Medical Safety
Resume:
CURRICULUM VITAE
Anna Palmer Durbin
BUSINESS ADDRESS
Hampton House, Room 251
Baltimore, MD 21205
Tel. 410-***-****
Fax. 410-***-****
Email: abqk9d@r.postjobfree.com
EDUCATION AND TRAINING
University of Michigan, Ann Arbor, MI; Pharmacy
B.S./-b(6)-
School of Medicine, Wayne State University, Detroit, MI; Medicine
M.D./1987
Postdoctoral Training
Resident, Department of Internal Medicine, Detroit Medical Center,
1987-1990
Wayne State University, Detroit, Michigan.
Chief Medical Resident, Detroit Receiving Hospital, Detroit
1990-1991
Medical Center, Wayne State University, Detroit, Michigan.
Fellow, Division of Infectious Diseases, Detroit Medical Center, Wayne
1991-1994
State University, Detroit, Michigan.
Medical Licensure
1987 present Michigan Medical License # -b(6
1994 present State of Maryland Medical License #-b(6
2006 present District of Columbia Medical License #-b(6
Medical Board Certification
1990 Diplomat in Specialty of Internal Medicine, American Board of Internal
Medicine.
1994 Diplomat in Subspecialty of Infectious Diseases, American Board of Internal
Medicine
2000 Recertification, Specialty of Internal Medicine
2004 Recertification, Subspecialty of Infectious Diseases
PROFESSIONAL EXPERIENCE
Associate Professor, Department of International Health, Johns
2007 - present
Hopkins Bloomberg School of Public Health (BSPH), Center for
Immunization Research (CIR). Principal responsibilities:
Principal Investigator for numerous Phase I clinical trials of
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flavivirus and malaria vaccines, performing clinical and basic
research into the immuno-pathogenesis of dengue, advising
students in the MPH, MHS, and PhD programs at the School of
Public Health, teaching in the School of Public Health, serving on
school and university-wide committees.
Assistant Professor, Department of International Health, Johns
1999 - 2007
Hopkins Bloomberg School of Public Health (BSPH), Center for
Immunization Research (CIR). Principal responsibilities: Principal
Investigator for numerous Phase I clinical trials of flavivirus and
malaria vaccines, performing clinical and basic research into the
immuno-pathogenesis of dengue, advising students in the MPH
and MHS, programs at the School of Public Health, teaching in the
School of Public Health, serving on school-wide and university-
wide committees.
Joint appointment, Department of Medicine, Division of Infectious
1999 present
Diseases, Johns Hopkins School of Medicine. Duties: Attending
physician in the Moore Clinic, the HIV outpatient clinic of the
Johns Hopkins Medical Institutions. Supervision and teaching of
Infectious Disease fellows and medical students during clinic
sessions.
Clinical Fellow, Respiratory Virus Section, Laboratory of
1994 - 1999
Infectious Diseases, National Institute of Allergy and Infectious
Diseases, National Institutes of Health. Duties: Developed live
attenuated respiratory virus vaccine candidates using recombinant
DNA technology.
PROFESSIONAL ACTIVITIES
Society Membership and Leadership
American Society of Virology
Infectious Diseases Society of America
American Society of Tropical Medicine and Hygiene
American College of Physicians
2005: Chair, Dengue vaccine session, American Society of Tropical Medicine and
Hygiene meeting
2006: Chair, Flavivirus V- Dengue III. American Society of Tropical Medicine and
Hygiene meeting
Participation on Advisory Panels
Reviewer for the Wellcome Trust Research Career
2010
Development Fellowship
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2008 present Advisor, WHO Task Force on Clinical trials of Dengue
Vaccines
Chair, Safety monitoring committee, --b(4 sponsored
2008 present
Phase 1/2a trial of the --b(4 vaccine administered
subcutaneously or intradermally to --b(4 adult
volunteers
2008 present Brighton Collaboration Yellow Fever Group
2008 present Brighton Collaboration V3SWG Cross-Cutting Issues
Subgroup
2007- present Chair, Data Safety and Monitoring Board, WRAIR,
Randomized, Controlled Phase 2 Clinical Trial to Evaluate
the Safety, Immunogenicity and Efficacy of the AMA-1
Malaria Vaccine FMP2.1/ASO2A vs Rabies Vaccine in 1-6
Year Old Children in Bandiagara, Mali.
