Ivi brochure 2004

19
Vaccines, Children and a Better World

description

Ivi brochure 2004

Transcript of Ivi brochure 2004

Page 1: Ivi brochure 2004

Vaccines, Childrenand a Better World

Page 2: Ivi brochure 2004
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p 3 .......Letter from the Director

p 4 .......Goal and Mission

The IVI and the Millenium Development Goals

p 5 .......Historical Landmarks

p 6 .......Board of Trustees

p 7 .......Scientific Advisory Group

p 8 .......Signatory Countries

Recent Growth

p 9 .......The IVI's Achievements

Organizational Structure

p 10 .....Divisions of the IVI

Translational Research Division

Laboratory Sciences Division

Training and Technical Assistance Division

p 15 .....Future Directions of the IVI

p 16 .....Donors to the IVI

Korea Support Committee

p 17 .....International Collaborators

Contents

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Dr. John D. Clemens, Director of the IVI, is an international expert on vaccine evaluation in

developing countries. Before joining the IVI in 1999, he held senior positions at the United States

National Institutes of Health. He has been a long-term advisor to the World Health Organization(WHO)

and serves in a continuing appointment as an adjunct professor at Johns Hopkins University

Dear Friends,We live in an extraordinarily exciting era in which the fruits of biotechnology offer the prospect of new vaccines against diseases for which no

previous vaccines existed and of vastly improved versions of existing vaccines. While this revolution in vaccinology provides breathtaking

prospects for disease prevention, it is sobering to note that many vaccines that are routine public-health tools for the industrialized world are not

used in programs for the poor in the developing world, and that the discovery of vaccines against diseases that primarily afflict the developing

world has been painfully slow due to a lack of economic incentives.

The International Vaccine Institute (IVI), located in Seoul, the Republic of Korea, was established to assist efforts to close the gap between

vaccines for the developing world versus the industrialized world by conducting research and delivering technical assistance. The IVI is the world's

only international research organization devoted solely to bringing new vaccines to the poor populations of the developing world. To date, 35

countries and the WHO have signed the IVI Establishment Agreement.

The work and the growth of the IVI is part of a larger revolution in public-sector commitment to close the gap between vaccines for the rich and the

poor. The Global Alliance for Vaccines and Immunization (GAVI) has been extraordinarily successful in mobilizing new support for the purchase

and deployment of needed vaccines in the public-health programs of developing countries and has recently launched support for research on new

vaccines and vaccine technologies. In addition, various organizations such as the Bill & Melinda Gates Foundation and the United States National

Institutes of Health are committing greatly increased resources for vaccine research and development. There have been major changes in the

vaccine industry both in developed and developing countries. With respect to the latter, an ongoing story of great import is the astonishing

evolution of many producers in developing countries.

During the years since the IVI was established in 1997, the Institute has become an important partner in global efforts to develop and deploy new

vaccines for the poor. It has launched major programs of field research on new vaccines against diarrheal, respiratory, and flavivirus infections in

21 countries of Asia, Africa and Latin America. It has also provided technical assistance in vaccine production, regulation, and evaluation to

professionals in 15 countries in Asia, Africa, and Latin America.

The IVI's growth has been made possible by generous support from an increasing number of donors. The Republic of Korea has played a pivotal

role in this respect, providing a portion of the IVI's operating budget, as well as a new headquarters building with state-of-the-art laboratories. The

recent completion of this beautiful building, located on the campus of Seoul National University, has allowed the Institute to launch an exciting new

laboratory sciences program that will greatly increase the IVI's ability to contribute to the enterprise of bringing vaccines to developing countries.

In closing, I would like to acknowledge the importance to our programs of the collaboration of many institutions and individuals, from both the

private and public sectors and from both the industrialized and developing worlds. And I would like to thank especially the scientists, public-health

officials, and other collaborators in developing countries who have allowed us to join with them in their work to reduce morbidity and mortality in

their countries. It has been an honor to have shared the hopes and aspirations of these dedicated persons.

Sincerely,

3

Letter from the Director

John Clemens

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At the United Nations Millennium Summit in September 2000 world leaders placed development at the heart of the global agenda by adopting the

Millennium Development Goals (MDGs), which set clear targets for reducing poverty, hunger, disease, illiteracy, environmental degradation, and

discrimination against women by 2015. The eight Millennium Development Goals constitute an ambitious agenda to significantly improve the

human condition by 2015. The IVI is actively working to make a valuable contribution to achieving the MDGs.

