• Nosocomial Infections

    Challenges in Vaccine Development

    Nosocomial Infections

    Challenges in Vaccine Development

    Speakers: Cliff McDonald (Centers for Disease Control and Prevention), Stuart Johnson (Loyola University Medical Center and Hines VA Hospital), Richard Novick (NYU School of Medicine), Jun F. (James) Liang (Stevens Institute of Technology), William C. Gruber (Pfizer Vaccine Clinical Research and Development), and Ginamarie Foglia (Sanofi Pasteur Inc.)
    Organizer: Michael Watson (Sanofi Pasteur)
    Presented by the Vaccine Science Discussion Group
    Posted May 4, 2010


    Nearly 100,000 patients die in the United States every year from infections acquired while in the hospital. The high incidence, increased severity, and burgeoning costs of these infections to the health care system have resulted in a growing interest in new vaccines and other preventative measures. Common bacterial pathogens in the clinical setting include Staphylococci, Enterococci, Clostridia, and Pseudomonas. Clinicians also see a high incidence of resistance to antibiotics, pathogenicity islands, and toxins in these settings. In particular, the spread of community-associated, methicillin-resistant Staphylococcus aureus (CA-MRSA) has increased concerns for public safety.

    On January 27, 2010, academic researchers, public health professionals, and pharmaceutical industry scientists gathered at the New York Academy of Sciences for the symposium "Nosocomial Infections: Challenges in Vaccine Development," to share up-to-date knowledge about current and emerging vaccines for nosocomial infections, focusing on the pathogenesis of select nosocomial bacteria. The speakers discussed host immunology, and lessons learned from vaccines already in use and those under development.

    The symposium began with a contextual introduction from Michael Watson (Sanofi Pasteur). Cliff McDonald (Centers for Disease Control and Prevention) then discussed the epidemiology of healthcare-associated infections (HAIs). At least 1.7 million HAIs occur in U.S. hospitals each year and additional infections and deaths occur in non-hospital settings. The majority of recognized HAIs are caused by bacterial pathogens that gain entry into the body following the use of invasive devices and surgical procedures. McDonald gave an overview of these infections, the pathogens responsible, risk factors for their occurrence, and the settings and patient populations most affected. Special focus was then given to the pathogens and infections with the greatest potential for prevention through vaccination. Focusing specifically on Clostridium difficile infection, Stuart Johnson (Loyola University Medical Center and Hines VA Hospital) presented a range of important considerations for vaccine development. Richard Novick (NYU School of Medicine) then took a closer look at the Staphylococcus pathogen.

    Jun F. (James) Liang (Stevens Institute of Technology) gave an update on biofilm and biofilm infections, covering new approaches to dealing with biofilm infections. Biofilms house over 95% of the bacteria existing in nature. They provide an ideal environment for bacterial attachment and colonization, and here bacteria remain protected, enabling them to evade host defenses and resist antibiotic treatment. Bacteria living in biofilms have been reported to exhibit up to 1000-fold greater resistance to antibiotics than planktonic bacteria, and are the cause of a wide range of human infections. Biofilm-associated nosocomial infections and diseases are currently the fourth leading cause of death in the U.S. (after heart disease, cancer, and stroke).

    William C. Gruber (Pfizer Vaccine Clinical Research and Development) then covered conjugate vaccines, and gave an overview of lessons learned. Pneumococcal polysaccharide CRM197 vaccines have been successfully developed and have dramatically reduced community-acquired pneumococcal disease. This experience can be used to inform thinking about nosocomial vaccine antigens, target populations, regulatory approach, study endpoints, immunologic correlates of protection, and evaluation post-licensure. These features may be combined with strategies unique to nosocomial vaccine development to ensure a comprehensive approach.

    To end the symposium, Ginamarie Foglia (Sanofi Pasteur) discussed the challenge of Clostridium difficile infections (CDIs) for vaccines under development. Antibiotic therapy is a key risk factor for development of symptoms associated with CDI, yet it is routinely treated with antibiotics. Not surprisingly, there is much interest in the development of non-antibiotic interventions for CDI. This presentation described the rationale for a vaccine against CDI, the inherent challenges for developing such vaccines and the vaccination strategies currently being employed, then provided an overview of the lead active vaccine program in this important disease area.

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