IVI and the United States

U.S. Leadership at IVI

IVI Senior Leadership

Dr. Julia Lynch, Director of Cholera Program

Board of Trustees

Dr. Deborah Birx (Chair of Compensation & Benefits Committee), Chief Executive Officer, Armata Pharmaceuticals

Ms. Yanchun Lily Li, Founder and Chief Executive Officer, Harvard Wealth Strategy and Management LLC.

Mr. Richard Henriques (Treasurer & Chair of Finance and Audit Committee), Senior Fellow, Center for High Impact Philanthropy, University of Pennsylvania.

Dr. Srishti Gupta, Chief Executive Officer, Novabridge Biosciences

Dr. Seth Berkley, Senior Adviser & Adjunct Professor, School of Public Health, Brown University

Dr. Nanette Cocero, Former Global President, Vaccines, Pfizer, Inc.

Scientific Advisory Group

Dr. Susan Barnett, (Vice Chairperson), Senior Program Officer, HIV Vaccine Product and Clinical Development, Global Health, Gates Foundation

Dr. George R. Siber, President, Siber Biotechnologies

Dr. Sandhya Vasan, Senior Vice President, Global Infectious Diseases Research, Henry H. Jackson Foundation for the Advancement of Military Medicine

Global Advisory Group of Experts

Dr. Mark Dybul, Executive Chairman, Purpose Life Sciences

Ongoing Collaboration

Broadly Protective SARS-CoV‐2 VLP-forming mRNA Vaccine (BPCOV2)

The BPCOV2 project, conducted in collaboration with the University of Pennsylvania, the University of North Carolina, and the University of California, Davis, aims to develop a broadly protective, virus-like particle–forming mRNA vaccine targeting SARS-CoV-2 variants and zoonotic sarbecoviruses, with the long-term goal of contributing to a universal pan-sarbecovirus vaccine platform. The project focuses on designing and optimizing mRNA-LNP constructs encoding multiple spike proteins that self-assemble into multivalent virus-like particles in vivo, inducing strong neutralizing antibodies, Fc-mediated effector functions, and robust T-cell immunity. The project seeks to achieve broad cross-protection and generate a scalable platform for pandemic preparedness.

Capturing Data on Antimicrobial Resistance Patterns and Trends in Use in Regions of Asia (CAPTURA)

The CAPTURA project focuses on strengthening the quality, analysis, and use of AMR surveillance data in the human health sector across countries in South and Southeast Asia. Phase II uses improved approaches to monitor surveillance sites and system performance, enhance surveillance data management, and inform strategic planning to sustainably strengthen AMR surveillance systems. IVI leads the project in collaboration with several partners, including the Brigham and Women’s Hospital.

Cholera Vaccine Program

The International Vaccine Institute’s Cholera Program focuses on accelerating the development and introduction of safe, effective, and affordable oral cholera vaccines (OCVs) to combat epidemic and endemic cholera in low- and middle-income countries. The program is run in collaboration with U.S. partners, such as John Hopkins University, Massachusetts General Hospital, and the University of Maryland, and is funded by the Gates Foundation.

Full Value of Vaccine Assessment for invasive non-typhoidal Salmonella vaccines

IVI, in collaboration with New York University, is conducting a Full Value of Vaccine Assessment for invasive non-typhoidal Salmonella to inform global decision-making on vaccine development and use. The assessment examines public health impact, regulatory pathways, and economic considerations to guide investment and policy discussions.

Hepatitis E Vaccine Roadmap

IVI and its partners are contributing to a roadmap to identify the key remaining barriers to wider availability and use of the Hepatitis E vaccine Hecolin®. IVI’s Hepatitis E Program includes clinical trials in Pakistan and South Africa of the Hecolin® vaccine to bridge key knowledge gaps by generating evidence on the safety and immunogenicity of the hepatitis E vaccine across a wider age range and in vulnerable populations. As part of this project, IVI is identifying and prioritizing clinical evidence gaps to inform policy and meet requirements (WHO and country-level) for routine and emergency use, while also assessing the timeline expected for WHO prequalification of Hecolin® and the status of other manufacturers with HEV vaccines in their development pipelines. This work is done in collaboration with U.S. institutions such as Johns Hopkins University and Syracuse University, alongside funding from the Gates Foundation and Coefficient Giving.

