A Phase 2 clinical trial for Pfizer's Clostridium difficile vaccine candidate produced positive results, according to an announcement from the pharmaceutical company on Thursday.
The randomized study examined the vaccine's ability to generate an immune response in 850 healthy adults aged 65 to 85 years. The study also tested the vaccine's safety and tolerability. A Phase 3 trial for the vaccine is expected to commence in the first quarter of 2017.
"Despite improved infection control measures, C. diff disease continues to rise, further augmenting an already urgent public health threat with particular negative impact on older adults," said Kathrin Jansen, PhD, senior vice president and head of vaccine research and development for Pfizer. "We are very encouraged by these interim immunogenicity and safety results demonstrating robust increases in vaccine-elicited neutralizing antibodies to both toxins that we believe could provide protection against C. diff disease."
C. diff was linked to nearly 500,000 infections in the United States in 2011, according to the CDC. Approximately 29,000 of those infected died within 30 days of diagnosis.
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