Julie E. Ledgerwood, D.O.

Julie E Ledgerwood, D.O.

Credit: NIAID
Deputy Director
Chief Medical Officer
Chief, Clinical Trials Program

Major Areas of Research

  • Clinical evaluation of candidate vaccines and monoclonal antibodies targeting HIV, Influenza, Ebola, Zika, Chikungunya, Malaria, and other emerging infectious diseases
  • Translational immunology and vaccine research
  • Advanced clinical development including strategic planning, facilitation, support, implementation and oversight of external clinical trials​

View all research conducted at the Vaccine Research Center (VRC)

Program Description

The VRC conducts basic, translational, and clinical research. The primary mission of the VRC Clinical Trials Program (CTP) is to carry out the clinical research component of this triad both through intramural conduct of clinical trials at the NIH Clinical Center and through a broad range of support for external trials conducted by VRC collaborators and partners. These trials include evaluation of candidate vaccines and monoclonal antibodies targeting HIV, influenza, and other emerging infections. A secondary mission of the CTP is to conduct translational immunology research.

Since 2001, the CTP has launched over 70 research protocols involving candidate vaccines and monoclonal antibodies targeting HIV, smallpox, influenza, West Nile virus, Ebola, Marburg, severe acute respiratory syndrome (SARS), malaria, chikungunya, and Zika involving over 10,000 clinical trial volunteer enrollments.

The CTP has also advanced vaccine candidates into both domestic and international Phase Ib, II, and IIb trials. Advanced product development and larger clinical trials require partnership with external clinical trial networks operated or supported by other federal agencies, academia, non-profit organizations, or the private sector. The CTP plays an important role in the planning, conduct, oversight, and analysis of external network clinical trials.

Featured Research

DNA Vaccine Approach

DNA Vaccine Approach

Credit
AS Fauci/NIAID
VRC DNA Vaccines for Emerging Infections

VRC DNA Vaccines for Emerging Infections

Credit
J. Ledgerwood/NIAID VRC

 

Biography

Julie E. Ledgerwood, D.O., is the Deputy Director, Chief Medical Officer, and Chief of the Clinical Trials Program for the Vaccine Research Center, NIAID. Dr. Ledgerwood has 16 years of clinical research experience and is responsible for VRC clinical research strategic planning, research activities, regulatory strategy, compliance and regulatory operations. She leads a team of 64 clinical researchers and regulatory experts and has conducted more than 60 Phase 1-2b clinical trials studying vaccines and monoclonal antibodies targeting pathogens such as HIV, influenza, Ebola, malaria, Chikungunya, and Zika in over 13 countries. She has authored more than 85 publications and received numerous awards for her work.  Dr. Ledgerwood completed her internship at Oklahoma State University Medical Center, residency in internal medicine at Johns Hopkins Bayview Medical Center in Baltimore and fellowship in allergy and immunology at the NIH. She is board-certified in allergy and immunology by the American Board of Allergy and Immunology.

Research Group

Morgan Anderson, B.S.
Intramural Research Fellow (IRTA)

Charla A. Andrews, Sc.M., M.S. (RAC-US)
Scientific Advisor

Preeti J. Apte, M.H.A.
Recruitment and Outreach Specialist

Anita Arthur R.N., B.S.N.
Clinical Research Nurse

Seemal Awan, M.D.
Clinical Fellow

Allison Beck, PA-C
Medical Officer

Nina Berkowitz, M.P.H.
Team Lead Protocol Operations

Catina R. Evans, C.P.T., R.M.A, C.A.N.
Clinical Research Technician/Phlebotomist

Maria Claudia Burgos Florez, M.Sc.
Protocol Specialist

Christian Buettner, Ph.D.
Protocol Specialist

Emily Coates, Ph.D.
Director of Translational Science

Pamela Costner, R.N., B.S.N., C.D.E.
Research Nurse/Study Coordinator

Jennifer Cunningham, B.S.N.
Research Nurse

Aba Mensima Eshun, R.N., B.S.N.
Research Nurse

LCDR Martin Gaudinski, M.D.
Medical Director

Ingelise Gordon, R.N.
Clinical Operations Manager

Carmencita Graves, M.Sc, M.B.A.
Management Analyst

Mercy Guech, Ph.D.
​​Scientific Advisor

Myra Happe, Ph.D.
Scientific Advisor

Renunda T. Hicks
Recruitment & Outreach Specialist

LaSonji Holman, R.N., M.S.N., F.N.P.
Nurse Practitioner

Katherine Houser, Ph.D.
Senior Scientific Advisor

Justine N. Jones, B.S.
Intramural Research Fellow (IRTA)

