28512 Federal Register / Vol. 72, No. 97 / Monday, May 21, 2007 / Notices 

Vaccine Against Escherichia Coli 

0157 Infection, Composed of Detoxified 

LPS Conjugated to Proteins 

Description of Technology: This 

invention is a conjugate vaccine to 

prevent infection by E. coli 0157:H7, 

particularly in young children under 5 

years of age. E. coli 0157: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 0157: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 0157, 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% of the 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); U.S. Patent Application 

No. 11/015,436 filed 16 Dec 2004 (HHS 

Reference No. E–158–1998/0–US–08). 

Licensing Status: Available for nonexclusive or exclusive licensing. 

Licensing Contact: Peter A. Soukas, 

J.D.; 301/435–4646; 

soukasp@mail.nih.gov. 

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 

John D. Hewes, Ph.D., at 301–435–3121 

or hewesj@mail.nih.gov for more 

information. 

Dated: May 11, 2007. 

Steven M. Ferguson, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. E7–9656 Filed 5–18–07; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN 

National Institutes of Health 

National Cancer Institute; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the National Cancer 

Advisory Board, June 14, 2007, 2 p.m. 

to June 15, 2007, 12 p.m., National 

Institutes of Health, Building 31, 31 

Center Drive, Bethesda, MD 20892, 

which was published in the Federal 

Register on May 2, 2007, 72 FR 24319. 

The notice is being amended to 

change the open session start and end 

times on June 14, 2007 to 1:15 p.m.—

4:20 p.m. and the end time on June 15, 

2007 to 11:45 a.m. The meeting is 

partially Closed to the public. 

Dated: May 14, 2007. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 07–2495 Filed 5–18–07; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meeting. 

The meeting will be closed to the 

public in accordance with the provision 

set forth in sections 552b(c)(4) and 

552b(c)(6), Title 5 U.S.C., as amended. 

The grant applications and the 

discussions could disclose confidential 

trade secrets or commercial property 

such as patentable material, and 

personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Heart, Lung, and 

Blood Initial Review Group; Clinical Trials 

Review Committee. 

Date: June 25, 2007. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Intercontinental Harbor Court, 550 

Light Street, Baltimore, MD 21202. 

Contact Person: Patricia A Haggerty, PhD, 

Section Chief, Clinical Studies and Training 

Scientific Review Group, Review Branch, 

Division of Extramural Research Activities, 

National Heart, Lung, and Blood Institute, 

NIH, 6701 Rockledge Drive, Room 7194, MSC 

7924, Bethesda, MD 20892, 301/435–0288, 

haggertp@nhlbi.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: May 14, 2007. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 07–2488 Filed 5–18–07; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung and Blood 

Institute; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby give of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

Mentored Scientist Award (K99). 

Date: June 28–29, 2007. 

Time: June 28, 2007, 12 p.m. to 10 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Washington Plaza, 10 Thomas Circle 

NW., Washington, DC 20005. 


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