Intercell starts the second part of a Phase I clinical trial with vaccine candidate to prevent Clostridium difficile infections
Trial in vaccine target group of elderly subjects (elderly >65 years) initiated
Intercell AG announced the start of the second half of a Phase I clinical trial with the company's vaccine candidate IC84 to prevent disease caused by the bacterium Clostridium difficile (C. difficile).
First data from the Phase I study (Phase Ia) in a population of healthy adults aged 18-65 years showed good safety and immunogenicity of the vaccine candidate, and indicated functionality of induced antibodies in this study population. This supported the decision to carry forward the vaccine candidate for safety and dose-confirmation in the elderly.
The second part of the Phase I study (Phase Ib) will enroll 80 healthy elderly subjects above 65 years of age, as this age group represents the main target population for a C. difficile vaccine. Two vaccine concentrations will be tested with and without alum to confirm the vaccine dose and necessity of the adjuvant in the elderly. Compared to the Phase Ia part of the study in healthy young adults, the vaccination schedule has been modified to potentially optimize the immune response in elderly subjects who might respond differently to the vaccination due to their immunosenescence.
Intercell's vaccine candidate is a recombinant fusion protein consisting of two truncated toxins A and B from C. difficile. The toxins are known to be disease-causing and anti-toxin immunity can be protective.
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