GraceL.ChenMDMPH

Infectious Disease • Bethesda, MD

Vice President, Head of Clinical Development, Hillevax

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Office
Vaccine Research Center, NIAID, NIH
Bethesda, MD 20892
Phone+1 301-646-0725
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Education & Training

National Institutes of Health Clinical CenterFellowship, Infectious Disease, 2006 - 2008
Beth Israel Deaconess Medical CenterResidency, Internal Medicine, 2003 - 2005
NYU Grossman School of MedicineInternship, Internal Medicine, 2002 - 2003
George Washington University School of Medicine and Health SciencesClass of 2002

Certifications & Licensure

HI State Medical License 2005 - 2024
DC State Medical License 2015 - 2022
VA State Medical License 2012 - 2014
ME State Medical License Active through 2013
NY State Medical License 2005 - 2012

Clinical Trials

Trial for Safety and Immunogenicity of a Chikungunya Vaccine, VRC-CHKVLP059-00-VP, in Healthy Adults Start of enrollment: 2015 Nov 18
Completed
Phase 2
Phase 1, Open-label, Single Dose Study to Examine Safety, Tolerability, Pharmacokinetics and Virologic Impact of VRC01LS or VRC07-523LS in HIV-infected Viremic Adults Start of enrollment: 2017 Apr 24
Completed
Phase 1
VRC 705: A Zika Virus DNA Vaccine in Healthy Adults and Adolescents Start of enrollment: 2017 Mar 29
Completed
Phase 2
Influenza HA Ferritin Vaccine, Alone or in Prime-Boost Regimens With an Influenza DNA Vaccine in Healthy Adults Start of enrollment: 2017 Oct 25
Completed
Phase 1
Dose, Safety, Tolerability and Immunogenicity of an Influenza H1 Stabilized Stem Ferritin Vaccine in Healthy Adults Start of enrollment: 2019 Apr 01
Completed
Phase 1
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Publications & Presentations

