IVI and Viet Nam

 

Member State Relations

 

On October 28, 1996, His Excellence Mr. Gô Quang Xuân, Permanent Representative of Viet Nam to the United Nations, signed the Agreement on the Establishment of the International Vaccine Institute.

 

On May 3, 1997, the government of Viet Nam passed Decision No. 289-TTg, ratifying the IVI Establishment Agreement. One month later, On June 3, Viet Nam deposited an instrument of approval with the United Nations.

 

Vietnamese Leadership at IVI

 

From 2004 to 2012, Dr. Ngyuen Tran Hien of Hanoi Medical University served as Viet Nam’s representative on the IVI Board of Trustees.

 

Between 2002 and 2010, Vice Ministers of Health Dr. Trinh Quan Huan and Dr. Nguyen Thi Kim Tiem respectively served on the Board of Counselors and Asia-Pacific Dengue Prevention Board of the Pediatric Dengue Vaccine Initiative (PDVI), an IVI consortium established to lead the accelerated development, evaluation, and introduction of dengue vaccines.

 

Ongoing Collaboration

 

Severe COVID-19 patients in Viet Nam (COVIET)

IVI’s COVIET study in Viet Nam collects clinical and laboratory data from hospitalized COVID-19 patients to estimate the prevalence of secondary infections, compare the clinical outcomes of patients with and without secondary infections, and determine shifts in antimicrobial resistance profiles among major bacterial agents responsible for these infections. A manuscript summarizing findings is prepared, and an analysis is underway on the genomic characterization of the bacterial agent with the highest prevalence of multidrug resistance in secondary infections.

 

As one of the first studies on secondary infections in hospitalized COVID-19 patients in Viet Nam, COVIET is expected to contribute to improved treatment strategies and better clinical outcomes for COVID-19 patients.

 

In Viet Nam, IVI works with the Oxford University Clinical Research Unit and the Hospital for Tropical Diseases, with funding from the Korea Support Committee for IVI.

 

Capturing data on Antimicrobial resistance Patterns and Trends in Use in Regions of Asia (CAPTURA)

The IVI-led CAPTURA project played a pivotal role in expanding historical and current datasets on AMR and antimicrobial usage through extensive data collection efforts across Southeast and South Asia. Building on its successes, CAPTURA II aims to further improve the quality, quantity, analysis, and dissemination of AMR data. This phase focuses on refining methodologies in data collection, stronger monitoring of how surveillance systems are performing, better data management practices, and supporting sustainable improvements in these surveillance systems.

 

The project runs from 2023 through 2025, directly informing national and regional initiatives to help:

  1. Improve AMR surveillance
  2. Promote antimicrobial stewardship
  3. Shape evidence-based policy

 

Countries: Bangladesh, Bhutan, Indonesia, Laos, Nepal, Pakistan, Papua New Guinea, Sri Lanka, Viet Nam

 

Strengthening External Quality Assurance for AMR in Asia (EQAsia)

The Technical University of Denmark is leading a consortium with IVI and the Veterinary Faculty at Chulalongkorn University in Thailand with the Strengthening External Quality Assurance for AMR in Asia (EQAsia) project. During the first phase, the consortium identified and mapped coverage of external quality assurance programs on the continent, providing seven rounds of services and relevant trainings to National Reference Laboratories and Centers of Excellence across One Health sectors. In the next phase, launched in 2023, partners provide four additional rounds of external quality assurance to more than 80 laboratories and centers in Asia and support two countries in establishing national external quality assurance programs to build up their capacity to independently conduct One Health-focused external quality assurance.

 

Regional Antimicrobial resistance Data Analysis for Advocacy, Response and policy (RADAAR)

This initiative improves regional data sharing and analysis for use in AMR planning, policy, and advocacy. The project laid the groundwork to strengthen the capacities of low- and middle-income countries to translate AMR knowledge—from data and evidence to effective policies. In 2024, RADAAR initiated the Evidence-Informed Policy Network with the World Health Organization in Bhutan, hosted a series of policy webinars, initiated online training modules, and conducted a systematic literature review on the economic evaluations of AMR.

 

Countries: Bangladesh, Bhutan, Cambodia, Cameroon, Eswatini, Ghana, Indonesia, Kenya, Laos, Malawi, Nepal, Nigeria, Pakistan, Papua New Guinea, Senegal, Sierra Leone, Tanzania, Timor Leste, Uganda, Viet Nam, Zambia, Zimbabwe

 

Technical Assistance for Clinical Engagement – Asia (TACE Asia)

The TACE Asia project focuses on providing technical support to improve the use of laboratory services and generation of good quality and representative AMR and antimicrobial use data in the human health sector. This will be done through support for clinical engagement and training on the use of simplified protocols to generate AMR burden data in select Fleming Fund priority countries. Launched in 2024, the program is contributing to the use of data on clinical practice and decision-making, improving rational use of antimicrobials, promoting antimicrobial stewardship, and shaping evidence-based practice.