CDC Yellow Fever Vaccine Working Group
2002 2008
Chair, Data Safety and Monitoring Board, WRAIR, Phase I
2006 - 2007
Evaluation AMA1 malaria vaccine (FMP2.1) in 1-6 year
old children Bandiagara, Mali.
Temporary Advisor, WHO Task Force on Clinical Trials of
2002 2006
Dengue Vaccines.
Consultations
2009 present DSMB Chair, --b(4)-- sponsored Phase II clinical trial of
-b(4)- administered with b(4
EDITORIAL ACTIVITIES
Peer Reviewer Activities
Clinical Infectious Diseases
Experimental Biology and Medicine
Infection and Immunity
Journal of Infectious Diseases
Journal of Medical Virology
Journal of the American Society of Tropical Medicine and Hygiene
PLoS Neglected Tropical Diseases
PloS One
Trials
Vaccine
Virology
Virus Research
Hemorrhagic fever virus chapters for the 27th edition of the Red Book.
Ad Hoc Review of Proposals
2009 Member of the NIH Special Emphasis Panel Review of PO1-AI86132-01
CD8 Immune Responses Against Viral Pathogens
2009 NIH NICHD Loan Repayment Project (LRP)
2008 NIH NICHD Loan Repayment Project (LRP)
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2007 Reviewer for the NIH RFA on the Global Network for Women s and
Children s Health
2007 Member of the NIH Special Emphasis Panel ZA/a-MPM-M-M1 for the
PO1 application Prevention and Management of Dengue Virus
2007 Member of the National Institutes of Health Center for scientific Review
Infectious Diseases and Microbiology Integrated Review Group Clinical
Research and Field Studies of Infectious Diseases Study Section
2006 Reviewer of Dengue Vaccine research grant proposals sent to the US
Army Medical Research and Material Command for funding
2004 - 2006 Center for AIDS Research Grants
2003 Member, review panel for USAID Research Support Program, National
Academy of Sciences Animal Science & Agricultural/Livestock
Economics
2001 Review panel for NIH contract Evaluation of control measures for
diseases other than AIDS, RFP NIH-NIAID-DMID-02-01.
HONORS AND AWARDS
Honors
1980 Rho Chi Honor Society, College of Pharmacy
1983 Julia Emmanuel Award for Academic Excellence
Awards
2000 Faculty Development Award
2005 National Institutes of Health Merit Award for outstanding basic and
translational research in developing vaccines for the prevention of respiratory
virus and flavivirus diseases
U. S. PATENTS ALLOWED
Title: Recombinant parainfluenza virus vaccines attenuated by deletion or
ablation of a non-essential gene
Inventors: Durbin A.P., Collins P.L., and Murphy B.R.
Patent No: 6410023
Date: June 25, 2002
Title: Use of recombinant live-attenuated parainfluenza viruses (PIVs) as a
vector to protect against infection and disease caused by PIV and other
human pathogens
Inventors: Murphy B.R., Collins P.L., Schmidt, A.C., Durbin A.P., Skiadopoulos
M.H., and Tao Tao
Patent No: 7192593
Date: March 20, 2007
Title: Attenuated human-bovine chimeric parainfluenza virus (PIV) vaccines
Inventors: Schmidt, A.C., Skiadopoulos M.H., Collins P.L., Murphy B.R., Bailly,
J.E., Durbin A.P.
Patent No: 7201907
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Date: April 10, 2007
Title: Production of attenuated parainfluenza virus vaccines from cloned
nucleotide sequences
Inventors: Murphy B.R., Collins P.L., Durbin A.P., Skiadopoulos M.H., and Tao
Tao
Patent No: 7208161
Date: April 10, 2007
Title: Use of recombinant live-attenuated parainfluenza virus (PIV) as a vector
to protect against disease caused by PIV and respiratory syncytial virus
(RSV)
Inventors: Murphy B.R., Collins P.L., Durbin A.P., Skiadopoulos M.H., and Tao
Tao
Patent No: 7314631
Date: January 1, 2008
U. S. PATENTS SUBMITTED
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PUBLICATIONS IN PEER-REVIEWED JOURNALS
Journal Articles
Durbin AP, Siew JW, Murphy BR, Collins PL. Minimum protein requirements for
transcription and RNA replication of a minigenome of human parainfluenza virus type 3
and evaluation of the rule of six. Virology 1997;234: 74-83.
