BELLEROPHON

Combining Cellular and Humoral Immune Responses as a Vaccine Strategy against Staphylococcus aureus Pathogen

Background

The bacterium Staphylococcus (S.) aureus causes a range of serious infections in humans.  It is responsible for approximately 16,000 deaths annually in Europe and 19,000 in the US. Additional studies suggest at least €380 million annual European costs are attributable to S. aureus, as well as several billion US$ per annum in the US.  The emergence of highly antibiotic resistant S. aureus strains, such as Methicillin-resistant S. Aureus  (MRSA), are creating a serious global public health threat, which is an increasing economic burden.  As recent vaccine candidates have not proven effective in large human clinical studies, there continues to be a severe medical need.

The pan-European BELLEROPHON project comprises four European institutions involved in vaccine development, each contributing specialist expertise and technology: IMAXIO, a French biotech company focused on immunology, and coordinator of the grant application, and the Jenner Institute at University of Oxford (UOXF), UK, an academic institution with key expertise in S. aureus antigens and viral vector delivery systems, who is coordinating the overall project.  Another partner, EVI is assisting with project management tasks and advising on production and the clinical aspects of the project.  The fourth member is Preclin Biosystems, a Swiss contract research organisation with strong expertise in preclinical efficacy models for infectious diseases.

Objectives

S. aureus, including MRSA, is one of the most important bacterial pathogens, causing skin lesions, and deep infections in both the community and in hospitals.  Treatment is difficult and expensive and may require prolonged intravenous antibiotic therapy.  Since there is no vaccine licensed by the US Food and Drug Administration (FDA) or European Medicines Agency (EMA), interception also relies heavily on antimicrobials to which antibiotic resistance is developing.  To reduce S. aureus disease burden, and antibiotic use associated with it, BELLEROPHON will design, manufacture, and assess in a phase I clinical trial a novel S. aureus vaccine candidate targeting both the cellular and humoral responses.  It is designed to protect against both MRSA and more sensitive S. aureus strains.

 

Major Milestones

Administrative:

  • The Grant Agreement was signed in May 2013.  The Consortium Agreement was signed April 2013.  
  • The kick-off meeting was held on 12/13 September 2013 hosted by the coordinator UOXF in Oxford, UK.

Publications

Vaccine. 2016 Apr 4;34(15):1792-9. doi: 10.1016/j.vaccine.2016.02.034. Epub 2016 Feb 26