[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