Durbin AP, Hall SL, Siew JW, Whitehead SS, Collins PL, Murphy BR. Recovery of
infectious human parainfluenza virus type 3 from cDNA. Virology 1997;235:323-332.
Durbin AP, Wyatt LS, Siew J, Moss B, Murphy BR. The immunogenicity and efficacy
of intranasally or parenterally administered replication-deficient vaccinia-parainfluenza
virus type 3 recombinants in rhesus monkeys. Vaccine 1998 16:1324-30.
Skiadopoulos MH, Durbin AP. Tatem JM, Wu SL, Paschalis M, Tao T, Collins PL,
Murphy BR. Three amino acid substitutions in the L protein of the human parainfluenza
virus type 3 cp45 live attenuated vaccine candidate contribute to its temperature-sensitive
and attenuation phenotypes. J Viro, 1998 Mar;72(3):1762-1768.
Tao T, Durbin AP, Whitehead SS, Davoodi F, Collins PL, Murphy BR. Recovery of a
recombinant chimeric human parainfluenza virus (PIV) type 3 in which the
hemagglutinin neuraminidase and fusion glycoproteins have been replaced by those of
PIV type 1. J Virol 1998;72: 2955-2961.
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Durbin AP, Cho CJ, Elkins WR, Wyatt LS, Moss B, Murphy BR. Comparison of the
immunogenicity and efficacy of a replication-defective vaccinia virus expressing
antigens of human parainfluenza virus type 3 (HPIV3) with that of a live attenuated
HPIV3 vaccine candidate in rhesus monkeys passively immunized with PIV3 antibodies.
J Infect Dis 1999;179(6):1345-51.
Durbin AP, McAuliffe JM, Collins PL, Murphy BR. Mutations in the C, D and V open
reading frames of human parainfluenza virus type 3 attenuate replication in rodents and
primates. Virology 1999;261:319-330.
TaoT, Skiadopoulos MH, Durbin AP, Davoodi F, Collins PL, Murphy BR. A live
attenuated chimeric recombinant parainfluenza virus (PIV) encoding the internal proteins
of PIV type 3 and the surface glycoproteins of PIV type 1 induces complete resistance to
PIV1 challenge and partial resistance to PIV3 challenge. Vaccine 1999;17:1100-8.
Skiadopoulos MH, Surman S, Tatem JM, Paschalis M, Wu S-L, Udem SA, Durbin AP,
Collins PL, Murphy BR. Identification of mutations contributing to the temperature-
sensitive, cold-adapted, and attenuation phenotypes of the live attenuated cold-passage 45
(cp45) human parainfluenza virus 3 candidate vaccine. J Virol 1999;73(2):1374-1381.
Durbin AP, Elkins WR, and Murphy BR. African green monkeys provide a useful
nonhuman primate model for the study of human parainfluenza virus types -1, -2,and -3
infection. Vaccine 2000;18:2462-2469.
Durbin AP, Skiadopoulos MH, McAuliffe JM, Riggs JM, Surman SR, Collins PL, and
Murphy BR. Human parainfluenza virus type 3 (PIV3) expressing the hemagglutinin
protein of measles virus provides a potential method for immunization against measles
virus and PIV3 in early infancy. J Virol, 2000 Aug;74(15):6821-6831.
Tao T, Davoodi F, Cho CJ, Skiadopoulos, MH, Durbin AP, Collins PL, Murphy BR. A
live attenuated recombinant chimeric parainfluenza virus (PIV) candidate vaccine
containing the hemagglutinin-neuraminidase and fusion glycoproteins of PIV1 and the
remaining proteins from PIV3 induces resistance to PIV1 even in animals immune to
PIV3. Vaccine 2000;18:1359-1366.
Bailly JE, McAuliffe JM, Durbin AP, Elkins WR, Collins PL, Murphy BR. A
recombinant human parainfluenza virus type 3 (PIV3) in which the nucleocapsid N
protein has been replaced by that of bovine PIV3 is attenuated in primates. J Virol
2000;74(7):3188-3195.
Skiadopoulos MH, Surman SR, Durbin AP. Collins PL.Murphy BR. Long nucleotide
insertions between the HN and L protein coding regions of human parainfluenza virus
type 3 yield viruses with temperature-sensitive and attenuation phenotypes. Virology
2000;272:225-234.
