The „first-in-man“ study was completed at the Heidelberg University Medical Center, Department of Clinical Pharmacology in 2019. MSP1 was safe, well tolerated and immunogenic, with all vaccinees sero-converting independent of the dose. (See press release)
Sumaya is about to initiate a Phase Ib trial. The overall clinical development plan in Africa will comprise the following studies:
- a Phase Ib study using the optimal dose identified in the Phase Ia study in Malaria semi-immune (or malaria-experienced/exposed) (pathogen-free) individuals followed by controlled human malaria infection (CHMI) challenge with GMP Plasmodium sporozoites preparations.
- a Phase Ic study „priming“ Malaria naive and exposed (pathogen-free) individuals with an Adenoviral vector expressing the MSP-1 protein followed by the MSP-1/adjuvant combination boost and subsequent challenge with GMP Plasmodium sporozoites preparations.
- a Phase II study using the optimal regimen of the previous studies in a larger cohort.