[Federal Register Volume 60, Number 25 (Tuesday, February 7, 1995)]
[Notices]
[Pages 7205-7206]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-2862]



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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, HHS.

ACTION: Notice.

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    The inventions listed below are owned by agencies 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. [[Page 7206]] Foreign 
patent applications are filed on selected inventions to extend market 
coverage for U.S. 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 Robert Benson 
at the Office of Technology Transfer, National Institutes of Health, 
6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804 
(telephone 301/496-7735 ext 267; fax 301/402-0220). A signed 
Confidential Disclosure Agreement will be required to receive copies of 
the patent applications.

Polysaccharide-Protein Conjugates

    Shouson Szu, Rachel Schneerson, and John B. Robbins (NICHD), Serial 
No. 07/155,799, Patent Issued 20 Apr 93, U.S. Patent Number 5,204,098.
    The invention concerns conjugates of pathogenic microorganism 
capsular polysaccharides and proteins useful as vaccines. The broadest 
claim reads: ``A composition for enhancing the antibody response of a 
host comprising a capsular polysaccharide having carboxyl groups 
conjugated through a thio derivative of said carboxyl groups to a 
protein in a physiologically acceptable carrier.'' Applications are 
pending in Japan and Canada.
    The conjugates having capsular polysaccharide from Staphylococcus 
have been exclusively licensed and are not available.

Pertussis Toxin Used as a Carrier Protein With Non-Charged Saccharides 
in Conjugate Vaccines

    Rachel Schneerson, Lily Levi, and John B. Robbins (NICHD), Serial 
No. 07/932,960, Filed 21 Aug 92.
    This invention concerns conjugates of non-charged capsular 
polysaccharides from pathogenic bacteria with pertussis toxin for use 
as vaccines. Bacteria having non-charged capsular polysaccharides 
include Streptococcus pneumoniae types 7 and 14. The invention is 
described in Infection and Immunity 60(9), 3528-3532, 1992. Mice 
injected with Pn14-pertussis toxin conjugates raised serum antibodies 
against both type 14 capsular polysaccharide and pertussis toxin. Also 
claimed are methods of synthesis, immunization methods and vaccines. 
The application has been foreign filed, PCT/US93/07732.

Immunogenic Polysaccharide-Protein Conjugates Containing Poly Alpha (2-
8), Alpha (2-9) Neunac Capsular Polysaccharides

    Rachel Schneerson, John B. Robbins, and Sarvamangala Devi (NICHD), 
Filed 12 Mar 91 (priority date), Serial No. 08/153,263 (CON of 07/
667,170).
    The invention concerns conjugates of E. coli K92 capsular 
polysaccharide and carrier proteins, such as tetanus toxoid. The 
conjugates have been shown to raise antibodies that react with Group B 
and Group C Neisseria meningitis and E. coli K1 capsular 
polysacchrides. The conjugate is a potential vaccine against Group B 
meningitis. Infant rats have been protected from lethal injections of 
E. coli K1 using antisera raised against the conjugates. The invention 
is described in P.N.A.S. 88, 7175-7179 (1991). Applications are pending 
in Canada, Australia, Japan and Europe.

Detoxified LPS-Cholera Toxin Conjugate Vaccine for Prevention of 
Cholera

    Shouson Szu, John B. Robbins, and Rajesh K. Gupta (NICHD), Filed 16 
Jan 92 (priority date), Serial No. 08/171,188 (CON of 07/821,453).
    The invention concerns a conjugate of detoxified lipopolysaccharide 
(LPS) from V. cholera and proteins, potentially useful as a cholera 
vaccine. The LPS is detoxified by treatment with anhydrous hydrazine, 
resulting in a detoxified LPS that is less toxic and more immunogenic 
than cholera LPS's detoxified by other means. The invention has been 
foreign filed, PCT/US93/00253. In a phase I clinical trial, 38 
volunteers were injected with a conjugate of the detoxified LPS and 
tetanus toxoid. The conjugate vaccines of the invention elicit higher 
levels of anti-LPS IgG antibodies than whole cell vaccine. IgG can 
penetrate the intestinal membrane to reach the gut, and, thus, is the 
primary reason for protection. The serum from the volunteers is 
vibriocidal for at least nine months; tests are continuing. In the 
field trials of the whole cell vaccine, protection is correlated with 
the level of serum vibriocidal antibodies.

Synthesis of Typhoid Fever Vaccine From a Plant or Fruit Polysaccharide

    Shouson Szu and Slavomir Bystrisky (NICHD), Filed 17 Oct 94, Serial 
No. 08/323,918.
    The invention is a synthetic Salmonella typhi capsular 
polysaccharide, Vi, made by chemically modifying fruit pectin. The 
synthetic Vi is useful as a component of a subunit vaccine for typhoid 
fever. The synthetic Vi is made by acetylating the C2 and C3 
hydroxyls of the galacturonate subunits of pectin. A vaccine is made by 
conjugating the synthetic Vi to a carrier protein, such as tetanus 
toxoid. The synthetic Vi-tetanus toxoid conjugates were shown to react 
with S. typhi antisera, and when injected into mice raised antibodies 
reactive with natural S. typhi Vi antigen. The conjugates were able to 
elicit a booster effect. Antibodies or antisera raised against the 
conjugates and useful for diagnostic purposes and for passive 
immunization are also part of the invention. The invention is described 
in Infection & Immunity 62, 5545-5549 (1994).

Glucuronoxylomannan-Protein Conjugates of Cryptococcus Neoformans

    Sarvamangala Devi, Rachel Schneerson, John E. Bennett, and John B. 
Robbins (NICHD), Filed 16 Sep 91 (priority date), Serial No. 08/231,444 
(CON of 07/760,143).
    Cryptococcus neoformans is an encapsulated fungus that causes 
systemic infections in humans, particularly in those who are 
immunocompromised. The incidence of infection is high in AIDS patients. 
The invention concerns conjugates of the glucuronoxylomannan (GXM) 
capsular polysaccharide of C. neoformans and carrier proteins such as 
tetanus toxoid or cholrea toxin. These conjugates are potential 
vaccines to be given to people at high risk of HIV infection. Another 
facet of the invention is passive immunization, a therapeutic 
treatment, using antisera or antibodies raised against the conjugates. 
Passive protection has been demonstrated in mice. Human clinical trials 
are ongoing. The basic invention is described in Infection & Immunity 
59, 3700-3707 (1991).

    Dated: January 28, 1995.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 95-2862 Filed 2-6-95; 8:45 am]
BILLING CODE 4140-01-M