SAFLI-R21-10 is an ancillary study conducted within the broader IMVACS project, operating under a stand-alone protocol independent of the main IMVACS study. The Principal Investigator for this ancillary study is Professor Kassoum Kayentao from the University of Sciences, Techniques and Technologies of Bamako (USTTB).
The study aims to compare the safety, reactogenicity, and humoral immunogenicity of the 10-dose formulation of the R21/Matrix-M vaccine with the 2-Phenoxyethanol (2-PE) preservative with those of the standard 2-dose R21/Matrix-M formulation.
The study is being conducted in the DioĂŻla Health District, Mali, and involves 100 children, equally distributed between a control arm and an intervention arm.
đź“Ť Study progress to date
Control arm – Wacoro (pre-SMC vaccination):
As of 18th July, the first two doses out of three of the 10-dose R21/Matrix-M formulation with 2-PE have been successfully administered:
- First dose: 13th–15th June 2025
- Second dose: 11th–13th July 2025
- The third dose is planned four weeks after the second dose.
Intervention Arm – Kola (aligned with SMC rounds)
So far, only the first of the three doses of the 10-dose formulation with 2-PE has been administered on July 17th, 2025, during the first round of SMC. The subsequent doses are scheduled for August and September, coinciding with the second and third rounds of SMC.
