BK-SE36

SEmalvac

at a glance

TARGET DISEASE

TIMELINE

COORDINATOR

FUNDER

FUNDING

Malaria | Blood stage

01 August 2014- 31 July 2020

European Vaccine Initiative

GHIT Fund and Nobelpharma

2.3 Mio Euro

SUMMARY

Clinical development of the BK-SE36 malaria vaccine candidate

The SEmalvac project aims at advancing the clinical development of the Plasmodium falciparum serine repeat antigen-5 (SERA5), a blood-stage malaria vaccine. SERA5 is indispensable during blood-stage growth, is suggested to be involved in parasite egress and in parasite immune evasion. SERA5 may likely overcome two major challenges for malaria vaccine antigens as it shows limited polymorphism and has immunodominant IgG epitopes that do not require strict tertiary structures to elicit protective antibodies. A recombinant form of SERA5 N-terminal domain (SE36) was prepared and formulated with aluminium hydroxide gel to yield BK-SE36 vaccine. The safety and immunogenicity of BK-SE36 was demonstrated in a phase Ia clinical trial in malaria naive Japanese adults, and in a phase Ib trial conducted in healthy subjects aged 6–32 years from a malaria endemic area in Uganda.
The main objective of the project is to assess the safety and immunogenicity of BK-36 vaccine in a younger (1-5 years) healthy population living in malaria endemic region of Burkina Faso.

PARTNERS

Centre National de Recherche et de Formation sur le Paludisme (CNRFP) (Burkina Faso); European Vaccine Initiative (EVI) (Germany); Research Institute for Microbial Diseases (RIMD), Osaka University (Japan).

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