Despite being preventable and curable, malaria continues to pose a significant burden in tropical and subtropical regions. This life-threatening disease is transmitted to humans by specific types of mosquitoes, placing nearly half of the world's population at risk. The gravity of the situation is underscored by the fact that in 2021 alone, an estimated 247 million people were afflicted by malaria across 84 countries resulting in 619’000 deaths.
The SumayaVac-1 study is a Phase Ib clinical trial for a new malaria vaccine, SumayaVac-1 (SUM-101), a collaborative effort between Sumaya Biotech GmbH & Co. KG, Swiss TPH, and the Ifakara Health Institute. This study involves healthy African adult volunteers who have been pre-exposed to malaria in Bagamoyo, Tanzania.
Its objectives are to assess the vaccine's safety and its ability to generate an immune response against the malaria parasite. Forty participants split into two groups receive three doses, approximately one month apart, of either the SUM-101 vaccine or a comparator (rabies vaccine). The SUM-101 vaccine is composed of the full length merozoite surface protein (MSP-1) expressed on merozoites and during the liver stage + a potent immune-stimulatory adjuvant called GLA-SE (Glucopyranosyl Lipid A Adjuvant-Stable Emulsion). The vaccine simultaneously targets the two crucial stages of the parasite’s infectious cycle, the liver and the blood stage.
The study duration for participants is 20 weeks (5 months). Initiated in August 2023, the study is expected to conclude in April 2024, with initial results anticipated at the end of 2024.
Status of the Study and Milestones Ahead
Currently, all 40 volunteer participants were enrolled in the study. Group 1 (n = 20) participants received all 3 vaccinations, and group 2 (n= 20) participants received the 1rst and the 2nd vaccination. All participants will have completed the vaccinations by the beginning of January 2024. Follow-up visits will be conducted at 4 and 5 months after the first vaccination to monitor the safety parameters in the participants and collect samples to measure the immune response.
The SumayaVac-1 study was conceived after completion of the Phase 1a study in Heidelberg, Germany showed promising results in malaria-naïve adult Caucasian volunteers. The current study investigates if the immune responses in pre-exposed participants living in a malaria endemic country would be strong enough to contribute to the immunological defense of a malaria infection.
After completion of the study, samples will be analyzed in laboratories at Ifakara Health Institute, Swiss TPH and the University of Heidelberg. A report of the final study results is expected to be completed by the end of 2024.
Relevance of the Study
If the SumayaVac-1 (SUM-101) vaccine is proven safe and in later studies effective, a new vaccine could help protect millions of children and adults from getting a malaria infection, especially in malaria endemic countries such as those in sub-Saharan Africa.
RTS,S and R21 are both first generation malaria vaccines targeting the circumsporozoite protein. While these vaccines have the potential to reduce morbidity and mortality, a higher vaccine efficacy would be desirable. Next generation malaria vaccines might be a combination of two or more protein components derived from different malaria developmental stages that ultimately would result in a higher protection against malaria disease and death.
Full length MSP-1 has never been tested before in malaria pre-exposed populations and the outcome will guide if this MSP-1 protein could become a component of such a next generation malaria vaccine.
Swiss TPH - Swiss TPH is the sponsor of the study. The Clinical Trial Operations Unit (COU) within the Department of Medicine at Swiss TPH is responsible for the operational management of the study and Prof. Dr. Claudia Daubenberger from the Clinical Immunology Unit (CI) of the Medical Parasitology and Infection Biology Department (MPI) is the scientific lead and sponsor representative.
Sumaya Biotech GmbH & Co. KG - A clinical stage biotech company and the industrial sponsor, Sumaya Biotech provided the funding for the clinical trial, supported by the EU Malaria Fund (EUMF). Sumaya, located in Heidelberg, is focused on developing preventive and therapeutic interventions to fight malaria based on the research of Professor Dr. Hermann Bujard and Prof. Michael Lanzer, both associated with the University of Heidelberg. Sumaya developed the MSP-1 component of the vaccine.
Access to Advanced Health Initiative (AAHI) - AAHI is a non-profit biotech research institute focused on creating accessible health solutions for underserved communities around the world. AAHI developed the adjuvant (GLA-SE) used in the vaccine.
Ifakara Health Institute (IHI) - IHI, a leading African health research institute, conducts diverse biomedical, environmental studies, drug/vaccine trials, health-systems research, and monitoring and evaluation. Bagamoyo Clinical Trial Facility is the clinic site performing the clinical trial with Dr. Ally Olotu as the study principal investigator.