IVI & the United States

 

American Leadership at IVI

IVI Senior Leadership
Jerome H. Kim, M.D., Director General
Julia Lynch, M.D., Director of Cholera Program
Dr. John D. Clemens, Senior Scientific Advisor (IVI Director General 2000-2010)

Board of Trustees (Present)
Chairperson George Bickerstaff, CRT Capital Group LLC/M.M. Dillion & Co. (2009- Present)
Dr. Anthony Ford-Hutchinson, Chief Science Officer, RiboNova Inc. (2019- Present)
Dr. Chris Varma, Vision Medicines Inc./Frontier Medicines Corporation (2017- Present)

Board of Trustees (Past)
Chairperson Professor Barry R. Bloom, Harvard School of Public Health (1995-2002; 2004-2011)
Dr. Roger I. Glass, National Institutes of Health (2006-2011)
Dr. Maurice Hilleman, Merck Institute of Therapeutic Research (1995-1996)
Professor Samuel Katz, Duke University Medical Center (2003-2007)
Dr. J. Joseph Kim, Inovio Pharmaceuticals (2014-2019)
Professor Margaret A. Liu, ProTherImmune (2007-2010)
Professor Adel A.F. Mahmoud, Princeton University (2010-2017)
Dr. George Poste, Arizona State University (2003-2006)
Dr. Regina Rabinovich, Bill & Melinda Gates Foundation (2005-2007)
Professor Philip K. Russell, Johns Hopkins Bloomberg School of Public Health (2003-2007)
Mr. Vijay Samant, Vical Inc. (2009-2011)
Dr. George R. Siber, ClearPath Vaccines (2014-2019)

Scientific Advisory Group (Present)
Chairperson Dr. Christian W. Mandl, Vaccines and Viral Vectors (2018- Present)
Dr. Vincent I. Ahonkhai, Gwynedd Consultancy Group LLC (2018- Present)
Susan Barnett, Senior Program Officer- HIV Vaccines, Bill & Melinda Gates Foundation (2021- Present)
Dr. Roger I. Glass, National Institutes of Health (2016-2020)
Dr. Richard A. Koup, National Institutes of Health (2016- Present)
Professor Myron “Mike” Levine, University of Maryland School of Medicine (2016- Present)
Professor Moon H. Nahm, University of Alabama at Birmingham (2001- Present)
Professor Mathuram Santosham, Johns Hopkins Bloomberg School of Public Health (2016- Present)
Theodore Tsai, Head of Immunization Science and Policy, Takeda Vaccines (2021- Present)

Scientific Advisory Group (Past)
Professor Robert E. Black, Johns Hopkins Bloomberg School of Public Health (2001- 2014)
Dr. Tim Endy, Department Chair, SUNY Upstate Medical University (2016)
Professor Margaret A. Liu, Karolinska Institute (2000- 2012)
Professor. Ira M. Longini, Jr., University of Washington (2007-2010)
Dr. John La Montagne, National Institute of Allergy and Infectious Diseases (2001)
Professor Pearay L. Ogra, University of Texas/State University of New York (2003-2014)
Dr. David A. Sack, Johns Hopkins Bloomberg School of Public Health (2012-2014)

Ongoing IVI-US Collaboration

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

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

American Partners: Brigham and Women’s Hospital; Public Health Surveillance Group

Cholera Vaccine Program

American Funder: Bill & Melinda Gates Foundation

American Partners: Johns Hopkins University; Massachusetts General Hospital; University of Maryland

Inovio COVID-19 Vaccine Research & Development
IVI is supporting clinical development of INOVIO’s COVID-19 vaccine candidate by conducting a Phase I/IIa clinical trial at four sites in South Korea to demonstrate tolerability, safety, and immunogenicity.

American Partner: INOVIO Pharmaceuticals

Covid-19 Vaccine Development with BioNet
IVI is a member of a global consortium led by the French-Thai vaccine manufacturer BioNet, alongside Thailand’s Chulalongkorn University and the Universities of Pennsylvania, North Carolina, and California-Davis in the United States, to conduct preclinical studies and clinical trials on a new COVID-19 vaccine. The program is made possible by a $200 million USD grant from CEPI, the Coalition for Epidemic Preparedness Initiative.

American Partners: University of Pennsylvania, University of North Carolina, University of California-Davis

Hepatitis E Vaccine Roadmap

IVI and its partners are contributing to the development of a roadmap to identify the key remaining barriers to wider availability and use of Hepatitis E vaccine Hecolin®. As part of this project, IVI
will identify and prioritize clinical evidence gaps to inform policy and meet requirements (SAGE, 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. Work began in mid-2021 with the first meeting of the Policy Advisory Group and Technical Advisory Group.

American Funder: Bill & Melinda Gates Foundation (grant to Johns Hopkins University)

American Partners: Johns Hopkins University; Syracuse University

HPV Vaccine Study Program

The IVI HPV Vaccine Study Program aims to demonstrate the effectiveness and affordability of a single-dose of HPV vaccine. It is funded by a 5-year, $6.4 million grant from the Bill & Melinda Gates Foundation.

