IVI and Guatemala
Ongoing Collaboration
IVI’s Global Chikungunya vaccine Clinical Development Program (GCCDP) was initiated in June 2020 in partnership with Bharat Biotech in India to advance Bharat’s chikungunya vaccine candidate with the ultimate goal of achieving WHO prequalification and emergency use listing. This program involves a Phase II/III randomized, controlled vaccine clinical trial with an adaptive and seamless design to evaluate the safety and immunogenicity of a two-dose regimen of BBV87 chikungunya vaccine in healthy subjects aged 12-65 years in five countries across Asia and Latin America, including Colombia, Costa Rica, Guatemala, Panama, and Thailand. These studies are running in parallel to Bharat Biotech’s clinical trials in India as part of the global clinical development plan of BBV87 vaccine.
From November 2022 to February 2023, the team finalized data sets for Parts A and B of the study. Subsequently, the third Data and Safety Monitoring Board meeting concluded in May 2023 with no identified safety issues. The optimal dose for Part C has been selected and supported by the immunogenicity and safety data and results of the non-human primate study. Beginning 2024, recruitment for Part C will be initiated and consultations with WHO entities, NRAs, and National Immunization Technical Advisory Groups (NITAGs) will continue.
In December 2023, IVI convened the first Chikungunya Global Stakeholder Meeting in Panama in partnership with Gorgas Institute, bringing together stakeholders across government, research and development, and industry to map a comprehensive landscape of the problem of chikungunya and to advocate for the recognition, approval, and support of a global chikungunya vaccine agenda.
In Guatemala, the GCCDP project is conducted in collaboration with the Centro De Estudios Clinicos Salud Avanzada (CECLISA).