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Vaccine for Prevention of Sepsis and Broad Protection Against Gram-Negative Bacterial Infections

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Overview

The “J5dLPS/OMP” vaccine, created by academic and federal research collaborators led by Prof. Alan Cross, is a clinical-stage vaccine for the prevention of sepsis and protection against infection by 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 (“J5dLPS/OMP”). Phase 1 clinical trials showed the vaccine to be safe, well tolerated, and immunogenic. This vaccine shows great promise as both a prophylactic and therapeutic approach for control of many types of lethal infections by Gram-negative bacteria.

Applications

Sepsis is the leading cause of death in US hospitals (270,000 deaths/yr) and the most costly (> $24B/yr) 

o    J5dLPS/OMP vaccine provides broad protection against gram-negative bacterial infections (e.g., Klebsiella, Pseudomonas, Burkholderia, Francisella, Yersinia, Enterobacter, E.coli, Serratia, Actinobacter, Salmonella, Shigella)

o    Vaccine may prevent lethal complications from burn injuries, graft-versus-host disease, etc., and protect against biological warfare agents

o    Antibodies raised from vaccine may be used to treat infections and in rapid response to biological warfare

o    J5dLPS/OMP vaccine may be used to protect individuals who work in high-risk professions (e.g., military, police, and firefighters)

Vaccine also demonstrates potential for veterinary applications

 

Stage of Development

Two Phase 1 clinical trials, with & without CpG adjuvant, have validated the J5dLPS/OMP vaccine as safe, well tolerated, and immunogenic (Vaccine 2003 & 2015). The vaccine was effective in the neutropenic rat model of sepsis (eliciting a >200-fold increase in anti–J5 LPS antibody, and improving survival in immunized versus control animals: 61% versus 0% in Pseudomonas- and ceftazdime-treated rats; J. Inf. Disease 2001). Challenge studies in animal models demonstrated protection against lethal doses of F. tularensis (Vaccine 2010) and against lethal gram-negative bacillary pneumonia (Innate Immunity 2008). And, when cattle were immunized with the J5dLPS/OMP vaccine, high titers of serum anti-endotoxin antibodies were elicited, and were passed to the cow’s colostrum (Vaccine 2014).

Licensing Potential

UMB seeks development partner for licensing and/or sponsored research.

Contact Info

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