In 2018, IVI completed agreements and laboratory preparations with various institutions including the U.S. CDC and established links with the HPV Consortium led by PATH and funded by the Bill & Melinda Gates Foundation.

American Funder: Bill & Melinda Gates Foundation

American Partners: Centers for Disease Control and Prevention; PATH

Japanese Encephalitis Vaccine Program

IVI is evaluating the protective effectiveness of the Chengdu SA14-14-2 JE vaccine by conducting JE disease surveillance in all 24 hospitals and health centers in Bali, Indonesia as a follow-up to a 2018 mass vaccination campaign funded and coordinated by the Indonesian Ministry of Health and Gavi, the Vaccine Alliance. The campaign provided the JE vaccine to over 890,000 Balinese children.

American Funder: PATH

American Partners: Centers for Disease Control and Prevention; PATH

Severe Typhoid in Africa Program (SETA/SETA Plus)
Press Release

SETA Plus is a continuation of IVI’s typhoid surveillance programs in Africa, which began in 2010 with the Typhoid Fever Surveillance in Africa Program (TSAP) and continued from 2015 with the SETA program, a multi-country surveillance study to understand the burden of severe typhoid fever and the associated case fatalities, clinical characteristics, and potential host risk factors that may be related to the disease severity.

SETA Plus will continue to collect standardized data from five sub-Saharan African countries (Ghana, the Democratic Republic of the Congo, Nigeria, Madagascar, and Burkina Faso), including additional information on invasive Salmonella infections, such as severe manifestations of the illness and socio-economic burden.

American Funder: Bill & Melinda Gates Foundation

Shigella Vaccine Development
IVI’s Shigella vaccine development program is a follow-up to IVI’s 2001-2005 DOMI Shigella Program. In 2020, IVI began the optimization and analysis of 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.

American Funder: PATH

American Partners: PATH; University of Georgia; Walter Reed Army Institute of Research

Strep A Global Vaccine Consortium (SAVAC)

The SAVAC Consortium convenes global health representatives to develop a vaccine for Group A Streptococcus, the disease responsible for rheumatic heart disease and the cause of over half a million deaths each year.

American Partners: Harvard School of Public Health; PATH; University of Colorado

Tuberculosis Vaccine Development

IVI is collaborating with Boston Children’s Hospital (BCH), the Harvard T.H. Chan School of Public Health, and Tulane University on the development of a vaccine directed against Mycobacterium tuberculosis that uses the Multi Antigen Presentation System (MAPS) developed by BCH. This project is funded by a R01 U.S. NIH grant.

American Funder: National Institutes of Health

American Partners: Boston Children’s Hospital; Harvard T.H. Chan School of Public Health; Tulane University

Typhoid Vaccine Program

IVI has completed the development of a typhoid conjugate vaccine, which promises to protect infants under two years of age, as well as young children, against typhoid fever and provide a longer duration of protection than other typhoid vaccines.

American Funders: Bill & Melinda Gates Foundation; CDC Foundation

American Partners: Centers for Disease Control and Prevention; National Institutes of Health

Typhoid Conjugate Vaccine Introduction in Africa (THECA)

American Funder: Bill & Melinda Gates Foundation

American Partner: Center for Vaccine Development and Global Health, University of Maryland School of Medicine

Vaccine Against Schistosomiasis for Africa (VASA)

American Partners: PAI Life Sciences Inc.; Texas Tech University Health Sciences Center

Previous IVI-US Collaboration

IVI Vaccinology Course
American Funders: Bill & Melinda Gates Foundation (2000-2010; 2012); Pfizer (2012-2016); Rockefeller Foundation (2000-2004)

Scholars in Residence Program
Professor Robert Black, Johns Hopkins Bloomberg School of Public Health (2013)
Professor David Goldblatt, Institute of Child Health (2007)
Dr. Jacqueline Katz, Centers for Disease Control and Prevention (2006)
Professor. Ira M. Longini, Jr., University of Washington (2006)
Dr. Jiri Mestecky, University of Alabama at Birmingham (2008)
Dr. Pearay L. Ogra, State University of New York at Buffalo (2013)
Professor Peter Palese, Mount Sinai School of Medicine (2006)
Dr. John Robbins, National Institutes of Health (2006)
Dr. David A. Sack, Johns Hopkins Bloomberg School of Public Health (2013)
Dr. John Schiller, National Institutes of Health (2006)
Dr. Richard Ward, Cincinnati Children’s Hospital Medical Center (2008)

Diseases of the Most Impoverished (DOMI) (2000-2008)
A grant of $40 million was awarded to IVI in 2000 by the Bill & Melinda Gates Foundation, the first major grant to IVI from the foundation, to support DOMI, a program of research and technical assistance to accelerate the rational introduction of vaccines against cholera, typhoid fever, and shigellosis into public health programs for the poor in developing countries. DOMI operated in seven countries in Asia (Bangladesh, China, India, Indonesia, Pakistan, Thailand, and Vietnam) and one country in Africa (Mozambique).

