Transcript Why Now…….Why Here June 25, 2007

National Emerging Infectious
Diseases Laboratories
What will be studied?
What are the risks?
Part II
October 1, 2007
Presenters
Mark Klempner, MD
Associate Provost for Research
Director, NEIDL Institute
Jack Murphy, PhD
Professor of Medicine and Microbiology
Chief, Section of Molecular Medicine
Co-Director, NEIDL Institute
The NEIDL will study NIAID Category A, B, & C agents
Category A:
Bacillus anthracis (anthrax)
Clostridium botulinum
Yersinia pestis (plague)
Francisella tularensis (tularemia)
Variola major (smallpox) and other pox viruses (smallpox virus can only be
studied at the CDC BSL-4 facility by international convention –
and will not be studied at the NEIDL)
Viral Hemorrhagic fevers
Arenaviruses
LCM, Junin, Machupo,
Guanarito, Lassa
Bunyaviruses
Hantaviruses
Rift Valley Fever
Flaviviruses
Dengue
Filoviruses
Ebola, Marburg
The NEIDL will study NIAID Category A, B, & C agents
Category B:
Burkolderia pseudomallei (meliodosis
Coxiella burnetii (Q fever)
Brucella sp. (glanders)
Ricin toxin
Epsilon toxin (Clostridium perfringes)
Typhus fever (Rickettsia prowazeki)
Protozoa
Cryptosporidium parvum
Cyclospora cayatenensis
Giardia lamblia
Entamoeba histolytica
Toxoplasma
Microsporidia
Other viruses
Food and Water-borne Pathogens
West Nile virus
Diarrheagenic Escherichia coli
LaCross
Pathogenic Vibrios (e.g., V. cholerae)
California encephalitis
Shigella sp.
Venezuelan equine encephalitis
Salmonella sp.
Western equine encephalitis
Listeria monocytogenes
Japanese encephalitis virus
Campylobacter jejuni
Kyasanur forest virus
Yersinia entercolitica
Viruses
Calciviruses
Hepatitis A
The NEIDL will study NIAID Category A, B, & C agents
Category C:
Emerging infectious diseases
Nipah virus
Hantaviruses (other)
Tickborne hemorrhagic viruses
Crimean Congo hemorrhagic fever virus
Tickborne encephalitic viruses
Yellow fever
Multi-drug resistant Mycobacterium tuberculosis
Influenza
Other Rickettsias
Rabies
The following agents must be studied under
BSL-4 containment.
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1) Central European tick-borne encephalitis
2) Congo-Crimean hemorrhagic fever
3) Ebola
4) Guanarito
5) Hendra/Nipah
6) Junin
7) Kyasanur Forest disease
8) Lassa
9) Machupo
10) Marburg
11) Omsk hemorrhagic fever
12) Russian Spring-Summer encephalitis
13) Sabia
http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html
BSL-4 agents that will not be studied at the NEIDL
Smallpox - by international convention smallpox can only
be studied in the U.S. at the CDC BSL-4 laboratory
in Atlanta, Georgia
Monkey B virus - there is only one laboratory that has been
contracted by the NIH to study Monkey
B virus – Georgia State University,
Atlanta, Georgia
Who has the BSL-4 expertise & what will they study
when the NEIDL opens?
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Dr. Tom Geisbert – Ebola, Marburg, Lassa, Nipah (likely)
~ 20 years experience working at BSL-4; work has lead
to prototype vaccine for Ebola
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Joan Geisbert – Ebola, Marburg, Lassa, Nipah (likely)
~ 25 years experience working at BSL-4; work has
involved the training of most all BSL-4 investigators in
the U.S. and has assisted in development of prototype
vaccine for Ebola
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Dr. Elke Muhlenberger – Ebola, Marburg, Nipah (likely)
~ 15 years experience working at BSL-4; work has
focused on the molecular biology of Ebola and
Marburg virus
What are the risks to the community from the
NEIDL?
Material
Form
Community
Risk
1
hemorrhagic fever
viruses
liquid
negligible – transmission
by intimate contact with
infected bodily fluids
2
anthrax
liquid
negligible – liquid
contains spore dispersion
3
tularemia
liquid
negligible - no person to
person spread
4
MDR tuberculosis
liquid
Negligible from the
NEIDL – agent is already
in the community
5
Protein Toxins (e.g.,
botulinum, ricin)
liquid
negligible – “chemical”
There are many safeguards to minimize risks
to protect the community
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Building system and design
Experienced BSL-4 investigators have & are being
recruited
Rigorous safety and security Standard Operating
Procedures (SOPs) that must be followed by
researchers
Agents are stored as frozen liquid in inventoried
small volumes
Single vial thawed for individual experiments
There are many safeguards to minimize risks
to protect the community
■ Limited access to the NEIDL and security checks of
persons and property
■ Collaborative Training Programs with city agencies
■ Integration of staff and knowledge with BMC clinicians
■ Institutional Biosafety Committee oversight of
experimental protocols
all
■ Boston Public Health Commission regulations & oversight
■ Massachusetts Department of Public Health
■ NIH and CDC guidelines, regulations & oversight
How do we decide what will be studied in the NEIDL?
■ Expertise of investigators who have been and will be
recruited to the NEIDL institute
■ Programmatic initiatives instituted by the NEIDL (e.g.,
MDR- tuberculosis)
■ Ongoing research programs at BUMC which require high
containment laboratories (e.g., tularemia)
■ The funding of research grant submissions to support
individual research programs in the NEIDL
■ Regulatory approval of individual research programs and
protocols by both institutional committees (e.g., IBC)
and Boston Public Health Commission
How Will the Community Know
What’s Being Studied?
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Institutional Biosafety Committee (public
representation)
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NEIDL Institute Executive Committee (public
representative)
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NEIDL External Scientific Advisory Committee
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Boston Public Health Commission
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Community Liaison Committee
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Mass. Department of Public Safety
The NEIDL is Accountable to Independent Public
Health and Safety Officials
LOCAL
Institutional Biosafety Committee
Boston Public Health Commission
Boston Fire Department
Boston Inspectional Services
Boston Water and Sewer Commission
STATE
Massachusetts Department of Public Health
Massachusetts Department of Environmental Protection
Massachusetts Water Resources Authority
FEDERAL
Centers for Disease Control
U.S. Department of Transportation
U.S. Environmental Protection Agency
Occupational Health & Safety Administration
National Institutes of Health
U.S. Department of Agriculture
Nuclear Regulatory Commission
Q&A