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Durbin AP, Karron RA, Thumar B, Sun W, Vaughn DW, Reynolds MJ, Perreault JR,
Men R, Lai CJ, Elkins WR, Chanock RM, Murphy BR, Whitehead SS. A live attenuated
dengue virus type 4 vaccine candidate with a 30 nucleotide deletion in the 3 untranslated
region is highly attenuated and immunogenic in humans. Am J Trop Med Hyg,
2001;65:405-413.
Troyer JM, Hanley KA, Whitehead SS, Strickman D, Karron RA, Durbin AP, Murphy
BR. A live attenuated dengue-4 virus vaccine candidate with a 30 base pair deletion in
its 3 untranslated region has restricted capacity for dissemination in mosquitoes and is
not transmitted from vaccinees to mosquitoes. Am J Trop Med Hyg, 2001;65:414-419.
Durbin, AP and Karron, RA. Progress in the Development of Respiratory Syncytial
Virus and Parainfluenza Virus Vaccines. Clin Inf Dis, 2003:37;1668-1677.
Barwick, R for the Yellow Fever Working Group. History of thymoma and yellow fever
vaccination. Lancet 2004:364;936.
Durbin, AP, Whitehead SS, McArthur J, Perreault JR, Blaney JE Jr., Thumar B, Murphy
BR, and Karron RA. rDEN4 30, a live attenuated dengue virus type 4 vaccine candidate,
is safe, immunogenic, and highly infectious in healthy adult volunteers. J Infect Dis.
2005:191;710-718.
Malkin EM, Durbin AP*, Diemert DJ, Sattabongkot J,Wu Y, Miura K, Long CA,
Lambert L, Miles AP, Wang J, Stowers AW, Miller LH, Saul A. Phase 1 Vaccine Trial of
Pvs25H: A Transmission Blocking Vaccine for Plasmodium vivax Malaria. Vaccine
2005:23(24):3131-3138.
Khromava AY, Eidex RB, Weld LH, Kohl KS, Bradshaw RD, Chen RT, Cetron MD, and
the Yellow Fever Vaccine Safety Working Group. Yellow fever vaccine: An updated
assessment of advanced age as a risk factor for serious adverse events. Vaccine.
2005:23(25);3256-3263.
Malkin, EM, Diemert DJ, McArthur JH, Perreault JR, Miles AP, Giersing BK, Mullen
GE, Orbutt A, Awkal M, Zhou H, Want J, Stowers AW, Long CA, Mahanty S, Miller
LH, Saul A, Durbin AP. Phase 1 clinical trial of apical membrane antigen 1 (AMA1):
An asexual blood stage vaccine for Plasmodium falciparum malaria. Infect. Immun.
2005:73(6);3677-3685.
Taylor DN, McKenzie R, Durbin AP, et al. Rifaximin, a nonabsorbed oral antibiotic,
prevents shigellosis after experimental challenge. Clin Infect Dis 2006;42:1283-8.
Blaney JE, Jr., Durbin AP, Murphy BR and Whitehead SS. Development of a live
attenuated dengue virus vaccine using reverse genetics. Viral Immunol 2006;19:10-32.
Durbin, AP, McArthur JH, Marron JA, Blaney JE Jr., Thumar Wanionek K, Murphy
BR, and Whitehead SS. 2006. The live attenuated dengue serotype 1 vaccine rDEN1 30
is safe and highly immunogenic in healthy adult volunteers. Human Vaccin 2(4):167-173.
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Durbin, AP, McArthur JH, Marron JA, Blaney JE Jr, Thumar B, Wanionek K, Murphy
BR, and Whitehead SS. 2006. rDEN2/4Delta30(ME), A Live Attenuated Chimeric
Dengue Serotype 2 Vaccine Is Safe and Highly Immunogenic in Healthy Dengue-Naive
Adults. Hum Vaccin 2(6):255-260.
Whitehead SS, Blaney JE, Durbin AP and Murphy BR. Prospects for a dengue virus
vaccine. Nat Rev Microbiol 2007;5:518-28.
Wright PF, Ankrah S, Henderson SE, Durbin AP, Speicher J, Whitehead SS, et al.
