[Federal Register: September 21, 1999 (Volume 64, Number 182)]
[Notices]               
[Page 51133]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21se99-65]                         

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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 received by the NIAID 
on or before November 2, 1999 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: mmowatt@nih.gov.

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 is expected to commit 
several scientists off-site to support the activities defined by the 
CRADA Research Plan. These scientists, in collaboration with 
investigators in the LID, 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 will 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 under the CRADA.
    The capability statement must address, with specificity, each of 
the following selection criteria: (1) The technical expertise of the 
Collaborator's Principal Investigator and laboratory group in molecular 
virology, (2) Ability of Collaborator to manufacture experimental 
vaccine lots for parenteral administration under Good Manufacturing 
Practices (GMP) conditions, and (3) Ability to provide adequate and 
sustained funding to support the requisite vaccine safety and efficacy 
studies.

    Dated: September 13, 1999.
Mark L. Rohrbaugh,
Director, Office of Technology Development, NIAID.
[FR Doc. 99-24516 Filed 9-20-99; 8:45 am]
BILLING CODE 4140-01-M