Last week, Ifakara Health Institute's SUM-101 clinical trial team conducted a pre-submission meeting with the Tanzania Medicines and Medical Devices Authority (TMDA) in Morogoro. The meeting aimed to align on requirements and expectations ahead of the official submission of clinical trial study protocols and regulatory documents for the SUM-101 study.

Held on April 25, 2025, the meeting marked a significant step in the regulatory engagement process. TMDA officials provided valuable guidance and technical input to ensure compliance with national standards for the upcoming submission. This interaction was pivotal in clarifying key regulatory pathways and strengthening collaboration between Ifakara and TMDA.

Representatives from Ifakara SUM-101 study team included Dr. Maxmillian Mpina, Project Leader, Dr. Aina-Ekisha Kahatano, Lead Clinician, and Hania Msami, Pharmacist.

About the SUM-101 (SumayaVac-1) clinical trial
The SUM-101 (formerly known as SumayaVac-1) clinical trial is a collaborative initiative between Sumaya Biotech GmbH & Co. KG, the European Vaccine Initiative, and the Ifakara Health Institute. 

A Phase I first-in-human, randomized, double-blind trial conducted in Heidelberg, Germany, demonstrated that SUM-101 is safe, with no serious adverse events reported. Subsequently, a Phase Ib study in Bagamoyo, Tanzanian healthy malaria-exposed adults, confirming the vaccine’s safety and good tolerability. Additionally, an age de-escalation, dose-finding Phase Ib study targeting infants and young children is awaiting regulatory approval in Burkina Faso.

To further assess SUM-101’s efficacy, IHI researchers propose using controlled human malaria infection (CHMI) with heterologous blood-stage parasites. These studies will not only accelerate SUM-101’s clinical development but also provide critical data on immune protection against diverse malaria strains, offering valuable insights for optimizing future blood-stage malaria vaccines.

Learn more about the SUM-101 clinical trial here.