at a glance
Malaria | Blood stage
01 November 2016- 31 December 2020
European Vaccine Initiative
GHIT Fund and Nobelpharma
3 Mio Euro
Safety evaluation of BK-SE36/CpG in the malaria endemic population
The Plasmodium falciparum serine repeat antigen-5 (SERA-5) is a blood stage antigen that plays an essential role in the parasite life cycle. The SEmalvac project aims at continuing the clinical development of the recombinant form of the N-terminal domain of the SERA-5 adsorbed on aluminium hydroxide gel (BK-SE36) as malaria blood-stage vaccine for young children living in malaria endemic area.
In pre-clinical model, the immune response is improved when BK-SE36 is formulated with a TLR 9 ligand consisting of CpG motifs that can selectively promote cellular and/or humoral immune responses. The BK-SE36 vaccine formulated with CpC adjuvant (BK-SE36/CpG) was found safe in a phase Ia clinical trial in healthy adults in Japan and elicited antibody titres 3-4-fold higher than BK-SE36 vaccine alone.
In the SEmalvac2 project, launched in parallel to the SEmalvac project, the safety and immunogenicity of the BK-SE36/CpG vaccine will be assessed in healthy malaria exposed adults and children living in Burkina Faso. In this phase Ib age-deescalating trial, the BK-SE36/CpG vaccine safety will be assessed first in adults aged 21-45 years before proceeding to the evaluation of the vaccine in younger populations: children aged 5-10 years and 12-24 months.
European Vaccine Initiative (EVI) (Germany); Institut de Recherche en Sciences de la Santé (IRSS) (Burkina Faso); Medical Center for Translational Research (MTR), Osaka University Hospital (Japan); Nobelpharma Co., Ltd. (Japan); Research Institute for Microbial Diseases (RIMD), Osaka University (Japan).