Work package 2 (WP2): Clinical Trial Sponsor, Capacity Building, and Training
Work Package 2 (WP2) is responsible for the clinical trial sponsorship of the ACT-CHIK project. It supports the planning, implementation, oversight, and quality management of the clinical trial while strengthening clinical research capacity across participating African sites. WP2 also works with national regulatory authorities to facilitate future licensure of a safe and effective chikungunya vaccine in Africa.
Objectives
1. To ensure a successful start-up, execution, and completion of the clinical trial, as a clinical trial sponsor
2. Leverage the existing African clinical trial sites network to assess the study sites and prepare the study sites for the ICH-GCP-compliant study conduct
3. Build a regulatory pathway and consultation with the Maturity Level 3 (ML3) National Regulatory Authority (NRA) to license a Chikungunya vaccine in Africa
WP 2 Lead Beneficiary: International Vaccine Institute (IV)
WP 2 Participants: University of Rwanda (UR) & Kenya Medical Research Institute (KEMRI)