[Federal Register Volume 64, Number 182 (Tuesday, September 21, 1999)]
[Notices]
[Page 51133]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-24516]
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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
