The Bill and Melinda Gates Foundation has granted the International Vaccine Institute (IVI) $15.7m to support the late-stage development of a typhoid conjugate vaccine for public sector markets.
According to IVI, an international non-profit organization, the grant will fund Phase III trials of the Vi-DT typhoid conjugate vaccine (TCV). Clinical trials are scheduled to take place in Nepal and the Philippines over the next two years.
IVI developed the vaccine and transferred the technology to its Korean partner, SK bioscience, which has completed process development and scale-up activities.
To date, the Phase I study has been successfully completed, and a Phase II study is underway.
Selecting study sites
According to Dr. Anh Wartel, head of clinical development and regulatory, IVI, “One of the challenges for clinical research in low- and middle-income countries is to select the study sites capable of conducting the study as per the international standards.”
Before starting any study, the organization assesses feasibility and site capability in the identified country based on the international requirements, Wartel told us. “Risks and challenges can thus be identified, and a mitigation plan is accordingly developed ahead of the study start,” she added.
For example, “infrastructure development as per the study requirement and a robust training program including good clinical practice training for each study site members will be put in place,” explained Wartel.
The study sites also will be monitored regularly by the qualified study staff from IVI to ensure the study meets international standards.