Kathryn E. Stephenson, M.D., M.P.H.

Kathryn E. Stephenson, M.D., M.P.H.

Principal Investigator and CTU Principal Investigator
Stephenson Laboratory

Associate Professor of Medicine- Harvard Medical School; Ragon Institute of MGH, MIT, and Harvard

Director, Clinical Trials Unit, Center for Virology and Vaccine Research- Beth Israel Deaconess Medical Center

kstephen@bidmc.harvard.edu
T: 617-735-4556
F: 617-735-4566

Dr. Stephenson is a physician-scientist in the Center for Virology and Vaccine Research (CVVR) and the Division of Infectious Diseases at Beth Israel Deaconess Medical Center (BIDMC) in Boston, Massachusetts. She is also an Associate Professor of Medicine at Harvard Medical School. She has expertise in conducting phase 1 clinical trials testing novel immunologic interventions for HIV and emerging infectious diseases like SARS-CoV-2 and Zika virus. During the COVID-19 pandemic, she was the site Principal Investigator for the first-in-human trial of the Johnson & Johnson/Janssen Ad26.COV2.S COVID-19 vaccine, as well as for the Phase 3 efficacy trials of remdesivir, Novavax vaccine, and casirivimab and imdevimab monoclonal antibodies. She is currently the protocol co-chair of CoVPN 3006, the largest federally-funded study to test whether the Moderna COVID-19 vaccine can block SARS-CoV-2 transmission. This COVID-19 work complements her previous contributions in testing a mosaic Ad26-based HIV vaccine and broadly neutralizing antibodies for HIV prevention, treatment and remission. In addition, Dr. Stephenson is an outspoken advocate for increasing research equity for Black and Latinx populations in clinical trials, and is committed to ensuring access to promising medicines and vaccines for our most vulnerable communities.

Dr. Stephenson received her medical degree from New York University, and completed her internal medicine training at Columbia NY Presbyterian Hospital, followed by infectious diseases training at Mass General Brigham. She also obtained a Masters in Public Health from Columbia University where she focused on the ethics of clinical trials, isolation and quarantine.

Education

  • Williams College, Williamstown, MA, B.A., 1996 (Anthropology)
  • Joseph L. Mailman School of Public Health, Columbia University, New York, NY, M.P.H., 2001
  • New York University School of Medicine, New York, NY, M.D., 2005

Training

  • Residency, Columbia University Medical Center, 2005-2008 (Internal Medicine)
  • Clinical Fellowship, Massachusetts General Hospital, Brigham and Women’s Hospital, 2008-2009 (Infectious Diseases)
  • Postdoctoral Fellowship, Center for Virology and Vaccine Research, Beth Israel Deaconess Medial Center, 2009-2011 (Immunology)

Appointments

  • 1997-1999, Research Assistant/Associate, HIV/AIDS Division, San Francisco General Hospital, University of California, San Francisco, San Francisco, CA
  • 2000, Intern, Joint United Nations Programme on HIV/AIDS (UNAIDS), Geneva, Switzerland
  • 2007, Jay I. Meltzer Fellow in Medical Ethics, Columbia University, New York
  • 2011-2016, Associate Physician, Division of Infectious Diseases, Brigham and Women’s Hospital, Boston, MA
  • 2011-2015, Instructor in Medicine, Harvard Medical School, Boston, MA
  • 2011-2016, Consulting Staff, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA
  • 2014-present, Staff Physician, Division of Infectious Diseases, BIDMC, Boston, MA
  • 2015- 2023, Assistant Professor of Medicine, Harvard Medical School
  • 2017-present, Associate Member, Ragon Institute of MGH, MIT and Harvard
  • 2023 – present, Associate Professor of Medicine, Harvard Medical School