Lam Ngan Le, M.B.A., C.C.R.P.
IRB specialist​

Lauren Lizewski, M.P.H.
Management Analyst

Floreliz Mendoza, R.N.
Research Nurse/Study Coordinator

Patricia Morgan, P.A., M.Sc.
Oversight Monitor

Thuy A. Nguyen, B.S.
Clinical Data Management Associate 

Laura Novik, R.N., B.S.N., M.A.
Senior Study Coordinator

Mark O’Callahan, B.S.
Project Manager

Abidemi Ola, R.N., M.S.N., F.N.P.
Nurse Practitioner

Karen M. Parker, D.N.P., C.R.N.P., F.N.P.-B.C.
Nurse Practitioner

Iris R. Pittman, B.A., C.C.R.P.
IRB Specialist

Sarah H. Plummer, R.N., M.S.N., N.P.
Chief, Clinical Development Unit

Ro Shauna S. Rothwell, Ph.D.
Protocol Specialist

Jamie Saunders, R.N., B.S.N.
Research Nurse/Study Coordinator

Ellie Seo, R.Ph., Ph.D., R.A.C. (Drug)
Scientific Advisor

Sandra Sitar, M.S.
Director of Strategic Communications

Stephanie Taylor, B.A.
Management Analyst

Shinyi Telscher, Pharm.D., C.C.R.P.
Clinical Trials Pharmacist

Olga Trofymenko, M.D.
Oversight Monitor

Olga Vasilenko, M.S., C.C.R.P.
Clinical Research Information Specialist

Sana Waheed, M.S.
Protocol Specialist 

Xiaolin Wang, R.N., B.S.N.
Clinical Research Nurse

William Whalen, R.N., B.S.N.
Research Nurse

Alicia T. Widge, M.D.
Associate Chief for Clinical Research and Development 

Pernell V. Williams
Clinical Operations Research Assistant

LCDR Richard Wu, M.D.
Clinical Fellow

Galina Yamshchikov, M.S.
Senior Project Manager​

 

Selected Publications

Gaudinski MR, Coates EE, Novik L, Widge A, Houser KV, Burch E, Holman LA, Gordon IJ, Chen GL, Carter C, Nason M, Sitar S, Yamshchikov G, Berkowitz N, Andrews C, Vazquez S, Laurencot C, Misasi J, Arnold F, Carlton K, Lawlor H, Gall J, Bailer RT, McDermott A, Capparelli E, Koup RA, Mascola JR, Graham BS, Sullivan NJ, Ledgerwood JE; VRC 608 Study team. Safety, tolerability, pharmacokinetics, and immunogenicity of the therapeutic monoclonal antibody mAb114 targeting Ebola virus glycoprotein (VRC 608): an open-label phase 1 study. Lancet. 2019 Jan 24.

Gaudinski MR, Houser KV, Morabito KM, Hu Z, Yamshchikov G, Rothwell RS, Berkowitz N, Mendoza F, Saunders JG, Novik L, Hendel CS, Holman LA, Gordon IJ, Cox JH, Edupuganti S, McArthur MA, Rouphael NG, Lyke KE, Cummings GE, Sitar S, Bailer RT, Foreman BM, Burgomaster K, Pelc RS, Gordon DN, DeMaso CR, Dowd KA, Laurencot C, Schwartz RM, Mascola JR, Graham BS, Pierson TC, Ledgerwood JE, Chen GL; VRC 319; VRC 320 study teams. Safety, tolerability, and immunogenicity of two Zika virus DNA vaccine candidates in healthy adults: randomised, open-label, phase 1 clinical trials. Lancet. 2017 Dec 4.

Lynch RM, Boritz E, Coates EE, DeZure A, Madden P, Costner P, Enama ME, Plummer S, Holman L, Hendel CS, Gordon I, Casazza J, Conan-Cibotti M, Migueles SA, Tressler R, Bailer RT, McDermott A, Narpala S, O'Dell S, Wolf G, Lifson JD, Freemire BA, Gorelick RJ, Pandey JP, Mohan S, Chomont N, Fromentin R, Chun TW, Fauci AS, Schwartz RM, Koup RA, Douek DC, Hu Z, Capparelli E, Graham BS, Mascola JR, Ledgerwood JE; VRC 601 Study Team. Virologic effects of broadly neutralizing antibody VRC01 administration during chronic HIV-1 infection. Sci Transl Med. 2015 Dec 23;7(319):319ra206.  

Ledgerwood JE, Coates EE, Yamshchikov G, Saunders JG, Holman L, Enama ME, DeZure A, Lynch R, Gordon I, Plummer S, Hendel CS, Pegu A, Conan-Cibotti M, Sitar S, Bailer RT, Narpala S, McDermott A, Louder M, O'Dell S, Mohan S, Pandey JP, Schwartz RM, Hu Z, Koup RA, Capparelli E, Mascola JR, Graham BS; VRC 602 Study Team. Safety, Pharmacokinetics, and Neutralization of the Broadly Neutralizing HIV-1 Human Monoclonal Antibody VRC01 in Healthy Adults. Clin Exp Immunol. 2015 Dec;182(3):289-301.

Chang LJ, Dowd KA, Mendoza FH, Saunders JG, Sitar S, Plummer SH, Yamshchikov G, Sarwar UN, Hu Z, Enama ME, Bailer RT, Koup RA, Schwartz RM, Akahata W, Nabel GJ, Mascola JR, Pierson TC, Graham BS, Ledgerwood JE; VRC 311 Study Team. Safety and tolerability of chikungunya virus-like particle vaccine in healthy adults: a phase 1 dose-escalation trial. Lancet. 2014 Dec 6;384(9959):2046-52.

Ledgerwood JE, DeZure AD, Stanley DA, Novik L, Enama ME, Berkowitz NM, Hu Z, Joshi G, Ploquin A, Sitar S, Gordon IJ, Plummer SA, Holman LA, Hendel CS, Yamshchikov G, Roman F, Nicosia A, Colloca S, Cortese R, Bailer RT, Schwartz RM, Roederer M, Mascola JR, Koup RA, Sullivan NJ, Graham BS; the VRC 207 Study Team. Chimpanzee Adenovirus Vector Ebola Vaccine - Preliminary ReportN Engl J Med. 2014 Nov 26.

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