 

Countries: Bangladesh, Bhutan, Indonesia, Laos, Nepal, Pakistan, Papua New Guinea, Sri Lanka, Timor-Leste, Viet Nam

 

Technical Assistance for Data and Evidence Use (TADEU)

The TADEU project was launched to provide technical assistance to support data production and improve the use of AMR data and evidence, with a particular focus on the economic evaluations of AMR.

 

In 2024, the project:

  1. Developed a micro-costing tool to help governments plan future AMR surveillance by informing financial implications, sustainability, and outcomes of AMR surveillance.
  2. Developed protocols and tools to measure the impact of antimicrobial stewardship programs as well as the economic burden of AMR.
  3. Completed literature reviews on existing methodologies and frameworks for econometric modeling and quantifications for AMR economic burden and impact measurements of stewardship programs.
  4. Developed a technical guide for the Political Economy Analysis framework.

 

Countries: Bangladesh, Indonesia, Laos, Nepal, Pakistan, Papua New Guinea, Timor-Leste, Viet Nam

 

Previous Collaboration

 

COVID Vaccine Clinical and Operational Alliance (COCOA)

As part of the COVID Vaccine Clinical and Operational Alliance (COCOA) consortium, IVI led a global Phase III pivotal trial of SKYCovione™, SK bioscience’s COVID-19 vaccine and Korea’s first homegrown vaccine licensed by the Korean Ministry of Food and Drug Safety. The trial demonstrated the vaccine’s strong immunogenicity and safety profiles in more than 4,000 adults. Study sites in Korea were overseen by SK bioscience, while IVI coordinated the trial across five other countries: New Zealand, the Philippines, Thailand, Ukraine, and Viet Nam. An extension of the trial assessed the immune response and safety of a booster dose of GBP510 adjuvanted with GSK’s pandemic adjuvant. This stage enrolled 450 participants from Korea and Thailand. Clinical study reports were released in 2024.

 

Based on clinical results, SKYCovione™ was added to the WHO Emergency Use Listing in 2023, receiving full marketing authorization from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency. It became Korea’s first homegrown vaccine to secure full marketing authorization in the United Kingdom and the 12th COVID-19 vaccine recognized by the WHO.

 

TUNDRA: AMR Research

In November 2017, IVI’s Epidemiology unit initiated its TUNDRA program. TUNDRA, or the Real-time tracking of Neglected Bacterial Diseases and Resistance Patterns in Asia, established and conducted real-time disease surveillance of pathogens in the febrile and respiratory infections from hospitalized children. These hospital-based surveillance operations characterized pathogen resistance patterns phenotypically and genotypically. In Viet Nam, the TUNDRA program operated at the Hospital for Tropical Diseases, Children’s Hospital 1, and Children’s Hospital in Ho Chi Minh City.

 

Cholera Vaccine Development

IVI and VaBiotech formed a product development partnership to produce the world’s first safe, efficacious, and affordable oral cholera vaccine (OCV) for global health. VaBiotech’s ORC-VaxTM vaccine was proven safe and effective in the Vietnamese population but was not formally certified by the WHO for global distribution. To ensure the vaccine met international Good Manufacturing Practice (GMP) standards and WHO global production guidelines, IVI and VaBiotech developed a reformulated vaccine with a higher yield, lower production costs, and a more affordable price. The reformulated low-cost vaccine was tested in clinical trials in both Viet Nam and India and was demonstrated to be safe and more effective than the earlier version of ORC-Vax. To ensure the reformulated vaccine could be made available internationally, IVI facilitated a technology transfer between VaBiotech and Shantha Biotechnics Ltd. of India. In 2009, the vaccine was licensed in both Viet Nam (mORCVAXTM) and India (Shanchol), and in 2011, Shanchol was approved by the WHO Prequalification Program, making it the first affordable OCV ($1.85 per dose) available for the global public market.

 

DPRK Assistance

From 2007 to 2013, IVI worked in the Democratic People’s Republic of Korea (DPRK) to improve its capacity for preventing and controlling infectious diseases. Viet Nam played a critical role in this program, with the NIHE hosting 11 North Korean scientists in Hanoi in 2009 and 2010 for laboratory training and a training workshop. The training equipped these scientists with the knowledge and skills necessary to train their peers in the DPRK.

 

Japanese Encephalitis

From 2000 to 2010, IVI worked with the National Institute of Hygiene and Epidemiology (NIHE) to combat Japanese Encephalitis in Viet Nam. A primary component of this work was conducting disease burden, cost-of-illness, and cost of vaccination studies. In addition, IVI conducted a mass vaccination campaign from 2004 to 2006 in Ha Tay province using VaBiotech’s locally produced JE vaccine. IVI trained 800 public-health workers in preparation for the vaccination campaign, and over 62,000 children aged 1-10 received the vaccine. The vaccination campaign proved the feasibility, acceptability, and cost-effectiveness of JE vaccination with the locally produced JE vaccine.