PubMed

Phase 1 trial evaluating safety and pharmacokinetics of HIV-1 broadly neutralizing mAbs 10E8VLS and VRC07-523LS.
Seemal F Awan, Amarendra Pegu, Larisa Strom, Cristina A Carter, Cynthia S Hendel, LaSonji A Holman, Pamela J Costner, Olga Trofymenko, Renunda Dyer, Ingelise J Gordon,...> ;JCI Insight. 2024 Apr 8
Chikungunya virus virus-like particle vaccine is well tolerated and immunogenic in chikungunya seropositive individuals.
James M McCarty, Lisa Bedell, Jason Mendy, Emily E Coates, Grace L Chen, Julie E Ledgerwood, Sarah Royalty Tredo, Kelly L Warfield, Jason S Richardson> ;Vaccine. 2023 Oct 6
Immune memory shapes human polyclonal antibody responses to H2N2 vaccination.
Yuhe R Yang, Julianna Han, Hailee R Perrett, Sara T Richey, Abigail M Jackson, Alesandra J Rodriguez, Rebecca A Gillespie, Sarah O'Connell, Julie E Raab, Lauren Y Comi...> ;Biorxiv. 2023 Aug 24
14 citations
An influenza H1 hemagglutinin stem-only immunogen elicits a broadly cross-reactive B cell response in humans.
Sarah F Andrews, Lauren Y Cominsky, Geoffrey D Shimberg, Rebecca A Gillespie, Jason Gorman, Julie E Raab, Joshua Brand, Adrian Creanga, Suprabhath R Gajjala, Sandeep N...> ;Science Translational Medicine. 2023 Apr 19
12 citations
An influenza hemagglutinin stem nanoparticle vaccine induces cross-group 1 neutralizing antibodies in healthy adults.
Alicia T Widge, Amelia R Hofstetter, Katherine V Houser, Seemal F Awan, Grace L Chen, Maria C Burgos Florez, Nina M Berkowitz, Floreliz Mendoza, Cynthia S Hendel, LaSo...> ;Science Translational Medicine. 2023 Apr 19
13 citations
A prefusion-stabilized RSV F subunit vaccine elicits B cell responses with greater breadth and potency than a postfusion F vaccine.
Lauren A Chang, Emily Phung, Michelle C Crank, Kaitlyn M Morabito, Tonya Villafana, Filip Dubovsky, Judith Falloon, Mark T Esser, Bob C Lin, Grace L Chen, Barney S Gra...> ;Science Translational Medicine. 2022 Dec 21
7 citations
Elicitation of pneumovirus-specific B cell responses by a prefusion-stabilized respiratory syncytial virus F subunit vaccine.
Emily Phung, Lauren A Chang, Maryam Mukhamedova, Lijuan Yang, Deepika Nair, Scott A Rush, Kaitlyn M Morabito, Jason S McLellan, Ursula J Buchholz, John R Mascola, Mich...> ;Science Translational Medicine. 2022 Jun 22
10 citations
Safety and immunogenicity of a trivalent virus-like particle vaccine against western, eastern, and Venezuelan equine encephalitis viruses: a phase 1, open-label, dose-...
Emily E Coates, Srilatha Edupuganti, Grace L Chen, Myra Happe, Larisa Strom, Alicia Widge, Maria Burgos Florez, Josephine H Cox, Ingelise Gordon, Sarah Plummer, Abidem...> ;The Lancet. Infectious Diseases. 2022 Aug 1
55 citations
Safety and immunogenicity of a ferritin nanoparticle H2 influenza vaccine in healthy adults: a phase 1 trial.
Katherine V Houser, Grace L Chen, Cristina Carter, Michelle C Crank, Thuy A Nguyen, Maria Claudia Burgos Florez, Nina M Berkowitz, Floreliz Mendoza, Cynthia Starr Hend...> ;Nature Medicine. 2022 Feb 1
11 citations
A single residue in influenza virus H2 hemagglutinin enhances the breadth of the B cell response elicited by H2 vaccination.
Sarah F Andrews, Julie E Raab, Jason Gorman, Rebecca A Gillespie, Crystal S F Cheung, Reda Rawi, Lauren Y Cominsky, Jeffrey C Boyington, Adrian Creanga, Chen-Hsiang Sh...> ;Nature Medicine. 2022 Feb 1
31 citations
Safety, tolerability, and immunogenicity of the respiratory syncytial virus prefusion F subunit vaccine DS-Cav1: a phase 1, randomised, open-label, dose-escalation cli...
Tracy J. Ruckwardt, Kaitlyn M. Morabito, Emily Phung, Michelle C. Crank, Pamela Costner, LaSonji A. Holman, Lauren A. Chang, Somia P. Hickman, Nina M. Berkowitz, Ingel...> ;The Lancet. Respiratory Medicine. 2021 Oct 1
5 citations
Limited Flavivirus Cross-Reactive Antibody Responses Elicited by a Zika Virus Deoxyribonucleic Acid Vaccine Candidate in Humans.
Katherine E. Burgomaster, Bryant M. Foreman, Maya Aleshnick, Bridget C. Larman, David N. Gordon, Sonia Maciejewski, Kaitlyn M. Morabito, Julie E. Ledgerwood, Martin R....> ;The Journal of Infectious Diseases. 2021 May 7
25 citations
