Laboratory for HIV and COVID-19 Vaccine Research and Development

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. He has published over 850 original research papers that have helped shape the scientific rationale for antibody-based vaccines.

Dr. Montefiori also directs large vaccine immune monitoring programs funded by the NIH and the 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. 

Key Projects Underway

• Ongoing characterization of the neutralization complexities of circulating strains 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
• Defining the requirements for HIV 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 broadly neutralizing monoclonal antibodies.
• Identification and characterization of novel HIV-1 neutralization epitopes.
• 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 Core

• Kelli Greene, MPH, PMP, Director of Scientific Program Management
• Hongmei Gao, MD, MBA, PMP, Director of Scientific Program Management
• Amanda Eaton, MBA, Scientific Program Management
• Elize Domin, BS, Research Project Management

Laboratory Cores

• Jin Tong, BS, Operations & Safety Manager
• Nolan Yeung, MS, GCLP Manager
• Juanfei (Peter) Gao, MS, Specimen & Database Manager
• Haili Tang, MS, Senior Research Analyst
• Wenhong Feng, MD, Research Analyst II
• Xiaoju (Lily) Daniell, PhD, Research Analyst II
• Leihua Liu, MD, Research Analyst II
• Jiayu Chen, MD, Research Analyst I
• Stephanie Martin, MS, Research Analyst I
• Jessica McLanahan, MS, Research Analyst I
• Mariia (Sasha) Boiko, MD, Research Technician III
• Kirill Milov, BS, Research Technician III
• Eve Melbouci, BS, Research Technician III
• Cole Niedmann, BS, Research Technician III
• McKenzie Frazier, BS, Research Technician III

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: 919-681-7771
Email: hongmei.gao@duke.edu