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 42 research protocols involving candidate vaccines and monoclonal antibodies targeting HIV, smallpox, influenza, West Nile virus, Ebola, Marburg, severe acute respiratory syndrome (SARS), malaria, and chikungunya, enrolling over 6,000 volunteers. The CTP engages in efforts aimed at efficient vaccine clinical research practice (PDF).
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 interpretation of external network clinical trials.
For updates on VRC scientific progress, visit Influenza Vaccine Development
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 35 Phase I and II IND clinical trials studying vaccines and monoclonal antibodies targeting HIV, influenza, Ebola, malaria, Chikungunya, and other emerging infectious diseases. After completing a residency in internal medicine at Johns Hopkins Bayview Medical Center in Baltimore in 2002, Dr. Ledgerwood joined NIAID as a clinical fellow in allergy and immunology. In 2003, she joined the VRC as a clinical investigator. Dr. Ledgerwood is board-certified in allergy and immunology by the American Board of Allergy and Immunology. She is a graduate of Phillips University and the Oklahoma State University Center for Health Sciences, College of Osteopathic Medicine.
Recruitment and Outreach Specialist
Associate Chief for Protocol Operations
Research Nurse/Study Coordinator
Clinical Operations Manager
Strategic Advisor for Special Projects
HIV Vaccine Studies Coordinator
Senior Nurse Practitioner
Director of Communications and Public Affairs
Clinical Research Information Specialist
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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 Report. N Engl J Med. 2014 Nov 26.
Kibuuka H, Berkowitz NM, Millard M, Enama ME, Tindikahwa A, Sekiziyivu AB, Costner P, Sitar S, Glover D, Hu Z, Joshi G, Stanley D, Kunchai M, Eller LA, Bailer RT, Koup RA, Nabel GJ, Mascola JR, Sullivan NJ, Graham BS, Roederer M, Michael NL, Robb ML, Ledgerwood JE; the RV 247 Study Team. Safety and immunogenicity of Ebola virus and Marburg virus glycoprotein DNA vaccines assessed separately and concomitantly in healthy Ugandan adults: a phase 1b, randomised, double-blind, placebo-controlled clinical trial. Lancet. 2014 Dec 22.
Sarwar UN, Costner P, Enama ME, Berkowitz N, Hu Z, Hendel CS, Sitar S, Plummer S, Mulangu S, Bailer RT, Koup RA, Mascola JR, Nabel GJ, Sullivan NJ, Graham BS, Ledgerwood JE; VRC 206 Study Team. Safety and immunogenicity of DNA vaccines encoding ebolavirus and marburgvirus wild-type glycoproteins in a phase I clinical trial. J Infect Dis. 2015 Feb 15;211(4):549-57.
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.
Seder RA, Chang LJ, Enama ME, Zephir KL, Sarwar UN, Gordon IJ, Holman LA, James ER, Billingsley PF, Gunasekera A, Richman A, Chakravarty S, Manoj A, Velmurugan S, Li M, Ruben AJ, Li T, Eappen AG, Stafford RE, Plummer SH, Hendel CS, Novik L, Costner PJ, Mendoza FH, Saunders JG, Nason MC, Richardson JH, Murphy J, Davidson SA, Richie TL, Sedegah M, Sutamihardja A, Fahle GA, Lyke KE, Laurens MB, Roederer M, Tewari K, Epstein JE, Sim BK, Ledgerwood JE, Graham BS, Hoffman SL; VRC 312 Study Team. Protection against malaria by intravenous immunization with a nonreplicating sporozoite vaccine. Science. 2013 Sep 20;341(6152):1359-65.
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 Aug 1;208(3):418-22.
Last Updated April 04, 2016