[Federal Register Volume 63, Number 38 (Thursday, February 26, 1998)]
[Notices]
[Page 9846]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-4880]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and Infectious Diseases;
Opportunity for a Cooperative Research and Development Agreement
(CRADA) To Develop Live Attenuated Dengue Viruses for Use as Vaccines
in Humans
AGENCY: National Institutes of Health, Public Health Service, DHHS.
ACTION: Notice.
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SUMMARY: The National Institute of Allergy and Infectious Diseases
(NIAID) of the National Institutes of Health (NIH) is seeking
capability statements from parties interested in entering into a
Cooperative Research and Development Agreement (CRADA) on a project to
develop live attenuated dengue viruses for use as vaccines to prevent
dengue hemorrhagic fever and dengue shock syndrome in humans. This
project is part of ongoing vaccine development activities in the
Laboratory of Infectious Diseases (LID), Division of Intramural
Research, NIAID.
DATES: Only written CRADA capability statements which are received by
the NIAID on or before March 30, 1998 will be considered.
ADDRESSES: Capability statements should be submitted to Dr. Michael R.
Mowatt, Office of Technology Development, National Institute of Allergy
and Infectious Diseases, National Institutes of Health, 31 Center Drive
MSC 2137, Building 31, Room 3B62, Bethesda, MD 20892-2137; Tel: 301/
496-2644, Fax: 301/402-7123; Electronic mail: [email protected].
SUPPLEMENTARY INFORMATION: The CRADA will employ attenuated dengue
virus strains (types 1 through 4) developed in LID using recombinant
DNA methodologies to (1) Identify and characterize the mutations
responsible for attenuation, (2) engineer viral strains suitably
attenuated for use as human vaccines, and (3) evaluate the attenuated
viruses as live vaccines in animals and humans. The Public Health
Service (PHS) has filed patent applications both in the U.S. and
internationally related to these technologies.
The LID has extensive experience in evaluating the safety,
antigenicity, immunogenicity and efficacy of various human viral
pathogens and vaccines thereof both in experimental animals and human
volunteers. The Collaborator in this endeavor would be required to
provide and maintain at least four scientists off-site to support the
CRADA Research Plan. These scientists would coordinate the production
and release testing of the candidate vaccines, generate monoclonal
antibodies needed for manufacture of clinical lots and for their
clinical evaluation, and use molecular virologic techniques to generate
attenuating mutations suitable for use in live vaccine candidates. In
addition, it is expected that the Collaborator would provide funds to
supplement LID's research budget for the project and would make a major
funding commitment to support the safety, immunogenicity and efficacy
studies for candidate vaccines developed and licensed under the CRADA.
The capability statement should include detailed descriptions of:
(1) The technical expertise of the Collaborator's Principal
Investigator and laboratory group in molecular virology, (2) Ability of
Collaborator to manufacture at least four experimental vaccine lots per
year, and (3) Ability to provide adequate and sustained funding to
support the requisite vaccine safety and efficacy studies.
Dated: February 19, 1998.
Mark L. Rohrbaugh,
Director, Office of Technology Development, NIAID.
[FR Doc. 98-4880 Filed 2-25-98; 8:45 am]
BILLING CODE 4140-01-M