Honors

  • 1994 Gargoyle Society Alumni Scholarship, Williams College
  • 1995 Ruchman Fellow, Oakley Center for Humanities and Social Sciences, Williams College
  • 1996 Benjamin B. Wainwright 1920 Prize in English, Williams College
  • 2005 Jack and Diana Nelson Award for Scholarship and Professionalism, NYU School of Medicine
  • 2008 13th Annual Joseph N. Muschel Award, Columbia University, New York-Presbyterian Hospital
  • 2011 AIDS Vaccine 2011 Conference Scholarship, Global HIV Vaccine Enterprise
  • 2012 AIDS Vaccine 2012 Conference Scholarship, Global HIV Vaccine Enterprise
  • 2013 Maxwell Finland Award for Research Excellence, Massachusetts Infectious Diseases Society
  • 2014 Center for AIDS Research Scholar Award, Harvard University
  • 2016 103.3 AMP Radio Badass Chick of the Week
  • 2016 The Omololu Falobi Award for Excellence in HIV Prevention Research Community Advocacy, Global HIV Vaccine Enterprise

Publications

  • Parks KR, Moodie Z, Allen MA, Yen C, Furch BD, MacPhee KJ, Ozorowski G, Heptinstall J, Hahn WO, Zheng Z, Lu H, Grant S, Domin E, Duff MO, Seese A, Marini-Macouzet C, Ballweber-Fleming L, Lee WH, Cottrell CA, Liguori A, Georgeson E, Alavi N, Kubitz M, Phelps N, Seaton KE, Cohen KW, Anderson MA, Mondal K, Laufer DS, Kublin JG, Ward AB, Hyrien O, De Rosa SC, Himansu S, Leav B, Reuter C, Tomaras GD, Montefiori D, Walsh SR, Frank I, Sobieszczyk ME, Goepfert PA, Stephenson KE, Baden LR, Van Tieu H, Keefer MC, Clark J, Riddler SA, Schief WR, McElrath MJ. Vaccination with mRNA-encoded membrane-anchored HIV envelope trimers elicited tier 2 neutralizing antibodies in a phase 1 clinical trial. Science Translational Medicine. 2025 Jul 30;17(809):eady6831. doi: 10.1126/scitranslmed.ady6831. [Article]

  • Riddler SA, Moodie Z, Clark J, Yen C, Allen M, Furch BD, Lu H, Grant S, Mondal K, Anderson M, Maenza J, Lemos MP, Woodward Davis AS, Walsh SR, Sobieszczyk ME, Frank I, Goepfert P, Stephenson KE, Baden LR, Tieu HV, Keefer MC, McElrath MJ, Kublin JG, Corey L. High Frequency of Chronic Urticaria Following an Investigational HIV-1 BG505 MD39.3 Trimer mRNA Vaccine in a Phase 1, Randomized, Open-Label Clinical Trial (HVTN 302). Annals to Internal Medicine. 2025 Jul;178(7):963-974. doi: 10.7326/ANNALS-24-02701. [Article]

  • Huang Y, Zhang L, Gelderblom H, Seaton KE, Yates NL, Paez CA, Karuna ST, Andrew P, Gamble T, Robinson ST, Ledgerwood JE, Hyrien O, Walsh SR, Gay CL, Gwira JA, Spiegel HML, Sobieszczyk ME, Mannheimer SB, Edupuganti S, Hurt CB, Stephenson KE, Yu C, Kelley CF, Mahomed S, Siegel M, Yacovone M, Pensiero MN, Donnell D, Cohen MS, Corey L, Gilbert PB, Koup RA, Tomaras GD; VRC 605, HVTN 127/HPTN 087, HVTN 130/HPTN 089, HVTN 136/HPTN 092, and HVTN 140/HPTN 101 study teams. Fixed dosing versus weight-based dosing of HIV-1 prophylactic monoclonal antibodies in adults: a post-hoc, cross-protocol pharmacokinetics modelling study. EBioMedicine. 2025 Jul;117:105804. doi: 10.1016/j.ebiom.2025.105804. Epub 2025 Jun 13. [Article]

  • Stephenson K. E. (2025). Next-Generation Coronavirus Disease 2019 Vaccines: Clinical Data and Future Directions. Infectious disease clinics of North America39(2), 253–274. https://doi.org/10.1016/j.idc.2025.02.003 [Article]

