Clinical Trials Program
Lesia Dropulic, M.D.
Chief, Clinical Trials Program
Contact: For contact information, search the NIH Enterprise Directory.
- Clinical evaluation of candidate vaccines and monoclonal antibodies targeting HIV, Influenza, Ebola, Zika, Chikungunya, Malaria, SARS-CoV-2 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 14,000 clinical trial volunteer enrollments.
The CTP has also advanced vaccine candidates into both domestic and international phase 1b, 2, 2b, and phase 3 efficacy 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.
Biography
Education
M.D., Wayne State University School of Medicine
Lesia K. Dropulic, M.D. is the Chief of the Clinical Trials Program of the Vaccine Research Center. Dr. Dropulic has 13 years of clinical research experience and is responsible for VRC clinical research activities and operations. She leads a team of 52 clinical researchers who have experience conducting clinical trials studying vaccines and monoclonal antibodies targeting such pathogens as HIV, influenza, Ebola, malaria, chikungunya, Zika, and SARS-CoV-2. Dr. Dropulic completed her residency in Internal Medicine at Washington University School of Medicine and her fellowship in Infectious Diseases at Johns Hopkins University School of Medicine, where she remained on faculty and served as attending physician for the Infectious Diseases consult service, for patients living with HIV/AIDS, and co-directed the Transplant Infectious Diseases service at Johns Hopkins Hospital. Dr. Dropulic was a staff clinician in the Laboratory of Infectious Diseases in the Division of Intramural Research prior to joining the VRC.
Selected Publications
Gaudinski MR, Berkowitz NM, Idris AH, Coates EE, Holman LSA, Mendoza F, Gordon IJ, Plummer SH, Trofymenko O, Hu Z, Campos Chagas A, O’Connell S, Basappa M, Douek N, Narpala SR, Barry CR, Widge AT, Hicks R, Awan SF, Wu RL, Hickman S, Wycuff JA, Stein JA, Case C, Evans BP, Carlton K, Gall JG, Vazquez S, Flach B, Chen GL, Francica JR, Flymm BJ, Kisalu NK, Capparelli EV, McDermott A, Mascola JR, Ledgerwood JE, Seder RA. A Monoclonal Antibody for Malaria Prevention. N Eng J Med. 2021 Aug 11.
Widge AT, Rouphael NG, Jackson LA, Anderson EJ, Roberts PC, Makhene M, Chappell JD, Denison MR, Stevens LJ, Pruijssers AJ, McDermott AB, Flach B, Lin BC, Doria-Rose NA, O'Dell S, Schmidt SD, Neuzil KM, Bennett H, Leav B, Makowski M, Albert J, Cross K, Edara VV, Floyd K, Suthar MS, Buchanan W, Luke CJ, Ledgerwood JE, Mascola JR, Graham BS, Beigel JH; mRNA-1273 Study Group. Durability of Responses after SARS-CoV-2 mRNA-1273 Vaccination. N Engl J Med. 2021 Jan 7;384(1):80-82.
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 Mar 2;393(10174):889-898.
Gaudinski MR, Houser KV, Doria-Rose NA, Chen GL, Rothwell RSS, Berkowitz N, Costner P, Holman LA, Gordon IJ, Hendel CS, Kaltovich F, Conan-Cibotti M, Gomez Lorenzo M, Carter C, Sitar S, Carlton K, Gall J, Laurencot C, Lin BC, Bailer RT, McDermott AB, Ko SY, Pegu A, Kwon YD, Kwong PD, Namboodiri AM, Pandey JP, Schwartz R, Arnold F, Hu Z, Zhang L, Huang Y, Koup RA, Capparelli EV, Graham BS, Mascola JR, Ledgerwood JE; VRC 605 study team. Safety and pharmacokinetics of broadly neutralising human monoclonal antibody VRC07-523LS in healthy adults: a phase 1 dose-escalation clinical trial.
Lancet HIV. 2019 Oct;6(10):e667-e679. doi: 10.1016/S2352-3018(19)30181-X. Epub 2019 Aug 28.
Crank MC, Ruckwardt TJ, Chen M, Morabito KM, Phung E, Costner PJ, Holman LA, Hickman SP, Berkowitz NM, Gordon IJ, Yamshchikov GV, Gaudinski MR, Kumar A, Chang LA, Moin SM, Hill JP, DiPiazza AT, Schwartz RM, Kueltzo L, Cooper JW, Chen P, Stein JA, Carlton K, Gall JG, Nason MC, Kwong PD, Chen GL, Mascola JR, McLellan JS, Ledgerwood JE, Graham BS; VRC 317 Study Team.Science. A proof of concept for structure-based vaccine design targeting RSV in humans. Science. 2019 Aug 2;365(6452):505-509.
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.
Research Group
Morgan Anderson, B.S.
Intramural Research Fellow (IRTA)
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.
Director, 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
Lesia Dropulic, M.D.
Chief, Clinical Trials Program
Olympia Hotobah-During
Intramural Research Fellow (IRTA)
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
Amelia Hofstetter, Ph.D.
Scientific Advisor
LaSonji Holman, R.N., M.S.N., F.N.P.
Nurse Practitioner
Katherine Houser, Ph.D.
Senior Scientific Advisor
Justine N. Jones, B.S.
Clinical Research QC & Recruitment Associate
Priya Kamath, M.D.
Medical Officer
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
Lashawn Requilman
Recruitment & Outreach Specialist
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
Larisa Strom, MPH
Scientific Program Analyst
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
Nicole Webb, L.P.N., M.Sc.
Quality Program Manager
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 Protocol Specialist