Evaluation of the Langat/dengue 4 chimeric virus as a live attenuated tick-borne
encephalitis vaccine for safety and immunogenicity in healthy adult volunteers. Vaccine
2008 Feb 13;26(7):882-90.
Taylor, D. N., R. McKenzie, A. Durbin, C. Carpenter, R. Haake, and A. L. Bourgeois.
2008. Systemic pharmacokinetics of rifaximin in volunteers with shigellosis. Antimicrob
Agents Chemother 52:1179-1181.
Durbin, A. P., M. J. Vargas, K. Wanionek, S. N. Hammond, A. Gordon, C. Rocha, A.
Balmaseda, and E. Harris. 2008. Phenotyping of peripheral blood mononuclear cells
during acute dengue illness demonstrates infection and increased activation of monocytes
in severe cases compared to classic dengue fever. Virology 2008;376:429-35.
Vasilakis N, Durbin AP, Travassos da Rosa A, Munoz-Jordan JL, Tesh RB, and Weaver
S. Antigenic Relationships Between Sylvatic and Endemic Dengue Viruses. Am J Trop
Med Hyg 2008;79:128-32.
Wu Y, Ellis RD, Shaffer D, Fontes, E, Malkin EM, Mahanty S, Fay MP, Narum D,
Rausch K, Miles AP, Aebig J, Orcutt A, Muratova O, Song G, Lambert L, Zhu D, Miura
K, Long C, Saul A, Miller LH, and Durbin AP. Phase 1 trial of malaria transmission
blocking vaccine candidates Pfs25 and Pvs25 formulated with montanide ISA 51. PLoS
ONE 2008;3:e2636.
Nelson S, Jost CA, Xu Q, Ess J, Martin JE, Oliphant T, Whitehead SS, Durbin AP,
Graham BS, Diamond MS, Pierson TC. Maturation of West Nile virus modulates
sensitivity to antibody-mediated neutralization. PLoS Pathog 2008;4:e1000060
Durbin AP, McArthur JH, Marron JA, Blaney JE Jr, Thumar B, Wanionek K, Murphy
BR, and Whitehead SS. Phase I Study of the Safety and Immunogenicity of rDEN4 30
200,201 a Live Attenuated Virus Vaccine Candidate for the Prevention of Dengue
Serotype 4. Am J Trop Med Hyg 2008;79(5):678.
Crompton PD, Mircetic M, Weiss G, Baughman A, Huang CY, Topham DJ, Treanor JJ,
Sanz I, Lee FE, Durbin AP, Miura K, Narum DL, Ellis RD, Malkin E, Mullen GE,
Miller LH, Martin LB, and Pierce SK. The TLR9 ligand CpG promotes the acquisition of
Plasmodium falciparum-specific memory B cells in malaria-naive individuals. J Immunol
2009;182:3318-26.
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Ellis RD, Mullen GE, Pierce M, Martin LB, Miura K, Fay MP, Long CA, Shaffer D, Saul
A, Miller LH, and Durbin AP. A Phase 1 study of the blood-stage malaria vaccine
candidate AMA1-C1/Alhydrogel((R)) with CPG 7909, using two different formulations
and dosing intervals. Vaccine 2009;27(31):4104-9.
Durbin AP, Setse R, Omer SB, et al. Monitoring adverse events following yellow fever
vaccination using an integrated telephone and Internet-based system. Vaccine 2009;
27:6143-47.
Wright PF, Durbin AP, Whitehead SS, Ikizler MR, Henderson S, Blaney JE, Thumar B,
Ankrah S, Rock MT, McKinney BA, Murphy BR, and Schmidt AC. Phase 1 trial of the
dengue virus type 4 vaccine candidate rDEN4 30-4995 in healhty adult volunteers. Am J
Trop Med Hyg. 2009; 81(5):834-41.
O Connell KA, Su J, Durbin AP, Apuzzo LG, Imteyaz H, Williams TM, Ray SC,
Margolick JB, Silicano RF, and Blankson JN. HIV-1 evolution following transmission to
an HLA-B*5801-positive patient. J Infect Dis. 2009; 200(12):1820-24.
