Julie E. Ledgerwood, D.O.
Clinical Trials Core
10 Center Drive
Bethesda, MD 20892
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 45 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 9,000 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.
Julie E. Ledgerwood, D.O., is the Chief of the Clinical Trials Program at the Vaccine Research Center, NIAID. She leads clinical trials and clinical collaborations for the VRC; and has served as Principal Investigator, Protocol Chair, or Associate Investigator for over 40 Phase I and II IND clinical trials studying vaccines and monoclonal antibodies targeting HIV, influenza, Ebola, malaria, Chikungunya, Zika and other emerging infectious diseases. For this work she has received numerous awards including three NIH Director's awards. She completed a residency in internal medicine at Johns Hopkins Bayview Medical Center and a fellowship in allergy and immunology at the NIH. She is a graduate of Phillips University and the Oklahoma State University Center for Health Sciences, College of Osteopathic Medicine and is board-certified in allergy and immunology by the American Board of Allergy and Immunology.
Ledgerwood JE, Zephir K, Hu Z, Wei CJ, Chang L, Enama ME, Hendel CS, Sitar S, Bailer RT, Koup RA, Mascola JR, Nabel GJ, Graham BS, VRC 310 Study Team. Prime-boost interval matters: a randomized phase 1 study to identify the minimum interval necessary to observe the H5 DNA influenza vaccine priming effect. J Infect Dis. 2013;208(3):418-22.
Ledgerwood JE. AS03-adjuvanted influenza vaccine in elderly people. Lancet Infect Dis. 2013;13(6):466-7.
Ledgerwood JE, Wei CJ, Hu Z, Gordon IJ, Enama ME, Hendel CS, McTamney PM, Pearce MB, Yassine HM, Boyington JC, Bailer R, Tumpey TM, Koup RA, Mascola JR, Nabel GJ, Graham BS, VRC 306 Study Team. DNA priming and influenza vaccine immunogenicity: two phase 1 open label randomised clinical trials. Lancet Infect Dis. 2011;11(12):916-24.
Ledgerwood JE, Pierson TC, Hubka SA, Desai N, Rucker S, Gordon IJ, Enama ME, Nelson S, Nason M, Gu W, Bundrant N, Koup RA, Bailer RT, Mascola JR, Nabel GJ, Graham BS, VRC 303 Study Team. A West Nile virus DNA vaccine utilizing a modified promoter induces neutralizing antibody in younger and older healthy adults in a phase I clinical trial. J Infect Dis. 2011;203(10):1396-404.
Nabel GJ, Wei CJ, Ledgerwood JE. Vaccinate for the next H2N2 pandemic now. Nature. 2011;471(7337):157-8.
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This page was last updated on March 27th, 2017