Work Package 3 (WP3): Clinical Trial Conduct in Africa
Work Package 3 (WP3): Clinical Trial Conduct in Africa is responsible for the implementation and coordination of the ACT-CHIK Phase Ib/III clinical trial across multiple African countries. The work package ensures that the study is conducted according to international ethical, scientific, and regulatory standards while generating robust evidence on the safety and immunogenicity of the MV-CHIK vaccine in diverse African populations.
Why WP3 Matters:
Clinical trials are essential for determining whether new vaccines are safe and effective. WP3 plays a central role in evaluating the MV-CHIK vaccine under real-world African settings, ensuring that the evidence generated reflects the populations most affected by chikungunya.
Objectives
1. To coordinate as a coordinating PI (CPI) with the study principal investigators, conduct a Phase Ib/III, multicenter, multi-country, observer-blinded, age-descending, randomized, active-controlled trial to assess the immunogenicity and safety of the MV-CHIK vaccine among adults, adolescents, and children living in Africa.
2. To evaluate the safety and tolerability of MV-CHIK administered in one or two doses on a 0-28 day schedule.
3. To assess the immunogenicity in terms of functional anti-CHIKV antibodies of MV-CHIK at 28 days post-dose 2, administered on a 0-28 day schedule.
Work Package 3 Lead Beneficiary: Irrua Specialist Teaching Hospital (IRRUA)
Work Package 3 Participants: University of Rwanda (UR), Institut Pasteur de Dakar (IPD) and Kenya Medical Research Institute (KEMRI)