Duke Human Vaccine Institute

What Duke Human Vaccine Institute does

The Duke Human Vaccine Institute (DHVI) is an academic research institute within Duke University School of Medicine, founded in 1990 by Barton Haynes, MD, that develops vaccines, therapeutics, and diagnostics for infectious diseases of global health importance including HIV/AIDS, influenza, SARS-CoV-2, tuberculosis, syphilis, and gonorrhea. The institute operates across basic discovery and translational work, running a Regional Biocontainment Laboratory, an Immunology Virology Quality Assessment Center (IVQAC), a Clinical Trials Unit, and an Accessioning Unit and Biorepository. Its HIV vaccine research program has spanned more than 35 years and has produced broadly neutralizing antibody candidates now in clinical testing, and its COVID-19 response yielded more than 2,500 isolated antibodies within ten weeks of program launch.

DHVI's technical stack combines structural biology (cryo-electron microscopy on a Titan Krios system, x-ray crystallography) with computational biology and bioinformatics, supported by on-site Good Manufacturing Practice (cGMP) facilities capable of producing HIV antigens, mRNA therapies and vaccines, and cell or bacterial-based products for early phase clinical trials. Core platforms include a 15-year-developed antibody isolation and characterization platform, mRNA manufacturing for antibody and vaccine candidates, and a pan-coronavirus vaccine design effort intended to protect against SARS-CoV-2, SARS-CoV-1, MERS, and related bat coronaviruses. The institute holds CAP, CLIA, ISO 17043, ISO 20387:2018, and GCLP accreditations and operates the global External Quality Assurance Program Oversight Laboratory (EQAPOL) with 91 sites across 19 countries; its biorepository is among only ten A2LA ISO 20387-accredited biobanks worldwide.

DHVI does not sell commercial products and has no disclosed pricing model. Its revenue model is grant-funded: the institute is primarily funded by multi-year contracts and grants from the National Institute of Allergy and Infectious Diseases (NIAID), DARPA, the National Institutes of Health, the Centers for Disease Control and Prevention, and supplemental appropriations from the North Carolina legislature. Significant historical awards include a 2005 $300 million federal AIDS vaccine grant, a 2017 seven-year $41.5 million NIAID quality assurance contract renewal, a 2019 NIAID flu vaccine program with first-year funding of approximately $29.6 million and a seven-year ceiling of up to $400 million, and a 2021 seven-year $16.2 million NIAID Immunology Quality Assessment contract representing 28 consecutive years of continuous funding. Customers are federal health agencies, clinical trial networks (AIDS Clinical Trials Group, HIV Vaccine Trials Network, HIV Prevention Trials Network, Microbicide Trials Network), and global research laboratories participating in DHVI's quality assurance programs.

Name

Duke Human Vaccine Institute

Legal name

Duke Human Vaccine Institute

Website

https://dhvi.duke.edu

Company type

Private

Founded year

1990

Operating status

Operating

Headcount range

101–250 employees

Short description

DHVI is a Duke University research institute developing vaccines, therapeutics, and diagnostics for HIV, influenza, SARS-CoV-2, tuberculosis, and gonorrhea using cGMP manufacturing, cryo-EM, and global quality assessment programs funded by federal grants.

Ownership category

akta.pro rank

Product category

Vaccine Research and Development

NAICS

Research and Development in the Physical, Engineering, and Life Sciences (54171), Scientific Research and Development Services (5417), Medical Laboratories (621511), Medical and Diagnostic Laboratories (62151), Testing Laboratories and Services (54138)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Medical Laboratories (8071), Pharmaceutical Preparations (2834)

akta.pro primary industry

Pandemic Preparedness & Rapid-Response Vaccines (HLAIAEAF)

akta.pro secondary industries

Global Health Research, Clinical Trials & Product Development Partnerships (PDPs) (HLAJAOAM), Infectious Disease & Pandemic Preparedness Vaccines (emerging pathogens) (HLAAAEAC), National Public Health Reference Laboratories (HLAJAIAA), Microbiology & Infectious Disease Diagnostics (culture, rapid antigen, syndromic panels) (HLAAALAC), Infectious Disease POCT (Respiratory, STI, HIV, Sepsis) (HLAHAOAA)

Keywords

• Vaccine research services
• Infectious disease therapeutics
• Clinical trial management
• Quality assessment programs
• Biopharmaceutical manufacturing

Headquarters

HQ city

Durham

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Operations, Infrastructure

Marketing channels4 records

Core offering

DHVI is an academic research institute that develops novel vaccines, therapeutics, and diagnostics for infectious diseases of global health importance, including HIV/AIDS, influenza, SARS-CoV-2, tuberculosis, syphilis, and gonorrhea. It conducts basic and translational research from antigen discovery through cGMP manufacturing of clinical trial materials, and operates quality assurance programs (EQAPOL, IQA, VQA) supporting laboratories worldwide.

