Intercell announces initial results of Phase II clinical trial evaluating V710, an investigational Staphylococcus aureus vaccine
Primary Immunogenicity and Safety objectives met
Intercell AG announced top-line results from a Phase II clinical trial of V710, an investigational vaccine for the prevention of Staphylococcus aureus (S. aureus) infections. The study, conducted by Intercell's collaborator, a subsidiary of Merck & Co., Inc, was designed to evaluate the safety and immunogenicity of V710 in patients with end-stage renal disease (ESRD) undergoing hemodialysis treatment.
In the randomized double blind, placebo controlled study 201 patients received vaccine or placebo at 12 centers in the U.S. The study was designed to assess whether administration of V710 to ESRD patients receiving hemodialysis at high risk of developing serious S. aureus infections could increase the level of antibodies to the V710 antigen. 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. Overall 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.
Overall, 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. There were no vaccine-related serious adverse experiences reported throughout the study duration (Days 1 to 360), and no patients discontinued the study or subsequent vaccinations due to a vaccine-related adverse experience.
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Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous
Topic world Antibodies
Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous