The IMVACS Consortium has assembled a Trial Steering Committee (TSC) to provide critical oversight for the planning, implementation, and monitoring of the study.
TSC plays a central role in ensuring that the trial adheres to Good Clinical Practice and relevant regulatory standards, while addressing any emerging scientific, operational, or health-related issues that could impact the study’s protocol, participant safety, or data integrity.
A core responsibility of the TSC is to assess and recommend changes to the trial protocol, when necessary, particularly in response to safety concerns or opportunities to strengthen the scientific rigor of the study. The committee has the authority to make decisions regarding protocol deviations or amendments, especially in response to evolving data, adverse events, or interim analysis findings. Additionally, the TSC ensures that comprehensive risk management strategies are in place, preserving the trial scientific validity while minimizing risks to participants.
In addition to their oversight of the trial technical and operational execution, the TSC serves as a decision-making body for resolving conflicts, addressing stakeholder concerns, and ensuring consensus is achieved across all involved teams.
The committee also monitors the progress of the trial, ensuring that it stays on track to meet established timelines and the highest quality standards.
Upon the trial completion, the TSC is responsible for overseeing the proper dissemination of results, ensuring transparency, and maximizing the impact of the findings on public health policies.
The TSC consists of the following members:
- Dr. Natama Magloire – IMVACS Scientific Coordinator, WP3 Leader
- Dr. Dario Scaramuzzi – IMVACS Financial Coordinator, WP1, WP2, WP8 Leader
- Prof. Kassoum Kayentao – WP4 Leader
- Dr. Elisabeth Baudin – WP5 Leader
- Dr. Jenny Hill – WP6 Leader (Socio-sciences)
- Prof. Eve Worral – WP6 Leader (Health economics)
- Dr. Mamadou Ouattara – WP7 Leader
- Dr. Lise-Anne Denoeud – Sponsor Representative (WP9)
- Dr. Saschveen Singh – Médecins Sans Frontières (France), Independent Member
- Dr. Matthew Coldiron – Médecins Sans Frontières (UK), Independent Member
- Prof. Mahamadou Thera – University of Sciences, Techniques and Technologies of Bamako, Mali (USTTB), Independent Member
With their extensive expertise in malaria research, vaccination strategies, public health, and ethics, the TSC ensures a comprehensive and integrated approach to the IMVACS study. Their leadership is essential in guiding the study toward successful outcomes, ultimately shaping malaria vaccination strategies in Burkina Faso, Mali, and beyond.
