Projects

Research subject

Safety and Immunogenicity of the Malaria Vaccine Candidate BK-SE36/CpG in Healthy Malaria-Exposed African Adults and Children Living in Burkina Faso

Institution

Osaka University Hospital

Principal investigator

Prof. Toshihiro Horii

Contact (email)

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Study outline

The malaria vaccine candidate BK-SE36 is based on a recombinant form of the Plasmodium falciparum serine repeat antigen (SERA). The safety and immunogenicity of BK-SE36 was demonstrated in a phase Ia 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 Northern Uganda.The trial promising results justified the conduct of a phase Ib trial of BK-SE36 in younger cohorts aged from 1 - 5 years old toddlers in Burkina Faso. This on-going trial aims at testing the immune response in younger cohorts that has so far not been included in BK-SE36 malaria vaccine clinical trial, compare clinical trial results from two African countries with different malaria endemicity and generate additional data on safety, immunogenicity and possible preliminary efficacy of BK-SE36.The immune response to BK-SE36 may still be improved with the use of DNA sequences containing CpG motifs that can selectively promote cellular and/or humoral immune responses. A phase Ia clinical trial using BK-SE36/CpG was conducted in healthy adults in Japan where the vaccine was deemed safe and elicited antibody titres were 3- to 4- fold higher as compared to BK-SE36 alone. The proposed clinical trial will assess BK-SE36/CpG safety and immunogenicity in a population exposed to malaria.