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Preparatory phase II for the malaria vaccine candidate NPC-SE36/CpG
1. In the SEmalvac2 project, a safety and immunogenicity phase Ib trial is underway 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 the 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 aluminum hydroxide (NPC-SE36 vaccine), manufacture a new CpG-ODN (K3) adjuvant GMP lot; and select sites and prepare a 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.
TARGET DISEASE: Malaria | Blood stage
TIMELINE: 01 April 2020 to 30 June 2021
COORDINATOR: European Vaccine Initiative
FUNDER: GHIT Fund and Nobelpharma
FUNDING: € 4.2 Mio
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