Phase II Trial of the Cholera Conjugate Vaccine in Kenya

Conjugate vaccines, a new generation of vaccines, elicit a durable T-cell-dependent immune response in young children, often with just a single dose. An injectable cholera conjugate vaccine offering long-lasting protection could be cost-effectively integrated into the Expanded Programme on Immunization, a global health initiative, thereby reducing the need for repeated vaccination campaigns while building population immunity from infancy onward. Following the vaccine’s initial development and a phase I trial in 2024, IVI is preparing to launch a phase II clinical trial in Nairobi, Kenya. In 2025, IVI, with partners like TransPerfect and funding from Coefficient Giving, finalized clinical site selection and protocol development, received regulatory approvals from the Kenyan government, and organized a workshop.

Systems Serology Platform Technology

With funding from the Gates Foundation and in collaboration with Harvard University and Massachusetts General Hospital, IVI aims to develop and apply a systems serology platform to identify immune correlates of protection and novel serological biomarkers for infectious diseases.

In 2022, IVI began work on a systems serology platform technology to facilitate the discovery of novel biomarkers for infectious diseases. This technology helps identify immune correlates of protection and distinct biomarkers in typhoid, invasive non-typhoidal Salmonella, and COVID-19 using animal and human clinical samples.

In 2024, IVI established key assays for systems serology and began assessing samples obtained from clinical studies of typhoid conjugate vaccines, COVID-19 vaccines, and the oral cholera vaccine Euvichol®-S to investigate distinct immunological biomarkers. Manuscripts on serological profiling for AdCLD-CoV19 and typhoid conjugate vaccines are in progress.

Shigella Vaccine Development

IVI’s Shigella vaccine development program is a follow-up to IVI’s 2001-2005 DOMI Shigella Program. Since 2020, IVI has optimized and analyzed STM technology with the intent to transfer the technology to PATH and test its efficacy with the University of Georgia and the Walter Reed Army Institute of Research.

In 2023, IVI joined a consortium with Massachusetts General Hospital, Harvard University, and Tulane University to jointly develop a quadrivalent Shigella conjugate vaccine targeting Shigella flexneri 2a, 3a, 6, and S. sonnei. The consortium aims to develop the manufacturing process to produce a vaccine and support eventual technology transfer to a manufacturer. In 2024, IVI began cell bank preparation and the establishment of process development and manufacturing techniques with funding from the U.S. National Institutes of Health.

Strep A Vaccine Global Consortium 2.0

The Strep A Vaccine Global Consortium (SAVAC) 2.0 aims to accelerate Strep A vaccine development through three integrated, cross-disciplinary workstreams focused on preparing for vaccine trials, engaging industry, and mobilizing non-industry stakeholders. Within that framework, SAVAC 2.0 also seeks to identify and address barriers to investment in Strep A vaccine research and development. The project has received funding from the Leducq Foundation and Coefficient Giving and is being implemented in collaboration with the Harvard T.H. Chan School of Public Health.

Vaccine Against Schistosomiasis for Africa (VASA)

Supported by the Gates Foundation, VASA brings together research institutions from around the world, including PAI Life Sciences Inc. and Texas Tech University Health Sciences Center, to advance the development of SchistoShield®, one of the world’s most promising vaccine candidates. The project is helping move the vaccine through clinical development while generating the evidence needed to support its future use in endemic settings.

Previous Collaboration

Vaccine Impact Modeling for Typhoid and Cholera

IVI conducted a project in collaboration with Johns Hopkins University and Yale University. It consisted of vaccine impact modeling for typhoid fever and cholera, supporting public health strategies by generating insights into disease dynamics, epidemiological trends, and the potential benefits of vaccination. These models integrated epidemiological data, vaccine characteristics, and population demographics to estimate disease burden and project vaccination impacts under various scenarios. By quantifying public health and economic benefits, the modeling informed policy decisions, guided resource allocation, and strengthened the design and implementation of vaccination programs.