Millennium Development Goal 1, "Eradicate extreme poverty and hunger". By preventing unnecessary deaths and allowing

people, especially children, to lead healthy lives, the IVI contributes to alleviating poverty and strengthening economies.

Millennium Development Goal 4, "Reduce child mortality". The research programs at the IVI contribute to the target of

reducing by two-thirds, between 1990 and 2015, the under-five mortality rate by addressing new-generation vaccines against diarrhea and

respiratory infections, and against Japanese encephalitis and dengue fever. Together these diseases claim the lives of nearly five million persons

each year, most of whom are children living in impoverished conditions in developing countries.

Millennium Development Goal 8, "Develop a global partnership for development". The mission of the IVI is to develop and

accelerate the introduction of new vaccines at affordable prices into the public-health programs of developing countries. The IVI facilitates transfer

of vaccine technology to pharmaceutical companies in developing countries to create cost-effective vaccines for the world's poor. The Institute also

provides training and technical assistance for the clinical evaluation of vaccines and vaccine production and regulation to professionals in

developing countries.

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The IVI and the Millenium Development Goals

Goal

The International Vaccine Institute is founded on the belief that the health of children in developing countries can be dramatically improved by the development, introduction, and use of new and improved vaccines and that these vaccines should be developed through a dynamic interaction among science, public health, and industry.

Mission

The International Vaccine Institute will contribute to the reduction of vaccine preventable diseases in developing countries by collaborative research that generates the evidence needed for rational introduction of new vaccines, supported by programs of basic and applied laboratory research, product development, training, and technical assistance.

Goal and Mission

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September 2004 Kwon Yang-suk, First Lady of Korea, becomes the Honorary President of the Korea Support

Committee for the IVI.

July 2003 Launch of the Pediatric Dengue Vaccine Initiative (PDVI) with a $55 million grant from Bill & Melinda

Gates Foundation.

June 2003 The IVI Board of Trustees elects Prof. Samuel Katz as its new chairman.

June 2003 Opening of the new headquarters building, generously donated by the Government of Korea, and initiation

of the IVI's new Laboratory Sciences Division.

March 2002 The Board of Trustees meet with Kim Dae-jung, President of the Republic of Korea, at the presidential

office at Cheong Wa Dae.

January 2000 Launch of the Diseases of the Most Impoverished (DOMI) Program with a $40 million grant from

Bill & Melinda Gates Foundation.

April 1999 Lee Hee-ho, First Lady of Korea, becomes the Honorary President of the Korea Support Committee

for the IVI.

April 1999 The Board of Trustees appoints Dr. John Clemens as the first Director of the IVI.

January 1999 The National Assembly of the Republic of Korea ratifies the Headquarters Agreement between the IVI

and the Republic of Korea, bringing it into full effect.

October 1997 Inaugural meetings of the governing Board of Trustees and the Institute Support Council convene

in Seoul, with Prof. Barry Bloom as the Board's first Chairman. The Board approves the first Strategic Plan for the IVI.

May 1997 The IVI's establishment goes into effect after receiving three ratifications at United Nations Headquarters in

New York.

December 1995 The Government of Korea (Ministry of Education and Human Resources Development) sets up

special task force at Seoul National University for the establishment of the IVI (Chaired by Prof. Park Sang Dai).

April 1995 First meeting of the Advisory Board of Trustees at the United Nations Development Programme (UNDP)

Headquarters in New York.

January 1995 UNDP opens an interim office of the IVI on the campus of Seoul National University in Seoul,

the Republic of Korea.

September 1994 The Administrator of UNDP and the Permanent Representative of the Republic of Korea to the

United Nations exchange letters confirming the designation of the Republic of Korea as the host country of the IVI.

June 1994 The Site Selection Committee, meeting at UNDP, recommends that the IVI be located in Seoul,

the Republic of Korea, and that the Institute carry out its activities through close partnerships with centers of excellence

in other countries in the region.

March 1994 Six Asian countries submit proposals to UNDP to host the IVI.

September 1993 Based on a feasibility study, a formal proposal to establish the IVI in a developing country in

Asia is adopted by UNDP.

September 1990 The World Summit on Children at the United Nations adopts a declaration calling for

concerted international action to promote children's health in developing countries, eventually leading to the creation of the

Children's Vaccine Initiative (CVI).

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Historical Landmarks

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Board of TrusteesProf. Samuel Katz - Chairman Professor Emeritus, Department of Pediatrics, Duke University Medical Center, Durham, North Carolina, USA

Dr. Michel Greco Former President, Aventis Pasteur, Lyon, France

Mr. Joon Oh Director General,Office of Policy Planning and International Organizations, Ministry of Foreign Affairs & Trade, Seoul, Republic of Korea

Dr. Shigeru Omi Regional Director,WHO Regional Office for the Western Pacific (WPRO), Manila, The Philippines

Dr. Samlee Plianbangchang Regional Director, WHO Regional Office for South-East Asia (SEARO),New Delhi, India

Dr. George Poste Director, The Biodesign Institute at Arizona State University,Tempe, Arizona, USA

Prof. Philip K. Russell Professor Emeritus, Johns Hopkins Bloomberg School of Public Health,Baltimore, Maryland, USA

Prof. Ian David Gust Professor Emeritus,University of Melbourne, Victoria, Australia

Dr. Nay Htun Professor and Executive Director,University for Peace, New York, USA

Prof. Paul-Henri Lambert Professor, Department of Pathology, University of Geneva,Geneva, Switzerland

Dr. Hanna Maria Nohynek Department of Vaccines, National Public Health Institute, Helsinki, Finland

Prof. Jan Holmgren - Vice Chairman Professor,Department of Medical Microbiology & Immunology,University of Gothenburg, Gothenburg, Sweden

Prof. Maharaj Krishnan Bhan Secretary,Department of Biotechnology, Ministry of Science and Technology, New Delhi, India

Dr. John D. Clemens Director, International Vaccine Institute, Seoul, Republic of Korea

Prof. Gordon Dougan Professor,Center for Molecular Microbiology and Infection, Department of Biological Science, Imperial College of Science, Technology and Medicine, London, United Kingdom

From the left to right in the first row, Dr. John D. Clemens, Prof. Sam L. Katz, Dr. Hanna Maria Nohynek, Prof. Myung-Hee Chung, Dr. Shigeru Omi, Mr. Joon Oh

In the second row, Prof. Margaret Liu, Prof. Geoffrey Schild, Dr. Michel Greco, Prof. Ian David Gust, Prof. Philip Russell, Prof. Gordon Dougan, Prof. Jan Holmgren, Prof. Paul-Henri Lambert

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Prof. Margaret Liu, the Chairperson of SAG, is at the head of table in the SAG meeting held at IVI headquarters in 2003.

The IVI Scientific Advisory Group (SAG), established in 2000, is composed of international experts in vaccine sciences and public health. The SAG meets yearly to review the scientific

programs of the Institute and to advise the Director.

Prof. Michael Good Director, Queensland Institute of Medical ResearchBrisbane, Australia

Dr. Costante Ceccarini Independent Consultant,Vaccine Research and Development, Sienna, Italy

Prof. Margaret Liu - Chairperson Vice-Chairman, Transgene, Lyon, France, and Visiting Professor, Karolinska Institute, Stockholm, Sweden

Prof. Robert E. Black Chairman, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore,

Prof. Moon Nahm Professor,Department of Pathology,University of Alabama School of Medicine,Birmingham, Alabama,USA

Prof. Sun Young Kim Professor,Institute of Molecular Biology and Genetics,Seoul National University, Seoul, Republic of Korea

Prof. Stefan Kaufmann Director,Department of Immunology,Max Planck Institute for Infection Biology, Berlin, Germany

Prof. Yoshifumi Takeda Professor,Department of Food and Health SciencesJissen Women's University, Tokyo, Japan

Prof. Rho Hyun Seong Associate Professor,Institute of Molecular Biology & Genetics,Seoul National University, Seoul, Republic of Korea

Prof. Peary L. Ogra Professor Emeritus,Department of Pediatrics,State University of New York at Buffalo, Buffalo, New York, USA

Dr. Elwyn Griffiths Associate Director, General Biologics and Genetic Therapies Directorate, Health Canada, Ottawa, Canada

Scientific Advisory Group

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Signatory Countries

World HealthOrganizationVietnam�TurkeyThailandTajikistanSwedenSri Lanka

SlovakRepublic

SenegalRomaniaPanamaPakistanOman

NetherlandsNepalMyanmar Mongolia�MaltaLebanon

Jamaica�IsraelIndonesiaEcuador EgyptChinaBrazilBhutanBangladesh

Yearly Budget and Personnel Graph

1997 19992001

2003

2005(projected)

2005(projected)

105

93

70

50

40

30

1012

18

18,000,000

1997 19992001

2003

16,000,000

14,000,000

12,000,000

10,000,000

8,000,000

4,000,0006,000,000

2,000,000

Recent Growth

8

Budget Growth since 1997Staff Growth since 1997

Republic ofKorea

Kazakhstan Kuwait� Kyrgyzstan�

Papua New Guinea Peru�

Uzbekistan

The IVI has experienced rapid growth in its budget and staff since its creation in 1997 Its staff now numbers 93 and comes from

16 countries in Asia, Africa, Europe, North America, and Australia.