 

DOMI: Typhoid

From 2001-2006, IVI carried out a typhoid vaccination campaign in Hue as part of its Diseases of the Most Impoverished (DOMI) program. Working with local investigators, over 32,000 school-aged children in Hue received the Vi-PS typhoid vaccine. As part of the vaccination effort, IVI conducted a nationwide disease burden surveillance study. Analyses of the study concluded that typhoid vaccination of school-age children in high-risk provinces in Viet Nam can substantially reduce the burden of typhoid fever with no extra costs to the government if cross-subsidization schemes are used. These analyses were presented at an international meeting on DOMI in Hanoi in 2005. As a result, in 2006 the government of Viet Nam decided to support a pilot project of a financially sustainable Vi PS immunization program in Dien Bien province, which had the country’s highest typhoid incidence rates.

 

DOMI: Shigella

From 2002-2005, IVI investigated shigella in Hue as part of its DOMI program. IVI’s disease burden studies, cost of illness studies, and public surveys showed that shigellosis imposes a heavy economic burden on both public-sector institutions and private households, which considered Shigella as a high-risk threat to their children. The studies found that there would be a uniformly high demand for a vaccine against shigella for children. While a vaccine does not yet exist, IVI is developing an affordable Shigella vaccine.

 

Rotavirus

Between 2000 and 2009, IVI conducted a number of activities combating the diarrhea-causing rotavirus across Viet Nam. IVI conducted hospital-based studies in Viet Nam to determine the incidence rates of intussusception, a side-effect of the first rotavirus vaccine, RotaShield. IVI discovered 114 cases of intussusception in Vietnamese children, adding impetus to the need for a safe rotavirus vaccine. To that end, in 2006 and 2007 IVI assisted the NIHE with clinical trials for two new rotavirus vaccines- RotaRix and Rotateq, in Khan Hoa and Nha Trang. In 2009, IVI and the NIHE completed a one-year surveillance study in Khanh Hoa, Vinh Phuc, and Hai Phong to determine the rotavirus diarrhea incidence rate in children under 5. Results indicated 1 out of 5 children seeking treatment for gastroenteritis had rotavirus.  Economic data were used to estimate the cost-of-illness from both rotavirus and other diarrheas incurred by the public sector and by families. The results were used alongside RotaTeq vaccine efficacy data to calculate the vaccine’s cost effectiveness in Viet Nam.

 

Technical Assistance and Training

In Nha Trang, the NIHE hosted one of IVI’s first training programs, the 2001 First International Course on Vaccine Evaluation in Developing Countries. This program later evolved into IVI’s annual Vaccinology Course, in which Over 60 Vietnamese health professionals have received training.

 

In 2002, IVI helped Viet Nam establish a large, linked database for recording, tracking, and evaluating potential vaccine adverse events. Headquartered in Nha Trang, the database allows Vietnamese health professionals to share and review medical records describing vaccinations and medical events and identify potential adverse effects. The successful creation of this database in Viet Nam led IVI to develop the Vaccine Adverse Events Information Management System (VAIEMS) as part of the WHO’s Global Vaccine Safety Initiative (GVSI). The VAIEMS database system is now used in health programs around the world.

 

From 2010 to 2011, IVI worked with the government of Viet Nam to strengthen its existing National Immunization Technical Advisory Groups (NITAGs) by providing training and technical assistance. Capacity-building initiatives included sending delegates from Viet Nam’s NITAGs to Australia where they received training and consultations from the Australian Technical Advisory Group on Immunization.

 

Respiratory Bacterial Disease Research

From 1999 to 2011, IVI worked with the NIHE to conduct a number of disease burden studies on Haemophilus influenza (Hib), Streptococcus pneumoniae and Neisseria meningitides in Hanoi and Nha Trang.  The results of these studies were provided to Vietnamese policymakers to inform their decision on introducing Hib conjugate vaccine in the national immunization schedule, helped the NIHE understand the spread of seasonal and pandemic influenza viruses, and led to the development of enhanced public health control measures in Viet Nam.

 

Dengue

From 2008 to 2015, PDVI and the subsequent Dengue Vaccine Initiative (DVI) carried out a number of projects to determine the impact of dengue fever in Viet Nam, from funding a dengue fever surveillance study among children in My Tho, to cost of illness and willingness to pay for vaccines studies in Nha Trang.

 

DVI also provided technical support to Vabiotech with the development of their dengue vaccine candidate, specifically in process development, regulatory guidance, and capacity-building in clinical trials.