Launch of a new malaria vaccine trial brings renewed hope for improved protection

LIH to contribute to study in Africa with its global clinical trial expertise

• Department of Medical Informatics
• Competence Centre for Methodology and Statistics
• Research Projects & Clinical Trials

A new clinical trial for the malaria vaccine candidate SUM-101 has officially launched under the EDCTP2-funded MIMVAC-Africa project. The study, conducted with the crucial expertise of the Competence Centre for Methodology and Statistics (CCMS) at the LIH, seeks to address the urgent global need for more effective and longer-lasting protection against malaria. Trials in Burkina Faso and Tanzania will evaluate safety, immune responses, and preliminary efficacy in children, infants, and adults living in malaria-endemic regions.

Malaria continues to pose a devastating threat to global health, with an estimated 249 million infections and over 600,000 deaths recorded worldwide in 2022. Tragically, children under the age of five account for 76% of these fatalities, underscoring the urgent need for improved preventive measures.

While two malaria vaccines targeting the life cycle of the Plasmodium falciparum parasite are currently licensed, their moderate efficacy and shorter-lasting protection highlight the limitations of existing tools. To overcome these challenges, a new vaccine candidate, SUM-101, is now entering clinical evaluation as part of the MIMVAC-Africa project (A multilateral initiative to foster the clinical development of effective malaria vaccine candidates in Africa).

The trial is being conducted in two malaria-endemic countries, Burkina Faso and Tanzania. In Burkina Faso, researchers are focusing on children and infants. The study begins with a group of children aged 18 months to five years who receive three doses of SUM-101 to confirm safety before moving to younger participants. Once safety is established, infants between five and seventeen months will take part in a randomised, double-blind study comparing SUM-101 with a control vaccine. In Tanzania, the trial involves adults exposed to malaria who will undergo a controlled human infection to test the vaccine’s preliminary efficacy. Researchers will measure the time it takes from infection to diagnosis and treatment, while closely monitoring vaccine safety and tolerability over the 29-week study period.

Throughout this ambitious project, the Competence Centre for Methodology and Statistics (CCMS) of the LIH Department of Medical Informatics is at the very heart of operations. With its longstanding expertise in randomised clinical trials, the CCMS provides essential support that ensures the scientific rigor and reliability of the study. Its Clinical Data Management team is responsible for handling the vast amount of trial data with accuracy and security. The Biostatistics team designs and oversees the randomisation process, which is critical to ensuring unbiased results. Finally, the Methodologists team conducts the analyses that will determine the vaccine’s performance and significance. Without these coordinated efforts, the integrity of the trial would not be possible.

If SUM-101 proves successful, the research will open the way for larger Phase II
and III studies. For the communities most affected by malaria, this represents
the hope of a new generation of vaccines that could offer stronger and
longer-lasting protection, and for global health, it marks an important step
toward reducing the enormous burden of one of humanity’s oldest diseases.

says Dr Michel Vaillant, Head of CCMS.

Funding and collaborations

The MIMVAC-Africa project is coordinated by GRAS (Groupe de Recherche Action en Santé) in Burkina Faso and is carried out in collaboration with EVI (European Vaccine Initiative). It is funded by the European & Developing Countries Clinical Trials Partnership (EDCTP2) and the Luxembourg National Research Fund (FNR).