Philippines�

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IVI s Achievements

Organizational Structure

Since its establishment in 1997, the IVI has:

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Established major research programs in 21 countries of Asia, Africa and Latin America

- Determine the disease burden of invasive bacterial infections of childhood, especially Haemophilus influenzae type b (Hib)

- Assess the disease burden of rotavirus diarrhea in children

- Accelerate the development and provide evidence for rational introduction of vaccines against cholera, shigellosis,

and typhoid fever (the Diseases of the Most Impoverished Program)

- Accelerate the development and introduction of new vaccines against dengue fever for public-health programs

for the poor in Asia and Latin America (The Pediatric Dengue Vaccine Initiative)

- Provide evidence for the rational introduction of vaccines against Japanese encephalitis into programs for children in Asia

- Assess the efficacy of new vaccines against enterotoxigenic Escherichia coli

- Develop model systems for assessing the safety of vaccines used in developing countries

Initiated a program of laboratory research at the IVI headquarters in Seoul that addresses topics in immunology,

molecular microbiology, and vaccine development and process research.

Provided training and technical assistance to professionals in Asia and Africa on:

- Clinical evaluation of vaccines

- Vaccine production and regulation

Established a group of affiliated laboratories in Korea and a network of collaborating laboratories in

Europe and the United States.

Established a post-doctoral training program in the network of IVI's collaborating laboratories.

BOARD OF TRUSTEES

TRANSLATIONALRESEARCH LABORATORY SCIENCES

DEPUTY DIRECTOR

ADMINISTRATION ANDFINANCE

DEPUTY DIRECTOR

COMPUTER SERVICES

ACCOUNTING ANDFINANCE

BUILDING ANDMAINTENANCE

HUMAN RESOURCESAND ADMINISTRATIVESUPPORT SERVICES

LIBRARY ANDINFORMATION

SERVICES

IMMUNOLOGY

MOLECULARMICROBIOLOGY

VACCINEDEVELOPMENT

HEAD

EPIDEMIOLOGY ANDCLINICAL TRIALS

BIOSTATISTICS

DATA MANAGEMENT

PROGRAM SUPPORT

ECONOMICS,SOCIOBEHAVIORAL AND

POLICY RESEARCH

DIRECTOR

INSTITUTE SUPPORT COUNCIL

OFFICE OF THE ASSOCIATE DIRECTOR FOR PROGRAMS, PARTNERSHIPS, AND

INSTITUTIONAL DEVELOPMENT

INSTITUTIONAL REVIEW BOARD SCIENTIFIC ADVISORY GROUP SPECIAL ADVISORS

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Translational Research Division

Divisions of the IVI

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Activities (countries participating):

- Epidemiologic studies of disease burden (Brazil, Cambodia, El Salvador, Malaysia, Panama, Thailand, Venezuela)

- Development of field sites for cohort studies and preparation for vaccine trials (Nicaragua)

- Policy research on vaccine introduction (Cambodia, Indonesia, Thailand, Vietnam)

- Research to develop tests that predict the risk of dengue hemorrhagic fever and the molecular basis of dengue pathogenisis

2. The Pediatric Dengue Vaccine Initiative (PDVI)

Donor support: Bill & Melinda Gates Foundation; Ministry of Education and Human Resources Development, Republic of Korea;

Rockefeller Foundation.

Goal: The Pediatric Dengue Vaccine Initiative (PDVI) is a program of research designed to provide the evidence needed to accelerate the

development and begin the introduction of new vaccines against dengue fever into public-health programs for children in developing countries.