Product overview

Duke Human Vaccine Institute operates as an integrated research institute offering a comprehensive suite of vaccine development services. The portfolio centers on vaccine R&D spanning basic science through clinical trials, supported by cGMP manufacturing capabilities, quality assessment programs (IVQAC including EQAPOL, IQA, VQA, NHPCVL), clinical trial infrastructure (Duke Vaccine and Trials Unit), biobanking services (Accessioning Unit and Biorepository), and biosafety training (Regional Biocontainment Laboratory, DIDRT). Research focuses on HIV/AIDS, influenza, SARS-CoV-2, tuberculosis, and other infectious diseases, with capabilities for mRNA vaccine production and pan-coronavirus vaccine development.

Differentiator

Problem solved

Functional benefit

Products and services

• Vaccine Research and Development Services Comprehensive vaccine research and development encompassing basic science, translational research, and clinical trials for infectious diseases including HIV/AIDS, influenza, SARS-CoV-2, tuberculosis, syphilis, and gonorrhea.
• cGMP Manufacturing Services Good Manufacturing Practice facilities producing HIV antigens, mRNA therapies and vaccines, and cell or bacterial-based products for early phase clinical trials.
• Immunology Virology Quality Assessment Center (IVQAC) Services Comprehensive quality assurance center providing External Quality Assurance Oversight Laboratory (EQAPOL), Immunology Quality Assessment (IQA), Virology Quality Assurance Program (VQA), and Non-Human Primate Core Virology Laboratory (NHPCVL) services for domestic and international laboratories.
• Duke Vaccine and Trials Unit Clinical trial infrastructure for Phase 1/2/3 vaccine trials, including human challenge studies and enrollment of volunteers for vaccine candidate testing.
• DHVI Biorepository and Accessioning Unit ISO 20387 accredited biobanking services with cryopreserved peripheral blood mononuclear cells (PBMCs) serving clinical trials and research programs.
• Duke Regional Biocontainment Laboratory (RBL) High-containment research facility for training and performing research on infectious disease agents, supporting pandemic preparedness efforts.
• Duke Infectious Disease Response Training (DIDRT) Biosafety and infectious disease response training program delivered through a five-state consortium funded by NIEHS.

Quantifiable outcome

• Isolated 2,500+ antibodies from COVID-19 individuals in 10 weeks
• +3 more outcomes

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

23 partnerships are on record, tiered core, major and minor.