Vaccination with prefusion-stabilized respiratory syncytial virus fusion protein induces genetically and antigenically diverse antibody responses.
Maryam Mukhamedova, Daniel Wrapp, Chen-Hsiang Shen, Morgan S.A. Gilman, Tracy J. Ruckwardt, Chaim A. Schramm, Larissa Ault, Lauren A. Chang, Alexandrine Derrien-Colemy...> ;Immunity. 2021 Apr 13
Chikungunya Virus-Like Particle Vaccine-Reply.
Grace L. Chen> ;JAMA. 2020 Sep 8
54 citations
Effect of a Chikungunya Virus-Like Particle Vaccine on Safety and Tolerability Outcomes: A Randomized Clinical Trial.
Grace L. Chen, Emily E. Coates, Sarah H. Plummer, Cristina Carter, Nina M. Berkowitz, Michelle Conan-Cibotti, Josephine H. Cox, Allison Beck, Mark O’Callahan, Charla A...> ;JAMA. 2020 Apr 14
53 citations
Safety and pharmacokinetics of broadly neutralising human monoclonal antibody VRC07-523LS in healthy adults: a phase 1 dose-escalation clinical trial
Martin R. Gaudinski, Katherine V. Houser, Nicole A. Doria-Rose, Grace L. Chen, Ro Shauna S Rothwell, Nina M. Berkowitz, Pamela Costner, LaSonji A. Holman, Ingelise J. ...> ;The Lancet. HIV. 2019 Oct 1
15 citations
Safety and immunogenicity of investigational seasonal influenza hemagglutinin DNA vaccine followed by trivalent inactivated vaccine administered intradermally or intra...
Cristina Carter, Katherine V. Houser, Galina Yamshchikov, Abbie R. Bellamy, Jeanine May, Mary E. Enama, Uzma N. Sarwar, Brenda Larkin, Robert T. Bailer, Richard A. Kou...> ;Plos One. 2019 Sep 18
84 citations
Activation Dynamics and Immunoglobulin Evolution of Pre-existing and Newly Generated Human Memory B cell Responses to Influenza Hemagglutinin
Sarah F. Andrews, Michael Chambers, Chaim A. Schramm, Jason Plyler, Julie E. Raab, Masaru Kanekiyo, Rebecca A. Gillespie, Amy Ransier, Sam Darko, Jianfei Hu, Xuejun Ch...> ;Immunity. 2019 Aug 20
183 citations
A proof of concept for structure-based vaccine design targeting RSV in humans.
Michelle C. Crank, Tracy J. Ruckwardt, Man Chen, Kaitlyn M. Morabito, Emily Phung, Pamela Costner, LaSonji A. Holman, Somia P. Hickman, Nina M. Berkowitz, Ingelise J. ...> ;Science. 2019 Aug 2
22 citations
Epitope-Specific Serological Assays for RSV: Conformation Matters.
Emily Phung, Lauren A. Chang, Kaitlyn M. Morabito, Masaru Kanekiyo, Man Chen, Deepika Nair, Azad Kumar, Grace L. Chen, Julie E. Ledgerwood, Barney S. Graham, Tracy J. ...> ;Vaccines. 2019 Feb 23
72 citations
Safety, tolerability, pharmacokinetics, and immunogenicity of the therapeutic monoclonal antibody mAb114 targeting Ebola virus glycoprotein (VRC 608): an open-label ph...
Martin R. Gaudinski, Emily E. Coates, Laura Novik, Alicia T. Widge, Katherine V. Houser, Eugeania Burch, LaSonji A. Holman, Ingelise J. Gordon, Grace L. Chen, Cristina...> ;Lancet. 2019 Mar 2
141 citations
Safety and pharmacokinetics of the Fc-modified HIV-1 human monoclonal antibody VRC01LS: A Phase 1 open-label clinical trial in healthy adults.
Martin R. Gaudinski, Emily E. Coates, Katherine V. Houser, Grace L. Chen, Galina Yamshchikov, Jamie G. Saunders, LaSonji A. Holman, Ingelise J. Gordon, Sarah H. Plumme...> ;Plos Medicine. 2018 Jan 24
194 citations
Safety, tolerability, and immunogenicity of two Zika virus DNA vaccine candidates in healthy adults: randomised, open-label, phase 1 clinical trials
Martin R. Gaudinski, Katherine V. Houser, Kaitlyn M. Morabito, Zonghui Hu, Galina Yamshchikov, Ro Shauna S Rothwell, Nina M. Berkowitz, Floreliz Mendoza, Jamie G. Saun...> ;Lancet. 2017 Dec 5
37 citations
Identifying Gaps in Respiratory Syncytial Virus Disease Epidemiology in the United States Prior to the Introduction of Vaccines
Lindsay Kim, Brian Rha, Jon S. Abramson, Larry J. Anderson, Carrie L. Byington, Grace L. Chen, John P. DeVincenzo, Kathryn M. Edwards, Janet A. Englund, Ann R. Falsey,...> ;Clinical Infectious Diseases. 2017 Sep 15
10 citations
Association between shunt-responsive idiopathic normal pressure hydrocephalus and alcohol
Thu-Trang T. Hickman, Matthew E. Shuman, Tatyana A. Johnson, Felix Yang, Rebecca R. Rice, Isaac M. Rice, Esther H. Chung, Robert Wiemann, Megan Tinl, Christine Irachet...> ;Journal of Neurosurgery. 2017 Aug 1
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