Dr. Montefiori is a Professor and Director of the Laboratory for HIV and COVID-19 Vaccine Research & Development in the Department of Surgery, Division of Surgical Sciences at Duke University Medical Center. His major research interests are viral immunology and HIV and COVID-19 vaccine development, with a special emphasis on neutralizing antibodies. Multiple aspects of HIV-1 neutralizing antibodies are studied in his laboratory, including mechanisms of neutralization and escape, epitope diversity among the different genetic subtypes and geographic distributions of the virus, neutralizing epitopes, requirements to elicit protective neutralizing antibodies by vaccination, optimal combinations of neutralizing antibodies for immunoprophylaxis, and novel vaccine designs for HIV-1.

Dr. Montefiori also directs large vaccine immune monitoring programs funded by the NIH and the Bill & Melinda Gates Foundation that operate in compliance with Good Clinical Laboratory Practices and have served as a national and international resource for standardized assessments of neutralizing antibody responses in preclinical and clinical trials of candidate HIV vaccines since 1988. At the onset of the COVID-19 pandemic, he turned his attention to SARS-CoV-2, with a special interest in emerging variants and how they might impact transmission, vaccines, and immunotherapeutics. His rapid response to emerging SARS-CoV-2 variants of concern provided some of the earliest evidence of the potential risk the variants pose to vaccines.

In May 2020, his laboratory was recruited by the US Government to lead the national neutralizing antibody laboratory program for COVID-19 vaccines. His laboratory utilizes FDA-approved validated assay criteria to facilitate regulatory approvals of COVID-19 vaccines. He has published over 750 original research papers that have helped shape the scientific rationale for antibody-based vaccines.

Key Projects Underway

• Ongoing characterization of global neutralization serotypes of HIV-1
• Preclinical and clinical evaluation of passively delivered broadly neutralizing antibodies for HIV-1 prevention and treatment
• Immunologic correlates of protection against the acquisition of HIV infection
• Structural and immunologic requirements for broadly neutralizing antibody induction
• Novel HIV-1 vaccine designs
• Ongoing characterization of neutralization escape by emerging SARS-CoV-2 variants
• Preclinical and clinical evaluation of neutralizing antibodies in COVID-19 vaccine studies

Selected Achievements

• First demonstration of neutralizing antibodies as a correlate of protection against HIV-1 infection in humans.
• Identification of a threshold titer of neutralizing antibodies required for HIV-1 prevention.
• Demonstration of mRNA vaccine-elicited neutralizing antibodies as a correlate of protection against COVID-19.
• Established “gold standard” reference strains and validated assays for highly standardized assessments of HIV-1 vaccine-elicited neutralizing antibodies.
• Tiered categorization of HIV-1 neutralization phenotypes.
• Detailed analyses of the magnitude, breadth, and complementarity of HIV-1 neutralizing antibodies.
• Identification of novel HIV-1 neutralization epitopes.
• First report of the initial HIV-1 autologous neutralizing antibody response targeting a broadly neutralizing epitope.
• Identification of HIV-1 genetic signatures of neutralization. Translation of this information to vaccine design.
• Role of Fc gamma receptors in potentiating antibody-mediated HIV-1 neutralization.
• Demonstration of genetic drift and clade preferences in HIV-1 neutralization epitopes.

Advanced Training

Basic and applied research projects focusing on HIV-1 vaccine development 

Laboratory Management & Planning

• Hongmei Gao, Director of Scientific Program Management
• Kelli Greene, Director of Scientific Program Management
• Miroslawa Bilska, Scientific Research Laboratory Manager
• Amanda Eaton, Scientific Program Leader II
• Elize Domin, Research Project Manager
• Francesca Suman, Research Project Manager
• Barbara Mitchell, Business Manager
• Nolan Yeung, GCLP & Operations Manager

Laboratory Cores

• Haili Tang, Senior Research Analyst
• Charlene McDanal, Senior Research Analyst
• Wenhong Feng, Research Analyst II
• Leihua Liu, Research Analyst II
• Xiaoju (Lily) Daniell, Research Analyst II
• Jin Tong, Research Analyst II
• Jiayu Chen, Research Analyst I
• Alice Kimbell, Research Analyst I
• Sarah Hiles, Research Analyst II
• Qi Qi, Research Technician Senior
• Andrea Pham, Research Technician III
• Stephanie Martin, Research Analyst I
• Kirill Milov, Research Technician II
• Jessica Zdunksi, Research Technician III
• Shelby Flaherty, Research Technician III
• Meilang Flowers, Research Analyst II
• Juanfei (Peter) Gao, Specimen & Database Manager

David C. Montefiori, PhD
Laboratory Director
Phone: 919-684-5278
Email: monte@duke.edu

Shaunna Shen, DVM, PhD
Laboratory Deputy Director
Phone: 919-684-9986
Email: sxshen@duke.edu

Kelli Greene, MPH, PMP
Director of Scientific Program Management
Phone: 919-681-7771
Email: kelli.greene@duke.edu

Hongmei Gao, MD, MBA, PMP 
Director of Scientific Program Management
Phone: 919-681-7776
Email: hongmei.gao@duke.edu