• Butantan InstitutecoreStrategic or Co-development Partner · 29 August 2024Partnership between Duke Human Vaccine Institute and Butantan (Brazilian vaccine institute) for collaborative vaccine research and development. Agreement signed August 29, 2024.
• Blood Systems Research InstitutecoreStrategic or Co-development PartnerCollaboration on HIV Viral Diversity Program - partners providing source material for viral isolate collection representing global genetic and geographic diversity.
• International AIDS Vaccine Initiative (IAVI)coreStrategic or Co-development PartnerCollaboration on HIV vaccine research including Protocol C investigators and vaccine development efforts.
• HIV Vaccine Trial Network (HVTN)coreStrategic or Co-development PartnerCollaboration for HIV vaccine clinical trials and research coordination.
• US Military HIV Research Program (MHRP)coreStrategic or Co-development PartnerCollaboration on HIV research with military HIV research program.
• Harvard UniversitymajorStrategic or Co-development PartnerCollaboration with Harvard researchers including Vladimir Novitsky on HIV viral diversity studies.
• University of PennsylvaniamajorStrategic or Co-development PartnerCollaboration with George Shaw and Beatrice Hahn from UPenn on HIV research.
• South African National Blood ServicemajorStrategic or Co-development PartnerCollaboration on viral diversity panel development with South African blood service.
• Vitalant Research InstitutecoreStrategic or Co-development PartnerPartnership with Michael Busch at Vitalant Research Institute for HIV research and viral diversity program.
• Boston Children's HospitalmajorStrategic or Co-development PartnerCollaborative work on CIVICs influenza vaccine development - basic immunology and virology research.
• Ragon Institute of MGH, MIT and HarvardmajorStrategic or Co-development PartnerCollaboration on influenza vaccine development research.
• University of PennsylvaniamajorStrategic or Co-development PartnerCollaboration on influenza vaccine candidate development.
• University of TexasmajorStrategic or Co-development PartnerCollaboration on influenza vaccine development.
• University of IowamajorStrategic or Co-development PartnerCollaboration on clinical trials for influenza vaccines under CIVICs program.
• Imperial College LondonmajorStrategic or Co-development PartnerInternational collaboration on clinical trials for influenza vaccines.
• UNC-Chapel HillmajorStrategic or Co-development PartnerCollaboration on pan-coronavirus vaccine development.
• Oregon Health & Science University (OHSU)majorStrategic or Co-development PartnerPhase 1 clinical trial partnership for HydroVax yellow fever vaccine - Duke leading clinical trial, OHSU studying immune response.
• Najít Technologies, Inc.majorStrategic or Co-development PartnerLicensing partner for HydroVax vaccine platform - OHSU spinoff developing hydrogen peroxide-based vaccine technology.
• Centers for Disease Control and Prevention (CDC)coreStrategic or Co-development PartnerCollaboration on Limiting Antigen (LAg) Avidity Incidence Assay EQA program for HIV incidence estimation.
• University of ChicagominorImplementation/ SI/ Consulting PartnerPartner in DIDRT Consortium for infectious disease response training - one of four high-containment facilities in network.
• George Mason UniversityminorImplementation/ SI/ Consulting PartnerPartner in DIDRT Consortium for infectious disease response training.
• University of LouisvilleminorImplementation/ SI/ Consulting PartnerPartner in DIDRT Consortium for infectious disease response training.
• Colorado State UniversityminorImplementation/ SI/ Consulting PartnerPartner in DIDRT Consortium for infectious disease response training.

Scale indicators14 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• La Jolla Institute for Immunology: Non-profit research institute focused on immunology and infectious disease, with parallel programs in vaccine development, immune monitoring, and structural biology. Directly comparable as an academic-affiliated vaccine R&D center with similar funding model and disease focus.
• Wistar Institute: Non-profit biomedical research institute with a Vaccine & Immunotherapy Center focused on infectious diseases and cancer immunotherapies. Comparable as a similarly-sized academic-affiliated vaccine R&D institute with grant-based funding.
• Emory Vaccine Center: University-based vaccine research center at Emory focused on HIV, influenza, and emerging pathogens. Direct academic peer with overlapping NIAID funding sources and HIV clinical trial network involvement.
• Ragon Institute of MGH, MIT and Harvard: Cross-institutional immunology institute focused on HIV vaccine development and infectious disease. DHVI is an explicit collaboration partner with Ragon on influenza vaccine development under the CIVICs program.
• Baylor College of Medicine - Texas Children's Hospital Center for Vaccine Development: Academic vaccine development center with strong tropical disease and pediatric vaccine focus, including cGMP manufacturing. Comparable translational pipeline and global health orientation.

Broad incumbents

• NIAID Vaccine Research Center (VRC): The federal government's flagship vaccine R&D center within NIH. Shares HIV, influenza, and emerging pathogen focus with DHVI, but operates with direct federal appropriations rather than grant capture, and at larger scale.
• Scripps Research Institute: Major non-profit biomedical research organization with structural biology, immunology, and infectious disease programs. Comparable in scale, academic affiliation, and disease focus, including HIV/AIDS vaccine research.
• Fred Hutchinson Cancer Center: Major non-profit research center with deep HIV vaccine and immunotherapy programs, including leadership of the HIV Vaccine Trials Network. Comparable in scale and NIAID funding footprint, though broader in cancer scope.

Emerging players

• International AIDS Vaccine Initiative (IAVI): Global non-profit PDP focused exclusively on HIV vaccine development. DHVI is a formal research partner with IAVI on Protocol C and HIV vaccine development. Comparable mission and global health partnership model.

Regional players

• Butantan Institute: Brazilian state-run vaccine manufacturer and research institute. DHVI signed a strategic co-development partnership with Butantan in August 2024. Comparable integrated vaccine R&D and manufacturing model, but regionally focused on Latin America.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/the-duke-human-vaccine-institute
• Xx.com/TheDHVI
• Facebookfacebook.com/TheDHVI

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles16 records

Funding overview

Funding rounds2 records

Investors1 record

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M&A

Investments

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Frequently asked questions about Duke Human Vaccine Institute