Clinical Trials Program
Major Areas of Research
- 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 (CTP) in the Vaccine Research Center. Dr. Dropulic has more than 15 years of clinical research experience and has oversight over VRC clinical research activities and operations in the CTP. She leads a team of ~ 50 clinical researchers and support staff who design, develop, and conduct clinical trials evaluating vaccines and monoclonal antibodies targeting pathogens, such as HIV, influenza, Ebola, malaria, chikungunya, Zika, SARS-CoV-2, and Nipah virus. Dr. Dropulic completed her residency in Internal Medicine at Washington University School of Medicine and her fellowship training in Infectious Diseases at Johns Hopkins University School of Medicine, where she remained on faculty and served as attending physician for the general Infectious Diseases consult service and for patients living with HIV/AIDS. She also co-developed and co-directed the Transplant Infectious Diseases service at Johns Hopkins Hospital. Dr. Dropulic was a Staff Clinician in the Medical Virology Section of the Laboratory of Infectious Diseases in the Division of Intramural Research prior to joining the VRC.
Selected Publications
Widge AT, Hofstetter AR, Houser KV, Awan SF, Chen GL, Burgos Florez MC, Berkowitz NM, Mendoza F, Hendel CS, Holman LA, Gordon IJ, Apte P, Liang CJ, Gaudinski MR, Coates EE, Strom L, Wycuff D, Vazquez S, Stein JA, Gall JG, Adams WC, Carlton K, Gillespie RA, Creanga A, Crank MC, Andrews SF, Castro M, Serebryannyy LA, Narpala SR, Hatcher C, Lin BC, O'Connell S, Freyn AW, Rosado VC, Nachbagauer R, Palese P, Kanekiyo M, McDermott AB, Koup RA, Dropulic LK, Graham BS, Mascola JR, Ledgerwood JE; VRC 321 study team. An influenza hemagglutinin stem nanoparticle vaccine induces cross-group 1 neutralizing antibodies in healthy adults. Sci Transl Med. 2023 Apr 19.
Andrews SF, Cominsky LY, Shimberg GD, Gillespie RA, Gorman J, Raab JE, Brand J, Creanga A, Gajjala SR, Narpala S, Cheung CSF, Harris DR, Zhou T, Gordon I, Holman L, Mendoza F, Houser KV, Chen GL, Mascola JR, Graham BS, Kwong PD, Widge A, Dropulic LK, Ledgerwood JE, Kanekiyo M, McDermott AB. An influenza H1 hemagglutinin stem-only immunogen elicits a broadly cross-reactive B cell response in humans. Sci Transl Med. 2023 Apr 19.
Lyke KE, Berry AA, Mason K, Idris AH, O'Callahan M, Happe M, Strom L, Berkowitz NM, Guech M, Hu Z, Castro M, Basappa M, Wang L, Low K, Holman LA, Mendoza F, Gordon IJ, Plummer SH, Trofymenko O, Strauss KS, Joshi S, Shrestha B, Adams M, Chagas AC, Murphy JR, Stein J, Hickman S, McDougal A, Lin B, Narpala SR, Vazquez S, Serebryannyy L, McDermott A, Gaudinski MR, Capparelli EV, Coates EE, Wu RL, Ledgerwood JE, Dropulic LK, Seder RA; VRC 612 Part C Study Team. Low-dose intravenous and subcutaneous CIS43LS monoclonal antibody for protection against malaria (VRC 612 Part C): a phase 1, adaptive trial. Lancet Infect Dis. 2023 May.
Wu RL, Idris AH, Berkowitz NM, Happe M, Gaudinski MR, Buettner C, Strom L, Awan SF, Holman LA, Mendoza F, Gordon IJ, Hu Z, Campos Chagas A, Wang LT, Da Silva Pereira L, Francica JR, Kisalu NK, Flynn BJ, Shi W, Kong WP, O'Connell S, Plummer SH, Beck A, McDermott A, Narpala SR, Serebryannyy L, Castro M, Silva R, Imam M, Pittman I, Hickman SP, McDougal AJ, Lukoskie AE, Murphy JR, Gall JG, Carlton K, Morgan P, Seo E, Stein JA, Vazquez S, Telscher S, Capparelli EV, Coates EE, Mascola JR, Ledgerwood JE, Dropulic LK, Seder RA; VRC 614 Study Team. Low-Dose Subcutaneous or Intravenous Monoclonal Antibody to Prevent Malaria. N Engl J Med. 2022 Aug 4.
Cohen JI, Dropulic L, Wang K, Gangler K, Morgan K, Liepshutz K, Krogmann T, Ali MA, Qin J, Wang J, Vogel JS, Lei Y, Suzuki-Williams LP, Spalding C, Palmore TN, Burbelo PD. Comparison of levels of nasal, salivary, and plasma antibody to SARS-CoV-2 during natural infection and after vaccination. Clin Infect Dis. 2023 Apr 17.
Dropulic LK, Oestreich MC, Pietz HL, Laing KJ, Hunsberger S, Lumbard K, Garabedian D, Turk SP, Chen A, Hornung RL, Seshadri C, Smith MT, Hosken NA, Phogat S, Chang L-J, Koelle DM, Wang K, Cohen JI. A randomized, double-blind, placebo-controlled, phase 1 study of a replication-defective herpes simplex virus 2 vaccine, HSV529, in Adults with and Without HSV Infection. J Infect Dis. 2019 Aug 9.
Research Group
Ingelise Gordon
Clinical Operations Manager of the Vaccine Evaluation Clinic
LaSonji Holman
Deputy Clinical Operations Manager and Chief Safety Officer
Galina Yamshchikov
Director of Protocol Operations
Sarah Plummer
Chief of the Advanced Clinical Development Unit
Mohammad Ali Rai, M.B.,B.S., D.Phil.
Staff Clinician