Blaney JE, Jr., Durbin AP, Murphy BR and Whitehead SS. Targeted mutagenesis as a
rational approach to dengue virus vaccine development. Curr Top Microbiol Immunol
2010;338:145-58
Durbin AP, Whitehead SS. Dengue vaccine candidates in development. Curr Top
Microbiol Immunol 2010;338:129-43
Ellis RD, Martin LB, Shaffer D, Long CA, Kazutoyo M, Fay MP, Narum DL, Zhu D,
Mullen GE, Mahanty S, Miller LH, Durbin AP. Phase 1 trial of the Plasmodium
falciparum blood stage vaccine MSP142-C1/alhydrogel with and without CPG 7909 in
malaria na ve adults. PLos One 2010;5(1):e8787
Bookchapters
Vaughn DW, Whitehead SS, Durbin AP, Alan DTB, Lawrence RS. Dengue. Vaccines
for Biodefense and Emerging and Neglected Diseases. London: Academic Press, 2009:
285-324.
Whitehead SS and Durbin AP. 2010. Prospects and challenges for dengue virus vaccine
development. In K. A. Hanley and S. C. Weaver (ed.), Frontiers in Dengue Virus
Research. Caister Academic Press, Portland.
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CURRICULM VITAE
Anna Palmer Durbin
PART II
TEACHING
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Classroom Instruction:
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223.867 Special Topics in Vaccine Science, 2006 present; enrollment 78 students
223.689 The Biological Basis of Vaccine Development, 2002 present; enrollment 54
students
Guest Lecturer
224.686 Vaccine Development and Application (2001 present)
223.682 Clinical Aspects of Tropical Diseases (2000 present)
223.705 Clinical Vaccine Trials: Planning and Implementation (2002 present)
223.867 Vaccine Science and Policy Seminar (2001 2006)
Winter Institute in Tropical Medicine (2003 present)
Summer Institute in Tropical Medicine (2003 - present
020.151 General Biology Workshop, Homewood Campus (2003 present)
260.626 Fundamental Virology (2005)
306.655 Research ethics and Integrity: U.S. and International Issues (2007 present)
180.628 Animals in Research: Law, Policy, and Humane Sciences (2008 - present)
Microbiology 210 course, George Washington University (2008 - present)
Seminar
2004 2008 Co-director: Microbial Immunity and Vaccine Development Research Seminar
RESEARCH GRANT PARTICIPATION
1. Operation of a facility for the testing of malaria vaccines in adult human subjects.
9/30/04 9/29/11. NIAID/NIH. TDC= $9,199,240.
Principal Investigator: Anna Durbin. I am funded from 20 40% depending upon the
activity of the contract.
Objective: To evaluate the safety and immunogenicity of malaria vaccine candidates
targeting the different stages of the malaria parasite. We plan to utilize the --b(4
to develop new assays to characterize the
immune response to malaria antigens. I am the Principal Investigator for trials conducted
under this contract. I develop the clinical protocol and all documents related to the
studies.
Clinical trials ongoing under this contract
Phase 1 Study of the Safety and Immunogenicity of PpPfs25/ISA51 and
ScPvs25/ISA51: Transmission Blocking Vaccines for Plasmodium falciparum and
Plasmodium vivax Malaria
Role: Principal Investigator
Phase 1 Study of the Safety and Immunogenicity of MSP142-C1/Alhydrogel with
and without CPG 7909, an Asexual Blood Stage Vaccine for Plasmodium falciparum
Malaria
Role: Principal Investigator
Phase I Study of the Safety and Immunogenicity of AMA1-C1/Alhydrogel + CPG
7909, an Asexual Blood Stage Vaccine for Plasmodium falciparum Malaria
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Role: Principal Investigator
Phase I study of the Safety and Immunogenicity of BSAM-2/Alhydrogel + CPG
7909, an Asexual Blood Stage Vaccine for Plasmodium falciparum Malaria in Adults
in the US and Mali.
Role: Principal Investigator
2. Operation of a facility for the study of infectious agents, vaccines and antimicrobials
in adults and pediatric human subjects. 4/1/09-3/31/14. NIH/NIAID. $31,593,088.
Principal Investigator: Ruth Karron.
Funding level: 40 80%
Individual Role: Co-principal investigator of this contract. I am the Principal
Investigator for phase I flavivirus vaccine trials conducted under this contract, and for
direction of the flavivirus laboratory at the Center for Immunization Research.