  • Chawana, T. D., Walsh, S. R., Stranix-Chibanda, L., Chirenje, Z. M., Yu, C., Zhang, L., Seaton, K. E., Heptinstall, J., Zhang, L., Paez, C. A., Gamble, T., Karuna, S. T., Andrew, P., Hanscom, B., Sobieszczyk, M. E., Edupuganti, S., Gay, C. L., Mannheimer, S. B., Hurt, C. B., Stephenson, K. E., … HVTN 127/HPTN 087, HVTN 130/HPTN 089 and HVTN 136/HPTN 092 Study Teams (2025). Pharmacokinetic interaction assessment of an HIV broadly neutralizing monoclonal antibody VRC07-523LS: a cross-protocol analysis of three phase 1 trials in people without HIV. BMC immunology26(1), 8. https://doi.org/10.1186/s12865-025-00687-7 [Article]

  • Edupuganti S, Hurt CB, Stephenson KE, Huang Y, Paez CA, Yu C, Yen C, Hanscom B, He Z, Miner MD, Gamble T, Heptinstall J, Seaton KE, Domin E, Lin BC, McKee K, Doria-Rose N, Regenold S, Spiegel H, Anderson M, McClosky N, Zhang L, Piwowar-Manning E, Ackerman ME, Pensiero M, Dye BJ, Landovitz RJ, Mayer K, Siegel M, Sobieszczyk M, Walsh SR, Gama L, Barouch DH, Montefiori DC, Tomaras GD; HVTN 136/HPTN 092 Study Team. Safety, tolerability, pharmacokinetics, and neutralisation activities of the anti-HIV-1 monoclonal antibody PGT121.414.LS administered alone and in combination with VRC07-523LS in adults without HIV in the USA (HVTN 136/HPTN 092): a first-in-human, open-label, randomised controlled phase 1 trial. Lancet HIV. 2025 Jan;12(1):e13-e25. doi: 10.1016/S2352-3018(24)00247-9. Epub 2024 Dec 10. PMID: 39667379; PMCID: PMC11795396. [Article]

  • Banga, J., Brock-Fisher, T., Petros, B. A., Dai, E. Y., Leonelli, A. T., Dobbins, S. T., Messer, K. S., Nathanson, A. B., Capone, A., Littlehale, N., Appiah-Danquah, V., Dim, S., Moreno, G. K., Crowther, M., DeRuff, K. C., MacInnis, B. L., Springer, M., Sabeti, P. C., & Stephenson, K. E. (2024). Severe Acute Respiratory Syndrome Coronavirus 2 Household Transmission During the Omicron Era in Massachusetts: A Prospective, Case-Ascertained Study Using Genomic Epidemiology. Open forum infectious diseases11(11), ofae591. https://doi.org/10.1093/ofid/ofae591 [Article]

  • Vanshylla, K., Tolboom, J., Stephenson, K. E., Feddes-de Boer, K., Verwilligen, A., Rosendahl Huber, S. K., Rutten, L., Schuitemaker, H., Zahn, R. C., Barouch, D. H., & Wegmann, F. (2024). Mosaic HIV-1 vaccine and SHIV challenge strain V2 loop sequence identity and protection in primates. NPJ vaccines9(1), 179. https://doi.org/10.1038/s41541-024-00974-1 [Article]

  • Govindan, R., & Stephenson, K. E. (2024). HIV Vaccine Development at a Crossroads: New B and T Cell Approaches. Vaccines12(9), 1043. https://doi.org/10.3390/vaccines12091043 [Article]

  • Julg B, Walker-Sperling VEK, Wagh K, Aid M, Stephenson KE, Zash R, Liu J, Nkolola JP, Hoyt A, Castro M, Serebryannyy L, Yanosick K, Speidel T, Borducchi EN, Murzda T, Maxfield L, Arduino R, McDermott AB, Gama L, Giorgi EE, Koup RA, Seaman MS, Rolle CP, DeJesus E, Li W, Korber B, Barouch DH. Safety and antiviral effect of a triple combination of HIV-1 broadly neutralizing antibodies: a phase 1/2a trial. Nat Med. 2024 Sep 12. doi: 10.1038/s41591-024-03247-5. Epub ahead of print. PMID: 39266747. [Article]