Julie E. Ledgerwood, D.O.

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​

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 50 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
Credit: AS Fauci/NIAID

DNA Vaccine Approach

VRC DNA Vaccines for Emerging Infections
Credit: J. Ledgerwood/NIAID VRC

VRC DNA Vaccines for Emerging Infections

 

Biography

Julie E. Ledgerwood, D.O., is the Chief of the Clinical Trials Program at the Vaccine Research Center, NIAID. She leads domestic and international clinical trials and clinical collaborations for the VRC; and has served as Principal Investigator, Protocol Chair, or Associate Investigator for over 50 Phase I and II clinical trials studying vaccines and monoclonal antibodies targeting HIV, influenza, Ebola, malaria, Chikungunya, Zika, RSV and other emerging infectious diseases. For this work she has received numerous awards including four 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.

Research Group

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

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

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

Maria Claudia Burgos Florez, M.Sc.
Protocol Specialist

Grace Chen, M.D.
Associate Chief of Clinical Trial Operations

Emily Coates, Ph.D.
Scientist

Josephine Cox, Ph.D.
Clinical Laboratory Coordinator

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

Jennifer Cunningham, B.S.N.
Research Nurse

Martin Gaudinski, M.D.
Clinical Fellow

Ingelise Gordon, R.N.
Clinical Operations Manager

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

Mercy Guech, Ph.D.
​​Scientific Advisor

Cynthia Starr Hendel, C.R.N.P., C.C.R.C.
Nurse Practitioner

Renunda T. Hicks
Recruitment & Outreach Specialist

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

Brenda D. Larkin, R.N., B.S.N., C.C.R.C.
Strategic Advisor for Special Projects

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

Carol Levinson, R.N., B.S.N, C.M.S.R.N.
Research Nurse​

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

Laura Novik, R.N., B.S.N., M.A.
HIV Vaccine Studies Coordinator

Abidemi Ola, R.N., MSN., F.N.P.
Nurse Practitioner

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

Sarah H. Plummer, R.N., M.S.N., N.P.
Senior Nurse Practitioner and Medical Officer

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

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

Sandra Sitar, M.S.
Director of Communications and Public Affairs

Stephanie Taylor, B.A.
Management Analyst

Cora Trelles Cartagena, B.S.W.
Recruitment and Outreach Specialist​

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

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

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

Pernell V. Williams
Clinical Operations Research Assistant

Galina Yamshchikov, M.S.
Senior Project Manager​

 

Selected Publications

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.

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.

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.

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.

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Content last reviewed on February 1, 2018