Valneva Announces Start of Phase II Clinical Trial of its Clostridium difficile vaccine candidate
Valneva SE announced the initiation of the Phase II clinical trial of its VLA84 prophylactic vaccine candidate against Clostridium difficile (C. difficile), the main cause of nosocomial diarrhea. Data from the Phase I study in healthy elderly and adults showed good safety and immunogenicity of the vaccine candidate, and indicated functionality of induced antibodies, supporting the Company’s decision to progress the vaccine candidate into Phase II.
The Phase II study (VLA84-201) will enroll 500 healthy subjects aged 50 years and older. This age group represents the target population for a prophylactic C. difficile vaccine as the risk to contract the infection-associated disease increases with age. The randomized, placebo-controlled, observer-blind study will be conducted in Germany as well as in the United States under an Investigational New Drug application (IND). It aims to confirm the optimal dose and formulation of the vaccine in two different age groups and to generate sufficient additional clinical data to advance the program into Phase III.
Valneva expects to announce the first results of the Phase II study at the end of 2015.
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