Acambis announces results from Phase 1 trial of C. difficile vaccine
Acambis plc announced results from a Phase 1 trial of its investigational vaccine against Clostridium difficile (C. difficile) in healthy adults.
Acambis' Phase 1 trial evaluated the safety, tolerability and immunogenicity of its C. difficile vaccine when administered at different dose levels. The randomised, double-blind, placebo-controlled study included a total of 50 healthy adult subjects: 37 subjects received Acambis' C. difficile vaccine and a control group of 13 subjects received placebo.
Antibody responses were seen in all subjects who received Acambis' vaccine. Four weeks after the first injection of the highest dose, anti-toxin A and anti-toxin B immunoglobulin G levels were at least 10-fold higher than those reported in another study of patients who had recovered from natural infection with C. difficile and did not suffer recurrent disease. Future efficacy trials will investigate the antibody levels produced by the vaccine that are needed for clinical protection against CDAD.
Vaccination at all dose levels was well tolerated in all subjects. The majority of side effects observed were those typical of vaccines injected intramuscularly. These reactions included mild tenderness, redness and pain at the injection site, and headache. No subjects experienced unexpected or serious vaccine-related adverse events.
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