Activities (countries participating):

- Epidemiologic studies of disease burden (Bangladesh, China, India, Indonesia, Mozambique, Pakistan, Thailand, Vietnam)

- Clinical trials of experimental vaccines (Bangladesh, India,Vietnam)

- Demonstration projects of existing vaccines (China, India, Indonesia, Mozambique, Pakistan, Vietnam)

- Studies of the economic cost of illness and of the cost-effectiveness of vaccinating (Bangladesh, China, India, Indonesia,

Mozambique, Pakistan, Thailand, Vietnam)

- Sociobehavioral studies of perceptions of Cholera, Shigellosis, and typhoid fever and the need for vaccination (Bangladesh, China, India, Indonesia,

Pakistan, Thailand, Vietnam)

- Policy research on vaccine introduction (Bangladesh, China, India, Indonesia, Mozambique, Pakistan, Thailand, Vietnam)

- Technical assistance in vaccine research and production (Bangladesh, China, India, Indonesia, Mozambique, Pakistan, Thailand, Vietnam)

- Vaccine-production technology transfer (China, India, Indonesia, Pakistan, Vietnam)

1. Diseases of the Most Impoverished (DOMI) Program

Donor support: Bill & Melinda Gates Foundation; Japan International Cooperation Agency; Ministry of Education and Human Resources

Development, Republic of Korea; GlaxoSmithKline; Sartorius; Wellcome Trust Labs.

Goal: The Diseases of the Most Impoverished (DOMI) Program is a program of research, technical assistance, and technology transfer for vaccine

production designed to accelerate the rational introduction of new-generation vaccines against cholera, shigellosis, and typhoid fever into public-health

programs of selected developing countries in Asia and Africa.

The Translational Research Division of the IVI conducts the diverse types of research needed to provide the evidence required by policy makers to introduce new vaccines into public-health programs for the poor in developing countries. These studies include assessments of the disease burden and risk factors for specific diseases in different populations; clinical trials and demonstration projects of vaccines; economic analyses of the cost-effectiveness of introducing new vaccines; behavioral assessments of the public demand and willingness to pay for new vaccines; and policy assessments of the feasibility and financial sustainability of introducing new vaccines. The multidisciplinary group of scientists in this division include experts in epidemiology, clinical trials, computer sciences, biostatistics, economics, behavioral sciences, and policy analysis.

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Activities (countries participating):

- Studies of the disease burden and economic costs of rotavirus diarrhea (Cambodia, China, Korea, Laos, Mongolia, Sri Lanka, Vietnam)

- Studies of the background incidence of intussusception, against which the safety of future rotavirus vaccines can be measured (China, Vietnam)

6. Program on New Systems for Assessing Vaccine Safety in Developing Countries

Donor support: Government of Japan; Ministry of Education and Human Resources Development, Republic of Korea;

United Nations Development Programme.

Goal: The Program on New Systems for Assessing Vaccine Safety in Developing Countries focuses on innovative methods for

monitoring vaccine safety and for assessing hypotheses about alleged vaccine side-effects in developing countries.

Activities (countries participating):

- Development of dynamic, large-linked databases for assessing rare but serious side-effects (Vietnam)

5. Program on the Introduction of Vaccines against Rotavirus Diarrhea

Donor support: The Children's Vaccine Program at PATH;Chiron; GlaxoSmithKline; Merck; Ministry of Education and Human Resources

Development, Republic of Korea; Wyeth.

Goal: The Program on the Introduction of Vaccines against Rotavirus Diarrhea conducts research to provide the evidence needed for the

introduction of new vaccines against childhood rotavirus diarrhea into routine infant immunization programs.

Translational Research Division

Activities (countries participating):

- Epidemiologic studies of the disease burden (Cambodia, India, Indonesia, Vietnam)

- Clinical studies of long-term neurobehavioral sequelae (China)

- Demonstration projects of existing vaccines (Vietnam)

- Studies of the economic cost of illness and of the cost-effectiveness of vaccinating (China, Indonesia, Thailand, Vietnam)

- Policy research on vaccine introduction (China, Indonesia, Thailand, Vietnam)

3. Japanese Encephalitis Vaccine Program

Donor support: Korea International Cooperating Agency (KOICA); Ministry of Education and Human Resources Development, Republic of

Korea; The Children's Vaccine Program at PATH.

Goal: The Japanese Encephalitis Vaccine Program is a program of research to provide the evidence necessary for rational policies on the

introduction of vaccines against Japanese encephalitis into public-health programs for poor populations living in developing countries of Asia.

Activities (countries participating):

- Studies of the disease burden of bacterial meningitis (China, Korea, Vietnam)

- Studies of the disease burden of bacterial pneumonia (China, Korea, Vietnam)

4. Program on Vaccines for Invasive Bacterial Diseases of Childhood

Donor support: Aventis Pasteur; The Children's Vaccine Program at PATH;Chiron; GlaxoSmithKline; Merck; Ministry of Education and

Human Resources Development, Republic of Korea; Wyeth.

