The study, conducted by Intercell’s collaborator, a subsidiary of Merck, was designed to evaluate the safety and immunogenicity of V710 in patients with end-stage renal disease (ESRD) undergoing hemodialysis treatment.
In the Phase II randomised double blind, placebo controlled study patients received vaccine or placebo at 12 centers in the US.
V710 Phase II study was designed to assess whether administration of the drug to ESRD patients receiving hemodialysis at high risk of developing serious S aureus infections could increase the level of antibodies to the V710 antigen.
Intercell said that the primary endpoints of the study were the change of antibody levels compared to baseline at 28 days after a 2-dose regimen provided 28 days apart and all adverse experiences for 14 days after each vaccination.
Reportedly, the immunogenicity data suggest that V710 can elicit a sustained immune response in a relatively immunocompromised patient population who are at chronic risk for developing serious S aureus infections.
Additionally, the results of the safety evaluations demonstrated that V710 was generally well tolerated when administered as a single- or multiple-dose regimen at any dosage group studied.
Intercell CEO Gerd Zettlmeissl said that it was encouraging to see that the S aureus vaccine has proven immunogenic and was generally well tolerated in ESRD patients receiving hemodialysis.
"We are looking forward to the continued progress of the S aureus program at our strategic partner Merck," Zettlmeissl said.
Intercell said that the S aureus vaccine candidate is based on a conserved protein antigen discovered by the company and licensed to Merck 2004 on an exclusive world wide basis.
Merck will be responsible for clinical development, manufacturing and marketing, while Intercell is eligible to receive milestone payments and royalties on future net sales.