COCOA: COVID Vaccine Clinical and Operational Alliance

IVI collaborated with SK bioscience, with funding from the Coalition for Epidemic Preparedness Innovations (CEPI), to advance the development and evaluation of a recombinant protein nanoparticle COVID-19 vaccine candidate. The partnership focused on conducting large-scale phase III clinical studies to assess the vaccine’s safety, tolerability, and ability to stimulate immune responses when administered as a booster dose in adults.

The studies evaluated both homologous and heterologous booster vaccination strategies and were successfully completed across multiple countries and research sites. The project brought together a consortium of leading organizations, including SK bioscience, IVI, the Institute for Protein Design at the University of Washington, and the Gates Foundation, contributing expertise in vaccine research, development, and global health to support efforts to expand access to safe and effective COVID-19 vaccines.

COVID-19 Vaccine Development with BioNet

IVI was a member of a global consortium led by the French-Thai vaccine manufacturer BioNet, alongside Thailand’s Chulalongkorn University and the Universities of Pennsylvania and California-Davis in the United States, to conduct preclinical studies and clinical trials on a new COVID-19 vaccine.

Clinical Immunology Program

IVI’s Clinical Immunology Program developed, standardized, and validated assays to measure immune responses to vaccines in humans and established reference tests for the laboratory diagnosis of enteric and respiratory infections to support disease burden studies and clinical trials conducted by the Translational Research Division.

In 2008, IVI completed, in collaboration with the U.S. National Institutes of Health, the development of an enzyme-linked immunosorbent assay (ELISA) test for typhoid fever. This project received funding from the Bill & Melinda Gates Foundation.

E. coli in Egypt

From 1998 to 2000, IVI researchers worked with scientists from the Egyptian Ministry of Health and Population, the US Naval Medical Research Unit -3 in Cairo, the U.S. National Institutes of Health, the University of Gothenburg, Sweden, SBL vaccine, and SmithKline Beecham on a field trial of a killed oral vaccine against enterotoxigenic Escherichia coli (ETEC). This trial was the first ever efficacy study of an ETEC vaccine in infants and toddlers, who are at high risk for ETEC diarrhea in countries where ETEC is endemic.

Geographic Information System (GIS) Program

IVI’s GIS Program supported the Translational Research Division’s programs in the design, implementation, and analysis of disease surveillance and epidemiologic studies; studies of environmental risk factors for disease; and vaccine clinical trials. This project was completed in collaboration with the University of North Carolina at Chapel Hill and funded by the Bill & Melinda Gates Foundation and the U.S. National Institutes of Health.

Molecular Vaccinology Program

IVI’s Molecular Vaccinology Program focused on developing vaccines against shigellosis, severe acute respiratory syndrome (SARS), and influenza virus.

IVI received a Grand Challenges Explorations grant from the Gates Foundation in October 2009 to support its work on a cross-protective influenza vaccine based on the green fluorescent protein (GFP), which IVI scientists discovered has unexpected protective properties against influenza virus infection.

In collaboration with Chiron, Enteric Vaccine Initiative, PATH, the Johns Hopkins Bloomberg School of Public Health, NICED, Seoul National University, and the University of Maryland, IVI created a genome database for V. cholerae species in 2009, which contains more than 154 cholera isolates collected worldwide between 1910 and 2010.

PROVIDE: Performance of Oral Rotavirus and Poliovirus Vaccines in Developing Countries (2010-2016)

IVI took part in PROVIDE, a research study funded by the Bill & Melinda Gates Foundation that sought to uncover the role of tropical enteropathy on the immune response to oral vaccines. With the National Institute of Cholera and Enteric Diseases (NICED) of India, the University of Vermont, and the University of Virginia, IVI conducted an observational study in Kolkata, India.

Regional Antimicrobial Resistance Data Analysis for Advocacy, Response and Policy (RADAAR)

Until 2024, WHONET (Brigham and Women’s Hospital) worked in collaboration with IVI to carry out the RADAAR project. Under the thematic domain of Policy, Planning, and Advocacy, the RADAAR project focused on strengthening country capacities to translate antimicrobial resistance (AMR) data and evidence into effective policies. RADAAR aimed to improve the analysis, sharing, and use of AMR data across One Health sectors and to establish mechanisms that facilitate policy dialogue around AMR. The project also sought to create demand among policymakers for policy-relevant AMR data and analyses.

