The International Vaccine Institute is the world’s only international organization created by treaty devoted to research and development of vaccines against diseases affecting developing countries. It is located in Seoul, Korea and is governed by an international board of trustees. The Director General, Dr. John Clemens, is a recognized authority in diarrheal diseases and has also led major studies in respiratory and other infectious diseases. The Institute is located in a dedicated facility of some 80,000 sq. meters on the campus of Seoul National University and has a state-of-the art laboratory where a wide variety of studies are conducted. The Institute is the home of the Pediatric Dengue Vaccine Initiative, a PDP devoted to accelerating the development, evaluation, introduction and delivery of dengue vaccines. The IVI is also the host of PDPs concerned with cholera and typhoid vaccines. It has a staff of more than 150 people and an annual budget exceeding $25 million.
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IVI’s track record in enteric infections and vaccines. Since 2000 IVI has led the Diseases of the Most Impoverished (DOMI) Program and conducted in 7 Asian and African countries and designed to accelerate the development and introduction of vaccines against shigellosis, cholera, and typhoid fever into developing countries. DOMI is a program of translational research; pre-licensure clinical trials; training of developing country professionals on field research, GCP, microbiological diagnosis, clinical immunological assays, and computerized data management; and technology transfer of vaccines to emerging producers. IVI has also successfully conducted field studies on pediatric rotavirus diarrhea and collaborated on the Phase 3 trial of a killed oral ETEC in Egyptian infants and children.
IVI’s track record in coordinating complex, multi-country, public-private partnerships on new vaccines for developing countries. The IVI has successfully coordinated large alliances of vaccine producers, international organizations, academic institutions, government research laboratories, and Ministries of Health in programs to accelerate vaccine development and introduction in developing countries through its DOMI program, the Pediatric Dengue Vaccine Initiative, and, most recently, the Cholera Vaccine Initiative. The IVI has substantial experience in IP management, including in-licensing of IP to facilitate ultimate technology transfer to emerging vaccine producers.
IVI’s in-house technical capabilities in the following areas:
a. Vaccine process and formulation development for bacterial enteric vaccines. IVI’s Vaccine Development group has successfully reformulated and developed in-process controls for a Vietnamese killed oral cholera vaccine in order for the vaccine to meet WHO requirements and has developed scalable formulations of, as well as new in process control and release assays for, vaccines against shigellosis (ribosomal vaccine) and typhoid fever (Vi and Vi-conjugate).
b. Vaccine production technology transfer. IVI is also engaged in transfer of production technology of killed oral cholera vaccine and Vi typhoid vaccine to several emerging producers, including Shantha in India, BioFarma in Indonesia, VaBiotech in Vietnam, and Amson in Pakistan. In these activities, the IVI group not only oversees transfer of production technology and assays, but also participates on-site in hands-on training of producers and works with producers in scale-up activities.
c. Clinical immunology assays. IVI’s Laboratory Research Division has a clinical immunology group devoted to development, standardization, and transfer (to developing country partners) of immunology assays for vaccine evaluation. To date, serological assays for vaccines against cholera and typhoid have been developed and transferred, and work is ongoing on development of serological and ELISPOT assays for the evaluation of Shigella vaccines.
d. Network of field sites and clinical trials capabilities. IVI has conducted field research in 22 countries of Asia, Africa, and Latin America. Many of these sites have investigators who have received GCP training, and several have investigators who have done GCP trials. The IVI has successfully led the design, conduct, and analysis of Phase 2-4 randomized trials and observational studies of live oral, killed oral and parenteral subunit vaccines against cholera and typhoid in 5 developing countries of Asia. These trials have enrolled over 300,000 subjects, and have included trials done under USFDA IND.
e. Translational research. IVI’s Translational Research Division has conducted major programs of interdisciplinary research, data synthesis, and policy analyses on vaccines against cholera, typhoid fever, rotavirus, Japanese encephalitis, Haemophilus influenzae b, and Streptococcus pneumoniae. The work of this unit is conducted by in-house epidemiologists, economists, behavioral scientists, and policy analysts.
f. IVI’s legitimacy as an international organization. 40 countries and the WHO are signatories to the IVI’s constitution. Among them are many developing countries in Asia, Africa, and Latin America. The IVI Board has 4 members from developing countries (China, Indonesia, Mozambique, Vietnam) and two Asian WHO regional directors (SEARO and WPRO). These formal relationships enhance IVI’s ability to launch programs of research and vaccine introduction in developing countries. Also an ex officio member of IVI’s Board is the Executive Secretary of GAVI.
g. IVI’s network of collaborations with vaccine producers in both the industrialized and developing worlds. IVI has a wide network of research and technical assistance collaborations with emerging vaccine producers, biotech companies and multinational pharmaceutical companies including: GSK (Belgium); Lanzhou Institute (China); Sanofi Pasteur (France); Bharat Biologicals, Indian Immunologicals Shantha Biotechnics, and Serum Institute of India (India); BioFarma (Indonesia); Novartis (Italy); Korean Green Cross (Korea); Amson Pharmaceuticals (Pakistan); SBL Vaccins (Sweden); Emergent Europe (UK); Avant, Merck, and Wyeth (US); and IVAC and VaBiotech (Vietnam).