Lipopolysaccharide Vaccine for Treatment of Sepsis and Protection Against Infections by Gram-negative Bacteria (Case 2312)

Principal Investigators:

Steven Opal, MD, Professor
Department of Bio Med Medicine
Brown University
Rhode Island Hospital
Providence, RI

Alan Cross, MD, Professor
Division of Geographic Medicine
University of Maryland
Baltimore, MD

Brief Description:

Overview

The present technology, created by academic and federal research collaborators, relates to a novel vaccine and its use in humans for the prevention of sepsis and protection against infection with a wide variety of Gram-negative bacteria. The vaccine comprises detoxified core lipopolysaccharide from Escherichia coli J5 complexed with group B meningococcal outer membrane protein. A Phase 1 clinical trial showed the vaccine to be safe and immunogenic. Efficacy of the vaccine has been further improved by including CpG oligodeoxynucleotide as adjuvant. This vaccine shows great promise as both a prophylactic and therapeutic approach for control of infections by Gram-negative bacteria, including biological warfare agents.

Applications

-Vaccine against sepsis with broad protection.
-Antibodies raised from the vaccine may be used for passive immunization of infected individuals and in rapid response to biological warfare.
-Vaccine may be given to prevent lethal complications in heat-related injury and graft-versus-host disease.
-Vaccine may be used to protect individuals who work in high-risk professions (e.g., policemen, firemen, military.

Advantages

-Provides broad protection against lethal infections caused by heterologous gram-negative bacteria (such as Klebsiella, Pseudomonas, Burkholderia, Francisella, Yersinia, Enterobacter, E.coli, Serratia, Actinobactersp, Salmonella, or Shigella).
-Human clinical trials have validated the safety and efficacy of the vaccine.
-Vaccine development does not require complex preparations and requires no special containment facilities.

Stage of Development

Phase 1 clinical trials have validated the safety and efficacy of the vaccine in humans. The addition of CpG to the vaccine was shown to markedly increase the antibody response in the neutropenic rat model of sepsis, and a further Phase 1 clinical trial will soon test the vaccine in conjunction with CpG adjuvant. Additional studies are in progress to investigate the vaccine's protection against a variety of Gram-negative organisms.

Additional Information:

US patent application 14/636,951 is pending.

Patent Information:
For Information, Contact:
Margaret Shabashevich,
Manager of Operations
Technology Ventures Office
Brown University
401-863-7499 TVO_Patents@brown.edu
Inventors:
Steven Opal
Alan Cross
Apurba Bhattacharjee
Wendell Zollinger
Keywords:
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