man study to obtain safety and immunogenicity data in a small population of healthy adults aged 18‐65 years in the first part of the study as well as from healthy elderly subjects above 65 years of age in a second part of the study, the latter age group representing the main target population for a Clostridium difficile vaccine. 60 healthy adults and up to 100 elderly subjects will be enrolled in this open‐label study. Three different alum‐adjuvanted vaccine concentrations will be tested; two of the three vaccine concentrations will also be tested without adjuvant.
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