Clinical development of the BK-SE36 malaria vaccine candidate

Clinical development of the BK-SE36 malaria vaccine candidate

Objectives

BK-SE36 is a so-called blood stage malaria vaccine candidate that is primarily primarily intended for young children in endemic areas to control levels of the malaria parasite, resulting in reduction of morbidity and mortality caused by the disease.

In this project, a phase Ib clinical trial with the BK-SE36 vaccine candidate will be conducted in Burkina Faso with the aim to

1. Compare the clinical trial results from Burkina Faso with those from a previous clinical trial conducted in Uganda which has slightly different malaria disease characteristics,

2. Test the vaccine candidate in a younger age group (0-5 years old) that has not been included so far in any of the other clinical trial testing of BK-SE36, and 3. Generate additional information on safety, immunogenicity and possible efficacy.

In addition, the project aims to conduct a follow-up study of Japanese volunteers that participated in a first-in-man trial of BK-SE36 with a different adjuvant, a substance that enhances a persons’ response to the vaccine. The follow-up study would allow long term evaluation of the safety and immunogenicity of BK-SE36/CpG.

PI Institution(s)

Funding source(s)

Partner(s)

Key facts

  • Funding amount
    $999,999

MESA tags

  • Methodology
    Product development & clinical research