Clinical Trials Program
Alicia T. Widge, M.D. (She/Her/Hers)
Associate Chief for Clinical Research and Development
Specialty(s): Allergy and Immunology, Pediatrics Provides direct clinical care to patients at NIH Clinical Center
Major Areas of Research
- Phase 1, first-in-human clinical trials for novel vaccines and monoclonal antibodies for infectious diseases with a high public health burden as well as pandemic/biodefense threats and emerging infectious diseases
- Areas of expertise include SARS-CoV-2, influenza, Nipah, HIV, and Ebola
- Leads the VRC’s Pharmacovigilance Program
Alicia Widge M.D. is the Associate Chief for Clinical Research and Development in the VRC’s Clinical Trials Program. In this role, she serves as a Principal Investigator for multiple Phase 1, first-in-human clinical trials, including a COVID-19 mRNA vaccine, universal influenza vaccine candidates with novel adjuvants, a Nipah virus vaccine, and HIV and Ebola monoclonal antibodies. She is responsible for trial development, scientific guidance, industry collaborations, and leading Investigational new Drug (IND) sponsor responsibilities, including pharmacovigilance, monitoring oversight, clinical trials risk assessment, and quality management for the VRC’s Clinical Trials Program. She is also the clinical lead for collaborations with multiple academic and industry partners.
B.A., 2006, Carleton College
M.S., 2011, Harvard School of Public Health
M.D., 2014, George Washington University School of Medicine and Health Sciences
Dr. Alicia Widge, M.D. is board certified in Allergy/Immunology and Pediatrics. She began her education by completing her B.A in Biology at Carleton College in 2006. She received her Master of Science in Health Policy and Management from the Harvard School of Public Health in 2011. Dr. Widge received her medical degree from George Washington University School of Medicine and Health Sciences in 2014 and went on to complete a residency in Pediatrics at the Children’s National Hospital in Washington, DC in 2017. In 2020, she finished her Clinical Fellowship in Allergy and Immunology at NIAID.
VRC 322/DMID 21-0016: A Phase I, Dose Escalation, Open-Label Clinical Trial to Evaluate Safety, Tolerability, and Immunogenicity of a Nipah Virus (NiV) mRNA Vaccine, mRNA-1215, in Healthy Adults: NCT05398796
VRC 321: A Phase I Open-Label Clinical Trial to Evaluate the Dose, Safety, Tolerability and Immunogenicity of an Influenza H1 Stabilized Stem Ferritin Vaccine, VRC-FLUNPF099-00-VP, in Healthy Adults: NCT03814720
VRC 611: A Phase 1, Open Label, Single-Dose Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of CAP256V2LS, a broadly-neutralizing mAb targeting the V1V2 region of the HIV-1 envelope in healthy adults: NCT04408963
VRC 614: A Phase 1, Dose Escalation, Open-Label Clinical Trial With Experimental Controlled Human Malaria Infections (CHMI) to Evaluate Safety and Protective Efficacy of an Anti-Malaria Human Monoclonal Antibody, VRCMALMAB0114-00-AB (L9LS), in Healthy Malaria-Naive Adults: NCT05019729
VRC 323: A Phase I Open-Label Clinical Trial to Evaluate the Dose, Safety, Tolerability and Immunogenicity of an Influenza H10 Stabilized Stem Ferritin Vaccine, VRC-FLUNPF0103-00-VP, in Healthy Adults: NCT04579250
VRC 612: A Phase 1, Dose Escalation, Open-Label Clinical Trial With Experimental Controlled Human Malaria Infections (CHMI) to Evaluate Safety and Protective Efficacy of an Anti-Malaria Human Monoclonal Antibody, VRCMALMAB0100-00-AB (CIS43LS), in Healthy, Malaria-Naive Adults: NCT04206332