Objective: To evaluate the safety and immunogenicity of novel live attenuated vaccines
for the prevention of flavivirus infections and to use these studies as a model for primary
flavivirus infection to better understand the immunopathogenesis of flavivirus-related
disease.
3. Operation of a facility for the study of infectious agents, vaccines and antimicrobials in
adults and pediatric human subjects. 7/1/01-3/31/09. NIH/NIAID. $21,764,263.
Principal Investigator: Ruth Karron.
Funding level: 40 60%
Individual Role: Co-principal investigator. I am the Principal Investigator for phase I
flavivirus vaccine trials conducted under this contract, and for direction of the flavivirus
laboratory at the Center for Immunization Research.
Objective: To evaluate the safety and immunogenicity of novel live attenuated vaccines
for the prevention of flavivirus infections and to use these studies as a model for primary
flavivirus infection to better understand the immunopathogenesis of flavivirus-related
disease.
Clinical trials currently ongoing under this contract:
Safety and Immunogenicity of a 2-Dose Regimen of rDEN1 30 Dengue Serotype 1
Vaccine with Boosting at 4 versus 6 Months
Role: Principal Investigator
Safety and Immunogenicity of a 2-Dose Regimen of rDEN2/4 30(ME) Dengue
Serotype 2 Vaccine with Boosting at 4 versus 6 Months
Role: Principal Investigator
A Phase I Dose Comparison Study of the Safety and Immunogenicity of rDEN3
3 D4 30, a Live Attenuated Virus Vaccine Candidate for the Prevention of Dengue
Serotype 3
Role: Principal Investigator
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Phase 1 Study of the Safety and Immunogenicity of a 2-Dose Regimen of West
Nile/Dengue 4-3 30 Chimeric Virus Vaccine (WN/DEN4 30), a Live Attenuated
Vaccine for West Nile Encephalitis
Role: Principal Investigator
A Phase I Dose Comparison Study of the Safety and Immunogenicity of
rDEN3 30/31-71643, a Live Attenuated Virus Vaccine Candidate for the Prevention
of Dengue Serotype 3
Role: Principal Investigator
Phase I evaluation of the safety and immunogenicity of rDEN4 30 Lot# 109A, a live
attenuated DEN4 vaccine in healthy flavivirus-na ve adult volunteers.
Role: Principal Investigator
4. Rhesus macaque model for dengue, dengue hemorrhagic fever/shock syndrome.
9/1/04 9/1/08. Pediatric Dengue Vaccine Initiative. TDC= b)(4)(b)(6
Principal Investigator: Anna Durbin.
Funding level: 10%
Objective: Development of an animal model for dengue disease utilizing the rhesus
macaque. A reproducible animal model of dengue illness will be extremely useful in the
development and implementation of a dengue vaccine program.
5. Career Development Award - Regional Center for Excellence for Biodefense and
Emerging Infectious Diseases Research, 9/1/03 9/1/06, NIAID/NIH UAI057168A.
TDC= $300,000 .
Principal Investigator (for Career Development award): Anna Durbin.
Role: Develop as a clinical investigator by conducting clinical trials of novel vaccines.
40%
Funding Level:
I am utilizing the dengue vaccine trials that I am conducting to study
Objective:
infection by vaccine virus as a model for asymptomatic primary dengue infection. We
hope to characterize the humoral and cellular responses to infection with vaccine virus
and correlate these findings with symptomatic disease in natural infection.
Principal Responsibilities: Principal investigator of clinical trials. In addition, I
conducted a sub-study evaluating skin biopsies of subjects enrolled in dengue vaccine
trials to determine if skin cells were target cells of dengue virus and, if so, which specific
cells supported dengue virus replication.
6. Center for Immunization Safety Assessment (CISA) CDC
Principal Investigator: Neal Halsey
Role: Investigator. I provide support to this grant as an Infectious Diseases Specialist
with expertise in flavivirus infections. I provide consultation for the identification and
evaluation of adverse events related to yellow fever vaccination.
Funding Level: 0%
Objective: The CISA network is comprised of clinical academic centers in
partnership with the Centers for Disease Control and Prevention (CDC) and serves as a
source of clinical expertise in evaluating and treating adverse events following
immunization.
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Principal Responsibilities: Investigate cases of yellow fever vaccine-associated
viscerotropic disease. I wrote the protocol for these investigations and collected data on
cases reported to the CDC.
