E6-21666. Government-Owned Inventions; Availability for Licensing

AGENCY:

National Institutes of Health, Public Health Service, HHS.

ACTION:

Notice.

SUMMARY:

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

ADDRESSES:

Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: [phone]; fax: [phone]. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.

A Method of Immunizing Humans Against Salmonella Typhi Using a Vi-rEPA Conjugate Vaccine

Description of Technology: This invention is a method of immunization against typhoid fever using a conjugate vaccine comprising the capsular polysaccharide of Salmonella typhi, Vi, conjugated through an adipic dihydrazide linker to nontoxic recombinant exoprotein A (rEPA) from Pseudomonas aeruginosa. The three licensed vaccines against typhoid fever, attenuated S. typhi Ty21a, killed whole cell vaccines and Vi polysaccharide, have limited efficacy, in particular for children under 5 years of age, which make an improved vaccine desirable.

It is generally recognized that an effective vaccine against Salmonella typhi is one that increases serum anti-Vi IgG eight-fold six weeks after immunization. The conjugate vaccine of the invention increases anti-Vi IgG, 48-fold, 252-fold and 400-fold in adults, in 5-14 years old and 2-4 years old children, respectively. Thus this is a highly effective vaccine suitable for children and should find utility in endemic regions and as a traveler's vaccine. The route of administration can also be combined with routine immunization. In 2-5 years old, the protection against typhoid fever is 90% for 4 years. In school age children and in adults the protection could mount to completer protection according to the immunogenicity data.

Application: Immunization against Salmonella typhi for long term prevention of typhoid fever in all ages.

Developmental Status: Conjugates have been synthesized and clinical studies have been performed. The synthesis of the conjugates is described by Kossaczka et al. in Infect Immun. 1997 June;65(7):2088-2093. Phase III clinical studies are described by Mai et al. in N Engl J Med. 2003 October 2; 349(14):1390-1391. Dosage studies are described by Canh et al. in Infect Immun. 2004 Nov;72(11):6586-6588.

A safety and immunogenicity study in infants are underway. The aim is to administer the conjugate vaccine with routine infant immunization. Preliminary results shows the vaccine is safe in 2 months old infants.

Inventors: Zuzana Kossaczka, Shousun C. Szu, and John B. Robbins (NICHD).

Patent Status: U.S. Patent 6,797,275 issued 28 Sep 2004 (HHS Reference No. E-020-1999/0-US-02); U.S. Patent Application No. 10/866,343 filed 10 Jun 2004 (HHS Reference No. E-020-1999/0-US-03).

Licensing Status: Available for non-exclusive licensing.

Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; [e-mail].

Collaborative Research Opportunity: The National Institute of Child Health and Human Development, Laboratory of Developmental and Molecular Immunity, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize A Method of Immunizing Humans Against Salmonella Typhi Using a Vi-rEPA Conjugate Vaccine. Please contact Betty Tong, PhD at 301-594-4263 for more information.

Vaccine Against Escherichia Coli O157 Infection, Composed of Detoxified LPS Conjugated to Proteins

Description of Technology: This invention is a conjugate vaccine to prevent infection by E. coli O157:H7, particularly in young children under 5 years of age. E. coli O157:H7 is an emerging human pathogen which causes a spectrum of illnesses with high morbidity and mortality, ranging from diarrhea to hemorrhagic colitis and hemolytic-uremic syndrome (HUS). Infection with E. coli O157:H7 occurs as a result of consumption of water, vegetables, fruits or meat contaminated by feces from infected animals, such as cattle. The most recent large outbreak in the U.S. was from contaminated bag spinach. The conjugate is composed of the O-specific polysaccharide isolated from E. coli O157, or other Shiga-toxin producing bacteria, conjugated to carrier proteins, such as non-toxic P. aeruginosa exotoxin A or Shiga toxin 1. A Phase I clinical trial, involving adult humans, showed the vaccine is safe and highly immunogenic. Adults, after one injection containing 25 μg of antigen, responded with high titers of bactericidal antibodies. Similarly in a phase II study, fifty 2 to 5 years-old children in U.S. were injected with the conjugate vaccines. There were only mild local adverse reactions. More than 90% children responded with greater than 10 fold rise of E. coli O157 antibodies of bactericidal ability. Thus the conjugates of the invention are promising vaccines, especially for children and the elderly, who are most likely to suffer serious consequences from infection.

Application: Prevention of E. coli O157 infection.

Development Status: Clinical studies have been performed and are described in Konadu et al., J Infect Dis. 1998 Feb;177(2):383-387 and Ahmed et al., J Infect Dis. 2006 Feb;193(2):515-526.

Inventors: Shousun C. Szu, Edward Konadu, and John B. Robbins (NICHD).

Patent Status: U.S. Patent 6,858,211 issued 22 Feb 2005 (HHS Reference No. E-158-1998/0-US-06); U.S. Patent Application No. 10/987,428 filed 12 Nov 2004 (HHS Reference No. E-158-1998/0-US-07).

Licensing Status: Available for non-exclusive or exclusive licensing.

Licensing Contact: Peter A. Soukas, J.D.; 301/435-4646; [e-mail].

Collaborative Research Opportunity: The National Institute of Child Health and Human Development, Laboratory of Developmental and Molecular Immunity, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize Vaccine for E. coli O157 for Children and Adults. Please contact Betty Tong, PhD at 301-594-4263, [e-mail] for more information.

Dated: December 8, 2006.

Steven M. Ferguson,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.