[Federal Register Volume 68, Number 91 (Monday, May 12, 2003)]
[Notices]
[Pages 25383-25384]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-11720]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Allergy and Infectious Diseases: Licensing 
Opportunity and Cooperative Research and Development Agreement 
(``CRADA'') Opportunity; Live Attenuated Vaccine To Prevent Disease 
Caused by West Nile Virus

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

ACTION: Notice.

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SUMMARY: The National Institute of Allergy and Infectious Diseases 
(NIAID) of the NIH is seeking licensees and/or CRADA partners to 
further develop, evaluate, and commercialize modified West Nile virus 
(WNV) chimeras as a live attenuated vaccine against infections of WNV 
in humans. NIAID is also seeking licensees to commercialize modified 
WNV chimeras as live attenuated veterinary vaccines against infections 
of WNV in animals.

DATES: Respondents interested in licensing the invention will be 
required to submit an ``Application for License to Public Health 
Service Inventions'' on or before August 11, 2003, for priority 
consideration.
    Interested CRADA collaborators must submit a confidential proposal 
summary to the NIAID (attention Richard K. Williams, Ph.D. at the 
address mentioned below) on or before August 11, 2003, for 
consideration. Guidelines for preparing full CRADA proposals will be 
communicated shortly thereafter to all respondents with whom initial 
confidential discussions will have established sufficient mutual 
interest. CRADA and PHS License Applications submitted thereafter may 
be considered if a suitable CRADA collaborator or Licensee(s) has not 
been selected.

ADDRESSES: Questions about licensing opportunities should be addressed 
to Peter Soukas, J.D., Technology Licensing Specialist, Office of 
Technology Transfer, National Institutes of Health, 6011 Executive 
Boulevard, Suite 325, Rockville, Maryland 20852-

[[Page 25384]]

3804, Telephone: (301) 435-4646; Facsimile: (301) 402-0220; E-mail: 
[email protected]. Information about Patent Applications and pertinent 
information not yet publicly described can be obtained under the terms 
of a Confidential Disclosure Agreement. Respondents interested in 
licensing the invention will be required to submit an ``Application for 
License to Public Health Service Inventions.''
    Depending upon the mutual interests of the Licensee(s) and the 
NIAID, a CRADA to collaborate to develop WNV vaccines in humans may 
also be negotiated. Proposals and questions about this CRADA 
opportunity should be addressed to Richard K. Williams, Ph.D., 
Technology Development Associate, Office of Technology Development, 
NIAID, 6610 Rockledge Drive, Room 4071, Bethesda, MD 20892-6606, 
Telephone: (301) 402-0960; E-mail: [email protected]. Respondents 
interested in submitting a CRADA Proposal should be aware that it may 
be necessary to secure a license to the above-mentioned patent rights 
in order to commercialize products arising from a CRADA.

SUPPLEMENTARY INFORMATION: WNV has recently emerged in the U.S. and is 
considered a significant emerging disease that has embedded itself over 
a considerable region of the U.S. WNV infections have been recorded in 
humans as well as in different animals. To date, WNV has killed 294 
people in the U.S. and caused severe disease in more than 4222 others. 
This project is part of NIAID's comprehensive emerging infectious 
disease program, which supports research on bacterial, viral, and other 
types of disease-causing microbes.
    The methods and compositions of this invention provide a means for 
prevention of WNV infection by immunization with attenuated, 
immunogenic viral vaccines against WNV. The invention involves a 
chimeric virus form consisting of parts of WNV and Dengue virus. 
Construction of the hybrids and their properties are described in 
detail in PNAS, Pletnev AG et al., 2002; 99(5):3036-3041.
    The WNV chimeric vaccine does not target the central nervous 
system, which would be the case in an infection with wild type WNV. The 
vaccine stimulates strong anti-WNV immune responses, even following a 
single dose of the vaccine. When injected into mice, the vaccine 
protected all of the immunized animals from subsequent exposure to the 
New York WNV strain. The vaccine was also effective in primates. 
Researchers intend to begin human trials in late 2003.
    The WNV vaccine may be used to protect the human population, 
particularly the elderly people, and domestic animals from WNV 
infection in the affected regions of the U.S. as well as worldwide.
    The invention claimed in DHHS Reference No. E-357-01/0, 
``Construction of West Nile Virus and Dengue Virus Chimeras for Use in 
a Live Virus Vaccine to Prevent Disease Caused by West Nile Virus'' (AG 
Pletnev et al.), PCT/US03/00594 filed Jan 09, 2003, is available for 
exclusive or non-exclusive licensing for developing a vaccine against 
WNV for humans or veterinary use in accordance with 35 U.S.C. 207 and 
37 CFR part 404. NIAID is also interested in further development of the 
technology under one or more CRADAs in the human applications described 
below.
    Under the CRADA the production of WNV vaccines for humans will be 
optimized and the vaccine evaluated in a series of clinical studies in 
humans as well as initial safety testing in humans. Positive outcomes 
of these studies will indicate continued clinical development aimed at 
supporting regulatory approval of a product to be labeled for use in 
humans. The Public Health Service (PHS) has filed patent applications 
both in the U.S. and internationally related to this technology. Notice 
of the availability of the patent application for licensing was first 
published in the Federal Register on May 2, 2002 (67 FR 22093).
    NIAID's principal investigator has extensive experience with live 
attenuated vaccines, their production and testing, and clinical trials. 
The Collaborator in this endeavor is expected to assist NIAID in 
evaluating its current system for producing the WNV chimeras claimed in 
the patent applications and to develop and optimize an alternative 
production method, if necessary, to manufacture sufficient quantities 
of the vaccine for clinical testing in humans and initial safety 
studies in humans. The Collaborator must have experience in the 
manufacture of live attenuated vaccines according to applicable FDA 
guidelines and Points to Consider documents to include Good 
Manufacturing Procedures (GMP). In addition, it is expected that the 
Collaborator would provide funds to supplement the LID's research 
budget for the project and to support the initial human testing.
    The capability statement should include detailed descriptions of: 
(1) Collaborator's expertise in the production of live attenuated 
vaccines, (2) Collaborator's ability to manufacture sufficient 
quantities of the vaccine according to FDA guidelines and Points to 
Consider documents, (3) the technical expertise of the Collaborator's 
principal investigator and laboratory group in preclinical safety 
testing (e.g., expertise in in vitro and in vivo toxicity and 
pharmacology studies) and initial human safety studies, and (4) 
Collaborator's ability to provide adequate funding to support initial 
human safety studies required for marketing approval.

    Dated: April 25, 2003.
Michael Mowatt,
Director, Office of Technology Development, NIAID.
    Dated: May 1, 2003.
Steven M. Ferguson,
Acting Director, Division of Technology Development and Transfer, 
Office of Technology Transfer.
[FR Doc. 03-11720 Filed 5-9-03; 8:45 am]
BILLING CODE 4140-01-P