Respiratory Encapsulated Bacteria Program

IVI’s Respiratory Encapsulated Bacteria Program aimed to conduct epidemiologic studies in Asia to measure the actual disease burden of pneumococcus and answer key policy questions about the ultimate deployment of pneumococcal vaccines in public health practice. This project was completed in collaboration with PneumoADIP at Johns Hopkins University.

Respiratory Pathogen Vaccines Program

IVI’s Respiratory Pathogen Vaccines Program generated evidence on the disease burden caused by Haemophilus influenzae type b (Hib), Streptococcus pneumoniae (pneumococcus), and meningococcal disease—the three major causes of bacterial meningitis and pneumonia—and by influenza in Asian countries.

PneumoNet, a Pfizer-supported study, was conducted in 2009-2011 to better define the incidence of invasive pneumococcal disease and pneumococcal serotype distribution among children under five years of age in the Asia-Pacific region. The study involved conducting hospital-based surveillance in four countries (India, Indonesia, the Philippines, and Thailand). IVI completed this project in collaboration with U.S. partners, such as the Center for Vaccine Research, Harbor-UCLA Medical Center, Harvard School of Public Health, Quest Laboratories, and Quintiles. Funding was provided by the Centers for Disease Control and Prevention, Chiron, Merck, PATH, Pfizer, PneumoADIP, Johns Hopkins University, and Wyeth.

Rotavirus Diarrhea Vaccine Program

With funding from various U.S. institutions: CDC Foundation; Chiron; Merck; National Institutes of Health; PATH; Wyeth, IVI conducted a range of rotavirus vaccine studies and trials, including

Two years of surveillance for hospital-based rotavirus studies in sentinel hospitals in Cambodia, Laos, Mongolia, and Sri Lanka. Completed in 2007 with funding from the Rotavirus Vaccine program at PATH and continued until early 2009 with additional funding from the U.S. CDC Foundation.

A 2007 study of the cost of diarrheal disease and the cost-effectiveness of rotavirus vaccines in Vietnam. Completed in collaboration with the U.S. CDC and Emory University.

A phase III trial of the three-dose pentavalent oral rotavirus vaccine (RotaTeq®) in Khanh Hoa, Vietnam, conducted from 2007 to 2009 with support from the Rotavirus Vaccine Program at PATH.

An innovative pilot study between 2007 and 2010 involving prospective surveillance and reporting of rotavirus using handheld personal digital assistants (PDAs), funded by the U.S. NIH.

A surveillance study of rotavirus diarrhea among children under five years of age in Kolenchery, India, completed in 2011 with support from the U.S. NIH.

Supporting Independent Immunization and Vaccine Advisory Committees (SIVAC) (2008-2014)

The SIVAC Initiative was established in 2008 to support low- and middle-income countries (LMICs) in Asia and Africa in establishing or strengthening National Immunization Technical Advisory Groups (NITAGs), a key means through which countries make informed decisions about vaccine introduction and immunization programs. SIVAC was implemented jointly by IVI and Agence de Médecine Préventive (AMP) and supported by the Bill & Melinda Gates Foundation.

Between 2011 and 2013, SIVAC, in collaboration with the WHO Regional Offices and the U.S. CDC, organized training workshops for NITAG members from Central Asia and Eastern Europe in various countries including Belarus, Bhutan, Kazakhstan, and Turkey. This project was completed with funding from the Gates Foundation and in collaboration with the Centers for Disease Control and Prevention.

Tuberculosis Vaccine Development

IVI collaborated with Boston Children’s Hospital (BCH), the Harvard T.H. Chan School of Public Health, and Tulane University to develop a vaccine directed against Mycobacterium tuberculosis that uses the Multi Antigen Presentation System (MAPS) developed by BCH. This project was funded by an R01 grant from the U.S. National Institutes of Health.