Development of an Animal Model for Dengue Infection/Dengue Hemorrhagic
Fever and Dengue Shock Syndrome. 2001. Faculty Innovation Fund, BSPH.
Role: Principal Investigator
Funding level: 0%
Objective: Perform preliminary studies in preparation of developing a macaque model of
dengue disease.
ACADEMIC SERVICE
Department of International Health
2006 - 2009: Faculty Budget Advisory Committee
2006 present: Coordinator of the Vaccine Policy Certificate Program
2001 2002: Vaccines for Bioterrorism Working Group
Search Committee Member for the recruitment of a tenure track faculty member to head
the b)(4 Cellular Immunology Laboratory in the Department of International
Health
Johns Hopkins University
2009 present : Member of the search committed for the Associate Provost for
Animal Research and Resources at Johns Hopkins University
2002 - present: Member- Animal Care and Use Committee,
1999 present: Active Staff, Department of Medicine, Division of Infectious
Diseases, The Johns Hopkins Hospital
PRESENTATIONS
Scientific Meetings
Infectious Diseases Society of America, Presenter
2002: Intranasal Immunization with Proteosome-Shigella flexneri 2A LPS Vaccine:
Factors Associated with Protection in a Volunteer Challenge Model
2009: Invited Speaker, Update on live attenuated dengue virus vaccines
American Society for Tropical Medicine, Presenter
2003: A novel dengue 4 vaccine: 2A 30
2005: Phase I trial of rDEN1 30, a live attenuated DEN1 vaccine
2006: rDEN2/4 30(ME), a live attenuated DEN2 vaccine
2006: Phenotyping of PBMCs infected by dengue virus in pediatric cases
2007: Phase I study of the safety and immunogenicity of rDEN4 30-200,201; a live
attenuated virus vaccine candidate
2008: NIH/LID Dengue vaccines, symposium presentation.
2009: Safety and Immunogenicity of a 2-Dose Regimen of rDEN1 30 Dengue Serotype
1 Vaccine with Boosting at 4 versus 6 Months
International Congress of Virology, Presenter
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2008: Immunization with a heterologous live attenuated dengue vaccine months to years
after primary DENV immunization
Pediatric Dengue Vaccine Initiative Annual Meeting, Presenter
2006: The rhesus macaque model of DF/DHF/DSS
2007: The rhesus macaque model of DF/DHF/DSS
2008: Immunization with a live attenuated heterologous DENV vaccine months to years
after primary DENV immunization preliminary data.
2009: Immunization with a live attenuated heterologous DENV vaccine months to years
after primary DENV immunization Final data.
2009: The rhesus macaque model of DF/DHF/DSS further studies
2008: Organizer and participant in the NIAID workshop on dengue animal models
American Society of Microbiology
2010: Invited Speaker, Live attenuated dengue virus vaccines
ADDITIONAL INFORMATION
Research and Research Objectives
My primary area of research interest is the immunopathogenesis of dengue hemorrhagic
fever, dengue shock syndrome. Through our intensive studies of volunteers immunized
with experimental, monotypic, live attenuated dengue vaccines, we have begun
characterizing the virologic and immunologic response to these vaccines as a model of
primary dengue infection. As a sub-study of these vaccine trials, we have identified
dengue virus in epidermal dendritic cells of skin biopsy specimens from our vaccinees. I
hope to be able to identify cellular targets of dengue infection by analyzing the skin
biopsies of dengue vaccine recipients and determining the origin of these epidermal
dendritic cells and hopefully, how and why they have migrated to the skin. In addition,
we have characterized the phenotype of PBMCs obtained from patients during acute
dengue infections and demonstrated that monocytes are activated during acute dengue
infection and that the expression of these activation markers can correlate with disease
severity. We plan to characterize the marker and cytokine expression of PBMCs
obtained from the subjects enrolled in our vaccine trials and attempt to determine if
cytokine expression patterns correlate with quality of the antibody response to these
exciting vaccine candidates. Through my PDVI grant I am developing a rhesus macaque
model for severe dengue disease. This model has demonstrated a robust response of the
reticuloendothelial system of the macaque to secondary dengue infection and has
suggested that the interval between primary and secondary dengue infection is critical to
the development of severe disease.
Keywords: dengue, vaccine, clinical trials, dengue hemorrhagic fever/shock syndrome,
immunopathology
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