American Funders: AVANT Immunotherapeutics; Bill & Melinda Gates Foundation; Emergent BioSolutions; Rockefeller Foundation; University of Alabama at Birmingham

Cholera Programs (DOMI, CHOVI) 2000-2011

American Funder: Bill & Melinda Gates Foundation

American Partners: Celldex Therapeutics (formerly AVANT Immunotherapeutics); Harvard University

Typhoid Programs (DOMI, TSAP, VIVA) 2000- Present

American Funders: Bill & Melinda Gates Foundation

American Partners: National Institutes of Health

E Coli in Egypt (2000-2002)

American Partners: U.S. Naval Medical Research Units 2 & 3; National Institutes of Health

Geographic Information System (GIS) Program
IVI’s GIS Program provided support to 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.

American Funders: Bill & Melinda Gates Foundation; National Institutes of Health

American Partner: University of North Carolina at Chapel Hill

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

In 2008, IVI completed, in collaboration with the U.S. NIH, the development of an enzyme-linked immunosorbent assay (ELISA) test for typhoid fever.

American Funder: Bill & Melinda Gates Foundation

American Partner: National Institutes of Health

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

A Grand Challenges Explorations grant from the Bill & Melinda Gates Foundation was provided to IVI in October 2009 to support its work on a cross-protective influenza vaccine based on the green fluorescent protein (GFP), discovered by IVI scientists to have unexpected protective properties against influenza virus infection.

In collaboration with icddr,b, 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.

American Funders: Bill & Melinda Gates Foundation; PATH

American Partners: Chiron; Enteric Vaccine Initiative, PATH; Johns Hopkins Bloomberg School of Public Health; University of Maryland

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.

American Funder: Bill & Melinda Gates Foundation

American Partners: University of Vermont, University of Virginia

Dengue Programs (PDVI, DVI, GADC) 2002-2018

American Funders: Bill & Melinda Gates Foundation; Rockefeller Foundation; US NIH

American Partners: Centers for Disease Control and Prevention (US CDC); Colorado State University; Global Solutions for Infectious Diseases; Hawaii Biotech; Henry H. Jackson Foundation; Inviragen; Johns Hopkins Bloomberg School of Public Health; National Institutes of Health (US NIH); Purdue University; Saïd Business School, Scripps Research Institute; The Heller School for Social Policy and Management, Brandeis University; University of California, Berkeley; University of Hawaii; University of North Carolina at Chapel Hill; University of Rochester Medical Center; University of Texas Medical Branch at Galveston; Walter Reed Army Institute of Research; Washington University, Sabin Vaccine Institute; Duke-NUS Medical School; International Vaccine Access Center (IVAC) at the Johns Hopkins Bloomberg School of Public Health

Respiratory Encapsulated Bacteria Program
IVI’S Respiratory Encapsulated Bacteria Program aimed to conduct epidemiologic studies in Asia that measure the actual disease burden of pneumococcus in order to answer key policy questions about the ultimate deployment of pneumococcal vaccines in public health practice.

American Partner: 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).

American Funders: Centers for Disease Control and Prevention; Chiron; Merck; PATH; Pfizer; PneumoADIP, Johns Hopkins University; Wyeth

American Partners: Center for Vaccine Research, Harbor-UCLA Medical Center; Harvard School of Public Health; Quest Laboratories; Quintiles

Rotavirus Diarrhea Vaccine Program
With funding various U.S. institutions, 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; and
  • 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

American Funders: CDC Foundation; Chiron; Merck; National Institutes of Health; PATH; Wyeth

American Partners: Centers for Disease Control and Prevention (US CDC); Emory University; Family Health International; National Institutes of Health (US NIH); PATH

Studies on Invasive Bacterial Diseases 1999-2003, 2006-2007
IVI carried out population-based surveillance of bacterial meningitis in China, South Korea, and Vietnam from 1999 to 2003, and influenza surveillance in Cambodia from 2006 to 2007. These studies were unique because they were some of the first epidemiological studies on invasive bacterial diseases that included methods for testing spinal fluid by polymerase chain reaction (PCR).

American Funders: Centers for Disease Control and Prevention (US CDC); Merck

Supporting Independent Immunization and Vaccine Advisory Committees (SIVAC) Initiative (2008-2014)
The SIVAC Initiative was established in 2008, with the aim to support to 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 are able to 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 BITAG members from Central Asia and Eastern Europe in various countries including Belarus, Bhutan, Kazakhstan, and Turkey.

American Funder: Bill & Melinda Gates Foundation

American Partner: Centers for Disease Control and Prevention

Other Activities
2006: The United States Agency for International Development (USAID) funded a four-day Workshop on Clinical Trial Design, Monitoring and Evaluation for members of the Developing Country Vaccine Manufacturers Network (DCVMN), held at IVI in September.

2010: The International Symposium on Hepatitis E was held in Seoul in September in collaboration with the WHO and with support from the Bill & Melinda Gates Foundation and the U.S. CDC.

2011: IVI scientists co-organized a Keystone Symposium on “Malnutrition, Host-Microbial Interactions and Gut Immunity to Vaccines” held in New Delhi, India in November with support from the Bill & Melinda Gates Foundation and the U.S. NIH.