Goal: The Program on Vaccines for Invasive Bacterial Diseases of Childhood seeks to provide an improved evidence base of disease-burden

statistics to assist the rational introduction of new-generation vaccines against Haemophilus influenzae type b, Streptococcus pneumoniae, and

Neisseria meningitidis into public-health programs for children in Asia.

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2. Laboratory of Mucosal Immunology

Donor support: Japan Society for the Promotion of Science; Korea Science and Engineering Foundation; Ministry of Education and Human

Resources Development, Republic of Korea; Swedish International Development Cooperation Agency.

Goal: This laboratory conducts research to better understand fundamental aspects of the mucosal immune response and to exploit this

information to develop effective vaccines that can be administered without needles.

Activities:

- Characterization of the basic mucosal immune system during bacterial invasion

- Development of novel mucosal delivery systems and adjuvants

- Investigation of knock-out mice to define new immune correlates of protection

1. Laboratory of Cellular and Humoral Immunology

Donor support: Bill & Melinda Gates Foundation; Korea Research Institute of Bioscience and Biotechnology; Microscience;

Ministry of Education and Human Resources Development, Republic of Korea; Swedish International Development Cooperation Agency.

Goal: This laboratory focuses on developing assays to evaluate the immune responses in humans after vaccination in clinical and field trials.

The aim of this laboratory is to investigate the immunity induced by both parenteral and mucosal vaccines against bacterial diseases, with a

particular emphasis on vaccines against cholera and typhoid fever. Particular attention is devoted to simplifying assays in order that they can

be adapted to laboratories in developing countries and used for pediatric vaccines studies in these settings.

Activities:

- Assessment of antibacterial cell-mediated immunity

- Evaluation of antibody responses to both bacterial protein and non-protein antigens

- Development of improved tests for evaluating immunological memory at the B and T cell level

The Laboratory Sciences Division of the IVI was initiated in 2003, upon completion of the new headquarters building. The division undertakes diverse research to accelerate the development, evaluation, and introduction of new vaccines into developing countries, and prioritizes research that will support the research being undertaken by the Translational Research Division. Current major areas of emphasis include immunology (humoral, cellular, and mucosal); molecular microbiology; and vaccine development. The division currently employs 20 PhDs and research assistants operating in 5,000 square meters of laboratories equipped with state-of-the-art instruments.

Laboratory Sciences Division

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3. Laboratory of Molecular Microbiology

Donor support: Korea Research Foundation; Ministry of Education and Human Resources Development, Republic of Korea; Ministry

of Science and Technology, Republic of Korea; Science and Engineering Foundation; Swedish International Development Cooperation

Agency.

Goal: This laboratory uses molecular biology techniques and bioinformatics to better understand the molecular epidemiology,

pathogenetic mechanisms, and genetic diversity of bacterial pathogens, with a special focus on Vibrio cholerae, Salmonella, and

Shigella,

in order to devise improved vaccine strategies for developing countries.

Activities:

- Molecular epidemiology studies in developing countries

- Basic research on pathogenesis

- Development of improved, computerized information management systems for analysis of genomic information

- Database generation and analysis of genome information on human isolates

- Development of novel vaccine approaches for DNA vaccines

4. Laboratory of Vaccine Development

Donor support: AusAID; Bill & Melinda Gates Foundation; Ministry of Education and Human Resources Development, Republic of

Korea;Sartorius AG; Swedish International Development Cooperation Agency.

Goal: The goals of this laboratory are to develop, improve, and transfer to local producers the manufacturing and quality-control

technologies needed for vaccines against diseases of developing countries.

Activities:

- Development of a subunit Shigella vaccine

- Scaled-up development of a Vi polysaccharide-protein conjugate vaccine against typhoid fever

- Development of improved manufacturing processes for killed, oral cholera vaccine

- Technical assistance in the manufacture of killed, oral cholera vaccine for manufacturers in Vietnam, Indonesia, India, China,

and Pakistan

- Technical assistance in the manufacture of Vi polysaccharide vaccine against typhoid fever for manufacturers in Vietnam,

Indonesia, India, China, and Pakistan

Laboratory Sciences Division

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Training and Technical Assistance Division

Donor support: AusAID; Bill & Melinda Gates Foundation; GlaxoSmithKline; Ministry of Education and Human Resources Development, Republic of Korea; Rockefeller Foundation; Sartorius.Goal: The Training and Technical Assistance Division provides training on modern methods and standards for vaccine production and evaluation, as well as on research methods needed to generate evidence for vaccine policy. As well, the division provides techical assistance to producers in developing countries for the production of new vaccines. The division participates as a trainer in the Global Training Network of the World Health Organization.

