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?
- 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.
- 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.
- 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.