The „first-in-man“ study is performed at the Heidelberg University Medical Center, Department of Clinical Pharmacology. In this physician-sponsored phase I clinical trial, the safety and tolerability of two doses of the MSP-1 based subunit vaccine will be tested in 32 healthy volunteers in combination with an adjuvant (Infectious Disease Research Institute, IDRI; Seattle, WA, USA) in a double-blinded, placebo-controlled, randomized manner. In addition to the safety parameters, the induction of an immune response as reported in epidemiological field studies in Africa and in vivo efficacy studies (monkeys, rabbits) will be monitored.
The first volunteers were enrolled in April 2017. The results of the first study are very promising as (i) no adverse events have been observed, (ii) all volunteers sero-converted, and (iii) the anti-Msp-1 directed antibodies are functional in an in vitro assay (see press release).
After successful completion of the first study, Sumaya is planning to initiate its clinical development in Africa. A detailed plan and possible clincial sites are still under discussion. However, the clinical developmen plan in Africa will comprise the following studies:
- a Phase Ib/II study using the optimal dose identified in the German study in Malaria naive and exposed (pathogen-free) individuals followed by controlled challenge with GMP Plasmodium preparations.
- a Phase Ic/II 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 and challenge with GMP Plasmodium preparations.
- a Phase II study using the optimal regimen of the previous studies in a larger cohort.