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					 Vanderbilt and Biodefense
        Research
An Opportunity and a Responsibility



          February 26, 2003
Objectives

• To discuss initiatives and opportunities in biodefense
  and emerging infections research

• To discuss Vanderbilt’s participation in a “Regional
  Centers of Excellence in Biodefense” consortium

• To describe Vanderbilt strengths in research with
  potential application to biodefense initiatives

• To identify additional programs with possible
  applicability to biodefense research
The National Institute of Allergy and Infectious Diseases (NIAID)
  supports and carries out biomedical research to understand,
prevent, and treat infectious and immunologic human diseases.
Infectious diseases include those caused by new, emerging and
  re-emerging infectious agents, including those infections that
are intentionally introduced as an act of bioterrorism. The recent
  deliberate exposure of U.S. civilians to spores of the anthrax
   bacterium, Bacillus anthracis, uncovered an unmet need for
   tests to rapidly diagnose, vaccines and immunotherapies to
  prevent, and drugs and biologics to cure diseases caused by
agents of bioterrorism. NIAID and other federal health agencies
 are evaluating and accelerating measures to protect the civilian
   population from the health consequences of such an attack.
Category A
Bacillus anthracis (anthrax)   Arenaviruses
Clostridium botulinum             LCM, Junin virus, Machup
                                  virus, Guanarito virus
Yersinia pestis                   Lassa Fever
Variola major (smallpox) and   Bunyaviruses
  other poxviruses                Hantaviruses
Francisella tularensis            Rift Valley Fever
   (tularemia)                 Flaviruses
                                  Dengue
Viral hemorrhagic fevers       Filoviruses
                                  Ebola
                                  Marburg
Category B
   Brucellosis            (Brucella species)--Lab & Health Professionals

   Epsilon toxin of Clostridium perfringens
   Food safety threats    ( Salmonella species, Escherichia coli O157:H7,
                                                         Shigella)

   Glanders
   Melioidosis
   Psittacosis
   Q fever
   Ricin toxin from Ricinus communis (castor beans)
   Staphylococcal enterotoxin B
   Typhus fever
   Viral encephalitis      (Venezuelan equine encephalitis, eastern equine
                           encephalitis, western equine encephalitis)

   Water safety threats             (Cholera, Cryptosporidium)
Category C

Emerging infectious disease threats such as Nipah virus
  and additional hantaviruses.
NIAID priority areas:

   Tickborne hemorrhagic fever viruses
   Crimean-Congo Hemorrhagic fever virus
   Tickborne encephalitis viruses
   Yellow fever
   Multi-drug resistant TB
   Influenza
   Other Rickettsias
   Rabies
Key Events & Responses
 Select Agent Program Established   Vanderbilt is
                                    registered as a
                                    Select Agent
                                    facility in
                                    December 2000.
Key Events & Responses
 Select Agent Program Established   9/11 emergency
                                    response included
    WTC & Pentagon Attacks          identifying labora-
                                    tories with Select
                                    Agents so that extra
                                    security could be
                                    provided.
                                    VEHS sent out memo
                                    requesting voluntary
                                    disclosure of
                                    possession of Select
                                    Agents.
Key Events & Responses
 Select Agent Program Established   Vanderbilt EH&S
                                    and VUPD
    WTC & Pentagon Attacks          responded to >75
                                    suspicious powders,
       Anthrax Letters              packages, and mail.
                                    [4 responses last
                                    week!]
                                    Conducted several
                                    training sessions
                                    regarding opening
                                    mail, etc.
                                             Anthrax Incidence in HAS District (1988-2002)

                                     100
Incidence per 1 million population




                                                                                                               23
                                      80
                                                                                                         18                18

                                      60
                                                                                                                     12
                                      40
                                                  7                                                 7
                                             6                                           6
                                      20                3                          4          4
                                                                              3
                                                             1     1    1
                                       0
                                           1988       1990       1992       1994       1996       1998        2000        2002
 CLINICAL MANIFESTATIONS

Presentation
    90% present with edema (often massive)
    20-30% febrile (80-90% complain of fevers)
    Other common complaints – tenderness, abdominal
  pain, headache
Location of Lesion
    70% Face and Neck (eyes and mouth)
    15% Arms, 10% Trunk, 5% Legs
Complications of Cutaneous Anthrax Infection
            Persistent     Death
            secondary
             infection      8%
                      3%
   Necrosis
   requiring    11%
  debridement



                                       No
                                   complications

                                       78%
Key Events & Responses
 Select Agent Program Established      Vanderbilt
                                       establishes Lab
    WTC & Pentagon Attacks             Security &
                                       Accountability Task
       Anthrax Letters                 Group - comprised
                                       of faculty, research
          USA PATRIOT Act              administrators,
                                       security, EH&S,
             UConn incident            legal counsel,
                                       Human Resources,
                                       and other
                HHS Inspector
                                       stakeholders.
                General visits begin
Key Events & Responses
 Select Agent Program Established      Vanderbilt
                                       administration
    WTC & Pentagon Attacks             rejected proposal
                                       to work with
       Anthrax Letters                 anthrax based
                                       potential com-
          USA PATRIOT Act              munity concerns.

             UConn incident            IBC had previously
                                       voted approval and
                                       established a
                HHS Inspector
                                       safety plan.
                General visits begin
Key Events & Responses
 Public Health Security. . .Act   Lab Security &
                                  Accountability Task
                                  Group identifies
                                  method by which to
                                  obtain CDC/USDA
                                  notification from
                                  faculty.
Key Events & Responses
 Public Health Security. . .Act   Deans request
                                  electronic (via
    CDC/USDA Notifications due    BioWISE) disclosure
                                  of non-possession or
                                  possession from 700+
                                  faculty members.

                                  Three previously
                                  undisclosed agents
                                  are found; seven
                                  investigators with no
                                  previous disclosure
Key Events & Responses
 Public Health Security. . .Act   IBC overseeing
                                  development of plans
    CDC/USDA Notifications due    required under the
                                  new regulations.
       CDC/APHIS rules
Key Events & Responses
 Public Health Security. . .Act   Acknowledgement
                                  that national security
    CDC/USDA Notifications due    administrators are
                                  very interested and
       CDC/APHIS rules            involved in how
                                  Select Agents are
           Texas Tech incident    handled in our
                                  institutions.
The overall goal of the RCE Program is to develop
       and maintain strong infrastructure and
multifaceted research and development activities
   that will provide the scientific information and
 translational research capacity to make the next
      generation of therapeutics, vaccines and
  diagnostics against the NIAID Category A, B, C
  agents, with particular emphasis on Category A
RBL program will provide support for building
and/or renovating biosafety level (BSL-3)
facility and necessary associated BSL-2
laboratories, animal facilities, and research
support space.
Summary:

        We see biodefense as not only a national
priority but also an exciting research agenda. Thus,
there is a tremendous impetus and opportunity to
conduct research with select agents.
       At the same time in working with select
agents there is a substantial obligation imposed for
assuring safety and security on the institution and
investigators.

				
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