Valneva SE, a biotechnology company based in Europe, recently started Phase II clinical trial of its VLA84-201 prophylactic vaccine treatment for Clostridium difficile, a bacteria that is notoriously difficult to treat.
Also known as C. difficile, Clostridium difficile is a key cause of nosocomial diarrhea and results in approximately 14,000 deaths every year in the United States.
No vaccine currently exists to fight C. difficile. Researchers hope this study will mark a turning point in battling the bacteria.
The study involves 500 healthy subjects in Germany and the United States. All are 50 years old or older, which is the age group most commonly and severely affected by C. difficile.
Phase I testing of VLA84-201 found that the vaccine showed promising results in healthy adults and the elderly. It was safe and induced antibodies were functional.
The goal of the Phase II study is to determine the best formulation of the vaccine and the best dosage for two different age groups of individuals. Researchers hope to discover enough positive data to continue the trial into Phase III.
The study’s initial results should become clear in the first quarter of 2015.