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Last Updated: 18/06/2024
Higher level clinical trial aiming at practical application of malaria vaccine effective for endemic area residents and travelers
Objectives
In order to show the equivalence of CpG (Oligodeoxynucleotides), this project will test the physicochemical properties and immunogenicity, and conduct a repeated toxicity test based on GLP.
In order to carry out Phase IIb clinical trials in endemic areas of Africa and Phase IIa clinical trials by CHMI in Germany with new clinical trial products, the purpose of this research project is the following research and development. For investigational drugs manufactured by the new CMO, KMB, during the period of this study plan, the conventional SE36 / AHG, the newly manufactured SE36 / AHG, and the SE36 / are based on the recommendations of the German regulatory authority PEI. In order to show the equivalence of CpG, the physicochemical properties and immunogenicity of both will be tested, and a repeated toxicity test based on GLP will be conducted. In addition, a protocol will be prepared in consultation with the partner collaborators for Phase IIb clinical trials in Africa and Phase IIa clinical trials in Germany.
Apr 2020 — Mar 2021
$120,932
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