Nepal is a signatory of the IVI Establishment Agreement, helping to found IVI as an international organization. Since then, we’ve worked with the Nepalese government, universities, and research organizations on vaccine R&D collaborations and vaccination campaigns to prevent, control, and end the spread of infectious diseases such as typhoid and cholera.

In March 2021, IVI and the Nepal Health Research Council signed a Memorandum of Understanding during a virtual ceremony, laying the foundation for the two organizations to build research capacity in Nepal and work together to improve public health in the region.

Building research capacity locally to strengthen health systems globally

Studies suggest that the global typhoid burden ranges from 12 to 21 million cases every year, causing up to 145,000 deaths worldwide. This burden is particularly high in low- and middle-income countries in Asia and sub-Saharan Africa.

In order to develop research capacity in the resource-limited settings where typhoid fever burden is highest, IVI elected to conduct a Phase III clinical trial of its novel typhoid conjugate vaccine—Vi-DT— in Nepal, where typhoid is endemic and where few late-stage clinical trials are conducted. Learn more about what made this clinical trial a challenge but a valuable learning for the future, and why it’s vital to enable more research in the places where people live with the burden of vaccine-preventable, poverty-associated diseases.

Read more: Challenges and opportunities in setting up a phase III vaccine clinical trial in resource limited settings: Experience from Nepal

Reflections on conducting a late-stage vaccine clinical trial in Nepal

with Dr. Tarun Saluja, Research Scientist at IVI and Project Lead of the Vi-DT typhoid conjugate vaccine study in Nepal

Why was Nepal an opportune country for late-stage clinical trials of Vi-DT?

Nepal is a low-income country with high endemicity of typhoid. As one of the mandates of IVI to build the research capacity in developing countries, Vi-DT Phase III clinical trial provided a crucial opportunity to both tap the enormous potential and cultivate a robust research culture (developing research capacity) in Nepal. Several LMICs were evaluated and Nepal was chosen in close consultation with the Bill & Melinda Gates Foundation and the vaccine manufacturer, SK bioscience.

How does increasing clinical research in low- and middle-income countries contribute to stronger and more equitable global health?

The Global Forum for Health Research report emphasizes that strengthening research capacity in developing countries is one of the most effective and sustainable ways of advancing health and development in these countries, as well as helping correct the gap in health research and contribute to overall global health.

Can you share 3 key takeaways from preparing for this Phase III study that would help inform future clinical research in resource-limited settings?

1. Being new to clinical trials, the sites had many weaknesses which were addressed through extensive planning, preparation, and training. Therefore, a robust training matrix needs to be put in place and capacity building should be part of each and every planned research in LMICs and resources should be allocated accordingly.
2. The institutional ethical committees at the sites were at various levels of experience, and the strengthening of site ethical review could contribute further to the enhancement of site research capacity.
3. The young generation of researchers are eager to be part of quality research studies and international research organizations like IVI could provide the right platform to gain experience and expertise.

What’s the next step for this new typhoid vaccine?

To achieve local licensure of the vaccine in the country of manufacture (South Korea for the vaccine manufactured by SK bioscience) followed by World Health Organization (WHO) pre-qualification (PQ) which is pivotal to be eligible for purchase by United Nations agencies like UNICEF or Gavi, the Vaccine Alliance.