Staphylococcus aureus vaccine
Our vaccine against Staphylococcus aureus (S. aureus) is being developed in cooperation with Merck & Co., Inc. on an exclusive, worldwide basis. Merck & Co., Inc. is responsible for clinical development, manufacturing and marketing. Intercell is eligible to receive milestone payments and royalties on future net sales.
The novel vaccine against S. aureus consists of a conserved protein antigen discovered by our proprietary Antigen Identification Program (AIP®). The vaccine candidate has shown to be highly protective in animal models and covers all subtypes of the bacterium including Methicillin-resistant Staphylococcus aureus (MRSA).
In a Phase I trial involving more than 120 adult healthy volunteers, the vaccine was found to be immunogenic, safe and generally well tolerated. Immune responses were observed within several weeks following single vaccination and persisted throughout the course of the study.
A Phase II clinical trial was initiated by Merck & Co., Inc. at the end of 2007 to evaluate the efficacy and safety of a single dose of the vaccine in patients undergoing elective cardiothoracic surgery. A further randomized, double-blind, placebo-controlled Phase II study started in August 2008. This follow up study is designed to assess the safety and immunogenicity of the vaccine candidate in patients with end-stage kidney disease who are receiving hemodialysis.
The study recruitment in the Phase II/III proof of concept clinical trial of an investigational Staphylococcus aureus vaccine (V710) is progressing. The first critical interim analysis (surpassing futility) are expected for 2010.
The most common cause of nosocomial infections
S. aureus is the most common cause of nosocomial, or hospital-acquired, infections and accounts for about 40 percent of all such cases. The bacterium is usually transmitted person to person and spreads through contact with secretion of infected skin lesions, nasal discharge or via the hands (Source CDC). Symptoms of S. aureus range from minor skin infections to serious or fatal infections of bloodstream, bone, heart and inner organs.
Hospital-acquired infections are one of the major causes of death and serious illness worldwide, resulting in an annual cost burden of more than USD 20 billion in the developed world. In the United States and Europe, about 4 million patients become infected annually resulting in 200,000 deaths per year. The incidence of nosocomial infections is steadily increasing due to medical interventions and antibiotic resistance.
Current treatment and prevention
Today, approximately half of all S. aureus strains isolated in hospitals worldwide are resistant to multiple antibiotics, rendering disease management difficult. What is more, there are no approved prophylactic vaccines.
In addition to a prophylactic vaccine, Intercell and Merck & Co., Inc. have entered a strategic alliance for the development of monoclonal antibodies for the treatment of severe S. aureus infections. The antigens have been detected by our AIP® , and Merck & Co., Inc. is responsible for subsequent pre-clinical and clinical development, registration and marketing of any products from the collaboration.
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Partners
- Merck & Co., Inc.