SE36 is a blood stage malaria vaccine candidate that primarily targets young children in endemic areas to reduce morbidity and mortality due to malaria. Though in principle all stages of parasite development are potential vaccine targets, the blood stage is the one that causes the symptoms of malaria and its complications, and thus has a public health impact. A blood-stage vaccine, either alone or as a component of a multi-stage vaccine, is needed to protect against clinical or epidemic malaria.
Early stage clinical trials have demonstrated that the BK-SE36 vaccine, SE36 recombinant protein and aluminium hydroxide gel, is well tolerated and is immunogenic. Moreover, a better immune response was achieved in Japanese adults when CpG-ODN (K3) adjuvant was added to the formulation. In the SEmalvac2 project, a safety and immunogenicity phase Ib trial isunderway in adults to 1-year old children in Burkina Faso with this new formulation. Preliminary results do not indicate unexpected safety concerns.
The SEmalvac4 project builds on these initial trials and allows the next step in further clinical development before the start of phase II proof-of-concept clinical trial.
This project aims to test the quality of a new and larger batch of SE36 vaccine adsorbed on aluminium hydroxide (NPC-SE36 vaccine), manufacture new CpG-ODN (K3) adjuvant GMP lot; and select sites and prepare protocol for phase IIb clinical trial. Successful development of a large-scale formulation will enable to have a vaccine that can be used for multi-site trials. Moreover, a well-designed phase IIb protocol with selected clinical sites ready to implement the phase IIb clinical trial would address the safety and efficacy of NPC-SE36 in a malaria endemic area.