Activities (countries participating):

- Training on Good Manufacturing Practices in vaccine production (China, Vietnam)

- Training on production and lot of release testing of killed, oral cholera and Vi polysaccharide vaccines (China, Vietnam,

India, Indonesia, Pakistan)

- Training on Good Clinical Practice standards and methods for trials of vaccines in humans (Bangladesh, Cambodia, China, India, Indonesia,

Pakistan, Philippines, Thailand, Vietnam)

- Post-doctoral training in vaccine sciences (France, Korea, Sweden, United States)

- Annual international course on the principles of vaccinology (Bangladesh, Cambodia, China, Egypt, India, Indonesia, Mozambique, Pakistan,

Philippines, Thailand, Vietnam)

- Workshops on data management methods, microbiological techniques, and social science methods for field studies of vaccines (Bangladesh,

China, India, Indonesia, Mozambique, Pakistan, Thailand, Vietnam)

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Future Directions of the IVI

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Expand program priorities to include additional diseases of importance, such as tuberculosis and emerging respiratory viruses

Extend field research into additional countries of Asia and Africa

Initiate a vaccine evaluation unit in the Clinical Trials Center of Seoul National University

Enlarge the laboratory programs on immunology, molecular microbiology, and chemistry

Create a laboratory of molecular virology to detect and characterize emerging viruses

Establish improved tests for evaluating immunological responses to vaccines in children in developing countries

Develop methods for molecular characterization of known bacterial pathogens under field conditions

Develop new or improved vaccines against Shigella, cholera, and typhoid

Facilitate technology transfer of production of new vaccines to qualified producers

Participate in training in vaccine production and regulation as part of the WHO Global Training Network

Organize periodic courses on the clinical evaluation of vaccines, Good Clinical Practices for vaccine trials, computerized approaches to data

management, and the design and conduct of economic, sociobehavioral, and policy analyses of vaccine introduction

Conduct national and international symposia and workshops on scientific topics of relevance to vaccines for developing countries

1. Translational Research

2. Laboratory Research and Vaccine Development

3. Training and Information Dissemination

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Korea Support CommitteeA large number of prominent Korean citizens have joined together to form the Korea Support Committee for the IVI. The Committee is a vehicle for mobilizing resources within Korea. It is under the leadership of Korea's First Lady, Ms. Kwon,Yang-suk.

Core funding to the IVI is provided by the governments of Korea and Sweden. In addition, donors from the public and the private sector provide support for the Institute's research and technical assistance activities.

AusAID

Bill & Melinda Gates Foundation

Children's Vaccine Program ot PATH

Industry (Aventis Pasteur, Berna Biotech, CJ, Chiron,

GlaxoSmithKline, LG, Merck,Microscience, Nonghyup,

Sartorius, Wyeth)

Japan International Cooperation Agency

Japan Society for the Promotion of Science

Korea International Cooperation Agency (KOICA)

Korea Research Foundation

Korea Research Institute of Bioscience and Biotechnology

Korean Science and Engineering Foundation

Ministry of Education & Human Resource Development,

Republic of Korea

Rockefeller Foundation

Swedish International Development Cooperation Agency

UBS Optimus Foundation

United Nations Development Programme (UNDP)

U.S. National Institutes of Health

Wellcome Trust Labs,HoChiMinh city

Donors to the IVI

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Korea: Catholic University, St. Paul's Hospital and St. Mary's

Hospital; Changwon Fatima Hospital; Chonbuk National

University; Chonbuk Provincial Department of Health; Chonju

Presbyterian Medical Center; Green Cross Reference

Laboratory; Hallym University Medical Center; Hanyang

University Hospital; Inha University Hospital; Cheju National

University Hospital; Jung-Eub Hospital; Korea Research Institute

of Bioscience and Biotechnology; Korea University; Korea Food

and Drug Administration; Korean National Institute of Health;

Kyung Hee University Medical Center; LG Life Sciences;

Namwon Medical Center; Pohang University of Science and

Technology; Pusan National University Hospital; Samkwang

Reference Laboratories; Seoul Clinical Laboratories; Seoul

National University; Samsung Medical Center; Social Security

Research Institute; SoonChunHyang University Hospital; Ulsan

University; Wonkwang University Medical Center; Yonsei

University

Japan: National Institute of Infectious Diseases; Osaka

University; Research Institute for Microbial Diseases, The

Institute of Medical Science, The University of Tokyo.

