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C. difficile Vaccine Enters Phase 3 Trial
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An investigational vaccine for the prevention of Clostridium difficile infection will be evaluated in a phase 3 trial this year after showing promise in phase 2 development, according to a press release.
The PF-06425090 vaccine (Pfizer) is designed to induce a functional antibody response that neutralizes two disease-causing toxins produced by C. difficile known as toxin A and toxin B. The FDA granted the vaccine with Fast Track designation in August 2014 to facilitate its development and accelerate the review process.
A pre-planned interim analysis revealed positive phase 2 data on the safety, tolerability and immunogenicity of the vaccine in more than 850 healthy adults aged 65 to 85 years, the release said. Researchers from the study evaluated two dose levels (100 µg and 200 µg) of the vaccine administered during two different three-dose vaccination schedules at 1, 8 and 30 days, or at baseline, 1 month and 6 months.
“Despite improved infection control measures, C. difficile disease continues to rise, further augmenting an already urgent public health threat with particular negative impact on older adults, Kathrin Jansen, PhD, senior vice president and head of Vaccine Research and Development for Pfizer, said in the release. “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. difficile disease.”
Disclosure: Jansen is an employee of Pfizer.