[Federal Register Volume 63, Number 51 (Tuesday, March 17, 1998)]
[Notices]
[Pages 13057-13058]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-6788]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Deafness and Other Communication Disorders
(NIDCD); Opportunity for a Cooperative Research and Development
Agreement (CRADA) for the Development of a Vaccine Against Moraxella
Catarrhalis Mediated Otitis Media
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: Moraxella catarrhalis is the third most common pathogen for
otitis media, the most common cause of illness requiring medical
treatment in children. The NIDCD is investigating candidate vaccines
based on detoxified lipooligosaccharide-protein conjugates prepared
from surface antigens of Moraxella catarrhalis.
The NIDCD, NIH, is seeking capability statements from parties
interested in entering into a CRADA for the development of a candidate
vaccine with the goal of conducting a Phase I clinical trial to
determine the safety for most promising candidates. This project is
with the Section on Experimental Immunology, Laboratory of Immunology,
National Institute on Deafness and Other Communication Disorders, NIH.
The goals are to use the respective strengths of both parties to
achieve one or more of the following: (1) Establish an animal model to
test experimental vaccines to provide protection against Moraxella
catarrhalis mediated otitis media; (2) screen experimental vaccines for
their relative efficacy; (3) determine the efficacy of the most
promising vaccines; (4) prepare a sufficient quantity of vaccine to
gain IND approval from the FDA and to conduct a Phase I clinical trial.
Additional investigations may be undertaken when the efficacy of the
candidate vaccines has been determined in an animal model and safety in
humans has been assured.
It is anticipated that the commercial collaborator(s) will
participate in
[[Page 13058]]
ongoing studies involving the determination of the efficacy and
identification of most promising vaccines, preparing the vaccine for a
clinical trial, and assisting in the conduct of such a trial. The
collaborator may also be expected to contribute financial support under
this CRADA for personnel, supplies, travel and equipment to support
these projects.
CRADA capability statements should be submitted to Ms. Lili
Portilla, Technology Transfer Manager, National Heart, Lung, and Blood
Institute (NHLBI), Technology Transfer Service Center, 31 Center Drive
MSC 2490, Building 31/Room 1B30, Bethesda, MD 20892-2490, Phone: (301)
402-5579, Fax: (301) 594-3080, E-mail address
. Capability statements must be received by
the NHLBI on or before May 1, 1998.
The NIDCD has applied for patents claiming the core of the
technology. Non-exclusive and/or exclusive licenses for these patents
covering core aspects of this project are available to interested
parties.
Licensing inquiries regarding this technology should be referred to
Ms. Elaine Gese, M.B.A., Licensing Specialist, NIH Office of Technology
Transfer, Suite 325, 6011 Executive Blvd., Suite 325, Rockville, MD
20852, Phone: (301) 496-7735, Ext. 282, Fax: (301) 402-0220, E-mail
addressgesee@od6100ml.od.nih.gov>
Dated: March 5, 1998.
Sheila E. Merritt,
Executive Officer, NHLBI.
[FR Doc. 98-6788 Filed 3-16-98; 8:45 am]
BILLING CODE 4140-01-M
