EVI begins clinical trial for promising malaria vaccine in Burkina Faso
- EVI
- Aug 14
- 4 min read
Updated: Oct 8
European Vaccine Initiative (EVI) announced today the launch of clinical trial in Burkina Faso to evaluate full-length MSP1, a promising, new malaria vaccine candidate. The start of the trial marks a major milestone in EVI´s mission to accelerate the development of effective and accessible vaccines.
14 August 2025
The Phase I/IIa clinical trial (NCT06618885) will evaluate the safety and immunogenicity of full-length MSP1/GLA-SE (SUM101), a promising new liver and blood-stage malaria vaccine candidate, in healthy infants and children in Burkina Faso. The vaccine aims to boost immune protection against Plasmodium falciparum, the most lethal malaria parasite, which continues to claim over 600 000 lives each year, the majority of them children under the age of five, in sub-Saharan Africa.
The study is the result of a close collaboration between the Groupe de Recherche Action en Santé (GRAS) in Ouagadougou, Burkina Faso – a leading clinical trial institution in West Africa; Sumaya Biotech GmbH & Co. KG, a German company developing the MSP-1 full-length vaccine; the Access to Advanced Health Institute (AAHI), the inventor, owner, and vendor of the adjuvant formulation and EVI, a non-profit product development partnership and sponsor of the clinical trial. If successful, the results will support further development of the vaccine and help position it as a valuable addition to the toolbox of interventions for malaria prevention.
“This EVI-sponsored clinical trial of a promising new vaccine candidate reflects our commitment to innovation in malaria vaccine development and our strong longterm partnerships with GRAS and Sumaya”, said EVI’s Executive Director, Dr. Ole F. Olesen, “it also marks EVI’s growth from a support and coordination role to direct involvement in clinical trial sponsorship.”
Professor Sodiomon Bienvenu Sirima, the Principal Investigator leading the research team and CEO of GRAS sated: “This vaccine trial is a landmark for the clinical development of this promising vaccine candidate. It is a stepping stone of a vaccine positioned to potentially alleviate the burden for our kids who are still dying from malaria despite the enormous progress these recent years”.
Dominique Doyen, CEO of Sumaya Biotech said: “After the encouraging results obtained for the vaccination of healthy adults, we are excited to support this first clinical trial in children with our full-length MSP1 vaccine. We strongly believe in its significant potential to protect in particular young children in sub-Saharan Africa from this deadly disease. EVI and its network have a strong track record in strategic partnership and clinical trial management. We are grateful entering such collaboration with EVI and looking forward to the initiation of such study in children in the near future”.
Moreover, Dr. Souyet Chang-Rodriguez, EVI’s Senior Clinical Project Manager, leading the coordination of the trial stated: “As the sponsor of this trial, we ensure the study is both ethically conducted and scientifically rigorous. Most importantly, we take full responsibility for the safety of participants and the integrity of the data generated”.
By conducting this trial, GRAS, Sumaya Biotech and EVI, working in close collaboration, will strengthen the capacity of African researchers, laboratories, and health systems to the benefit malaria and public health research more broadly. It allows us to advocate for equitable access, to ensure that the solutions we develop are affordable, available, and appropriate for the people who need them most.
For more information about the study, visit: https://clinicaltrials.gov/study/NCT06618885
This trial is part of a project under the EDCTP2 Programme supported by the European Union (RIA2018SV-2310 - MIMVaC-Africa) and co-funded by EVI with funding from The German Federal Ministry of Education and Research (BMBF) through KfW.
About EVI
The European Vaccine Initiative (EVI) is a non-profit Product Development Partnership (PDP) that leads and supports the development of safe, effective and affordable vaccines to address global health needs. EVI works in partnership with research institutions, industry, funders, policy and decision makers, and other key stakeholders to accelerate vaccine innovation. Through its commitment to cutting edge research and strategic partnership, EVI advances a diverse vaccine portfolio and promotes R&D targeting critical public health challenges and emerging opportunities.
About Sumaya Biotech GmbH & Co. KG
Sumaya, a clinical-stage company established in 2014 as a spin-out of Heidelberg University, focussing on combating malaria, one of the world's most urgent health challenges. Headquartered in Heidelberg, Germany, Sumaya’s mission is to develop groundbreaking malaria vaccines and treatments against severe malaria capable of transforming millions of lives. Sumaya is privately owned and received a loan from EU Malaria Fund to support its clinical development pipeline, foremost the Sumaya´s full-length MSP vaccine candidate (SUM-101).
About GRAS
The Groupe de recherche action en santé (GRAS) is a research institute established in 2008 in Burkina Faso, West Africa. It mission is to contribute through innovative health research to harnessing policymakers with the most needed critical knowledge, for an evidence-based decision-making.
Learn more about GRAS at https://gras.bf/
About the full-length MSP1/GLA-SE vaccine candidate (SUM101)
Formulated with the adjuvant GLA-SE, the full-length MSP1 protein presents a novel and innovative malaria vaccine approach, by targeting both the asymptomatic liver stage and the disease-causing blood stages of the human malaria parasite Plasmodium falciparum (P. falciparum).
SUM-101 has demonstrated safety and immunogenicity in two phase I trials involving naïve adult volunteers in Germany and malaria pre-exposed adult individuals in Tanzania confirming both its safety and broad immunogenicity.
About the MIMVaC-Africa consortium
The MIMVaC Africa constituted in total of ten partner institutions from the world, resolutely committed to the fight against malaria through the development of malaria vaccines.
Learn more about MIMVAC Africa consortium at :https://www.mimvac-africa.org/
This project is part of the EDCTP2 Programme supported by the European Union (RIA2018SV-2310- MIMVaC-Africa).
Images: UN Photo/Ismail Taxta (Flickr.com); sheenaboo_99 (Flickr.com).
