[Federal Register Volume 71, Number 244 (Wednesday, December 20, 2006)]
[Notices]
[Pages 76349-76350]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-21666]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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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: 301/496-7057; fax: 301/402-0220. 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; 
[email protected].
    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 
[mu]g 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

[[Page 76350]]

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; 
[email protected].
    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, [email protected] 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.
[FR Doc. E6-21666 Filed 12-19-06; 8:45 am]
BILLING CODE 4140-01-P