Intercell has reported positive Phase II clinical trial results of V710, an investigational vaccine for the prevention of Staphylococcus aureus infections.
The randomised, double-blind and placebo-controlled study evaluated the safety and immunogenicity of V710 in patients with end-stage renal disease who were receiving haemodialysis treatment.
The study involved 201 patients with the condition, who were randomised to receive either vaccine or placebo.
The primary endpoints of the study were changes in antibody levels compared to baseline at 28 days after a two-dose regimen of the vaccine given 28 days apart, and all adverse events for 14 days after vaccination.
The immunogenicity data revealed that V710 can bring about a sustained immune response in a relatively immunocompromised patient population who are at chronic risk of developing serious S. aureus infections.
Results of safety evaluation showed that V710 was generally well tolerated. No vaccine-related serious adverse experiences reported throughout the study duration.