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.
  • Area of the study
    Other than cancer
    Development items
    Drugs
    Regulatory approval
    Unapproved
    Main country where studies are conducted
    Led by a country abroad
    Leading country name:(Burkina Faso)
    Number of participating countries, Number of participating institutions
    Number of participating countries:1, Number of participating institutions:1
    Participating countries' names
    Burkina Faso
    Study design
    Interventional study
    Development phase
    Phase I
    Sample size
    135
  • Website
    Registered(PACTR201701001921166)
    Intellectual property
    Yes
    Preclinical study
    Completed
    Sponsoring company
    Yes
    Planning of licensing-out
    Planned
    Domestic funding
    Yes
    Funding abroad
    None in any countries
    Contract
    Completed in all countries
    Procurement of investigational product
    Completed in all countries
  • Steering Committee
    Yes
    Development roadmap
    Not fixed yet
    Stage of the study
    ---
    Protocol
    Using a single protocol as a single study
    IRB application
    Completed in all countries
    Data management
    Abroad
    Monitoring
    On-site monitoring
    Consultation with regulatory authorities
    Completed in some of the countries
Current issues & challenges
(request for support, etc.)
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