VRC 018: A Phase I Dose Escalation, Randomized, Open-Label Clinical Trial to Evaluate Dose, Safety, Tolerability and Immunogenicity of a HIV-1 Vaccine, VRC-HIVRGP096-00-VP, With Alum in Healthy Adults: NCT03783130
VRC 609: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB091-00-AB (N6LS), Administered Intravenously or Subcutaneously With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20) to Healthy Adults: NCT03538626
VRC 603: A Phase 1 Dose-Escalation Study of the Safety of AAV8-VRC07 (VRC-HIVAAV070-00-GT) Recombinant AAV Vector Expressing VRC07 HIV-1 Neutralizing Antibody in Antiretroviral-Treated, HIV-1 Infected Adults With Controlled Viremia: NCT03374202
VRC 608: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-EBOMAB092-00-AB (MAb114), Administered Intravenously to Healthy Adults: NCT03478891
Coates EE, Edupuganti S, Chen GL, Happe M, Strom L, Widge A, Florez MB, Cox JH, Gordon I, Plummer S, Ola A, Yamshchikov G, Andrews C, Curate-Ingram S, Morgan P, Nagar S, Collins MH, Bray A, Nguyen T, Stein J, Case CL, Kaltovich F, Wycuff D, Liang CJ, Carlton K, Vazquez S, Mascola JR, Ledgerwood JE; VRC 313 Study Team. Safety and immunogenicity of a trivalent virus-like particle vaccine against western, eastern, and Venezuelan equine encephalitis viruses: a phase 1, open-label, dose-escalation, randomised clinical trial. Lancet Infect Dis. 2022 May 11:S1473-3099(22)00052-4.
Casazza JP, Cale EM, Narpala S, Yamshchikov GV, Coates EE, Hendel CS, Novik L, Holman LA, Widge AT, Apte P, Gordon I, Gaudinski MR, Conan-Cibotti M, Lin BC, Nason MC, Trofymenko O, Telscher S, Plummer SH, Wycuff D, Adams WC, Pandey JP, McDermott A, Roederer M, Sukienik AN, O'Dell S, Gall JG, Flach B, Terry TL, Choe M, Shi W, Chen X, Kaltovich F, Saunders KO, Stein JA, Doria-Rose NA, Schwartz RM, Balazs AB, Baltimore D, Nabel GJ, Koup RA, Graham BS, Ledgerwood JE, Mascola JR; VRC 603 Study Team. Safety and tolerability of AAV8 delivery of a broadly neutralizing antibody in adults living with HIV: a phase 1, dose-escalation trial. Nat Med. 2022 May;28(5):1022-1030.
Pajon R, Doria-Rose NA, Shen X, Schmidt SD, O'Dell S, McDanal C, Feng W, Tong J, Eaton A, Maglinao M, Tang H, Manning KE, Edara VV, Lai L, Ellis M, Moore KM, Floyd K, Foster SL, Posavad CM, Atmar RL, Lyke KE, Zhou T, Wang L, Zhang Y, Gaudinski MR, Black WP, Gordon I, Guech M, Ledgerwood JE, Misasi JN, Widge A, Sullivan NJ, Roberts PC, Beigel JH, Korber B, Baden LR, El Sahly H, Chalkias S, Zhou H, Feng J, Girard B, Das R, Aunins A, Edwards DK, Suthar MS, Mascola JR, Montefiori DC. SARS-CoV-2 Omicron Variant Neutralization after mRNA-1273 Booster Vaccination. N Engl J Med. 2022 Mar 17;386(11):1088-1091.
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.
Anderson EJ, Rouphael NG, Widge AT, Jackson LA, 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, Corbett KS, Swanson PA 2nd, Padilla M, Neuzil KM, Bennett H, Leav B, Makowski M, Albert J, Cross K, Edara VV, Floyd K, Suthar MS, Martinez DR, Baric R, Buchanan W, Luke CJ, Phadke VK, Rostad CA, Ledgerwood JE, Graham BS, Beigel JH; mRNA-1273 Study Group. Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults. N Engl J Med. 2020 Dec 17;383(25):2427-2438.
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.
NIAID Allergy/Immunology Fellowship Program