Indonesia: Bio Farma; Centers for Disease Control; Central

Public Health Laboratory; National Institute of Health Research

and Development; Udayana University; U.S. Naval Medical

Research Unit 2

India: All India Institute of Medical Sciences; Indian Council of

Medical Research; International Center for Genetic Engineering

and Biotechnology; National Institute of Cholera and Enteric

Diseases; Shantha Biotechnics

Germany: Sartorius Group

France: Aventis Pasteur; Epicentre; Institut Pasteur

Finland: National Public Health Institute

Egypt: Ministry of Health and Population; U.S. Naval Medical

Research Unit 3; Vacsera

China: An Hui Province Anti-Epidemic Station; Beijing Friendship

Hospital; Changchun Children's Hospital; Centers for Disease

Control; Dongnan University School of Public Health; Fudan

University; Guangxi Maternal and Child Hospital; Guangxi Medical

University; Guangxi Province Anti-Epidemic Center; Guangxi

Provincial Hospital; Hebei Province Anti-Epidemic Station; Jiangsu

Province Anti-Epidemic Station; Kunming Children's Hospital;

Lanzhou Institute of Biological Products; Lulong County Health

and Anti-Epidemic Center; Ma-An-Shan Hospital; Nanning Second

City Hospital; Sinovac Biotech; Suzhou Medical School; Wuhan

Institute of Biological Products; Wuming County Hospital; Yongning

County Hospital

Canada: Health Canada; University of Western Ontario

Cambodia: Communicable Disease Control, Ministry of Health;

Kantha Bopha Children's Hospital; National Immunization

Program, Ministry of Health; National Pediatric Hospital

Belgium: GlaxoSmithKline Biologicals

Bangladesh: ICDDR,B; Center for Health and Population

Research; Dhaka Shishu Hospital

Australia: The Queensland Institute of Medical Research

International Collaborators

17

Page 19: Ivi brochure 2004

Sweden: Swedish Bacteriological Laboratory; University of

Gothenburg

Sri Lanka: Epidemiology Unit, Ministry of Health; Lady

Ridgeway Hospital

International: World Health Organization

Vietnam: Bach Mai Hospital; Hanoi Health Service; Ha Tay

Province Preventive Medicine Center; HoChiMinh Pasteur

Institute; Hue City Hospital; Hue Province Preventive Medicine

Center; Institute of Vaccines and Biological Substances; Khanh

Hoa Provincial Hospital; National Institute of Hygiene and

Epidemiology; National Institute of Pediatrics; Nha Trang Pasteur

Institute; Ninh Hoa District Hospital; Phu Tho Province Center for

Preventive Medicine; Phu Tho Provincial Hospital; VaBiotech;

Wellcome Trust , Center for Tropical Diseases, HoChiMinh City

United States: Arizona State University; Brandeis University;

California Institute of Technology; Center for Biologics Evaluation

and Research, Food and Drug Administration; Centers for

Disease Control and Prevention; Chiron; Colorado State

University; Harvard University; Johns Hopkins University; Merck;

National Institutes of Health; Naval Medical Research Center;

Portland University; Program for Appropriate Technology in

Health; Purdue University; University of Alabama; University of

California at Berkeley; University of California at Los Angeles;

University of Maryland; University of North Carolina at Chapel Hill;

University of Pennsylvania; University of Rochester Medical

Center; University of Texas Medical Branch at Galveston; Walter

Reed Army Institute of Research; Washington University; Wayne

State University; West Virginia University; Wyeth

United Kingdom: Wellcome Trust Sanger Institute; Health

Protection Agency; Imperial College London; London School of

Hygiene & Tropical Medicine; Microscience; National Institute of

Biological Standards and Control

Thailand: Armed Forces Research Institute of Medical

Sciences; Center for Disease Control, Ministry of Public Health;

Mahidol University

Singapore: K.K. Women's and Children's Hospital

Philippines: Cebu Institute of Medicine; Research Institute for

Tropical Medicine

Pakistan: Aga Khan University; Amson Pharmaceuticals

Mozambique: Ministry of Health

Mongolia: Maternal and Child Health Research Center,

Ministry of Health

Laos: Mahosot Hospital; National Institute of Public Health,

Ministry of Health

18

Switzerland: Berna Biotech; Medecins Sans Frontieres; World

Health Organization