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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.

Principal Institution

Osaka University (OU), Japan

Principal Investigators / Focal Persons

Toshihiro Horii

Rationale and Abstract

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.

Thematic Categories

Product Development
Vaccines (Immune Correlates)

Date

Apr 2020 — Mar 2021

Total Project Funding

$120,932

Funding Details

Japan Agency for Medical Research and Development (AMED), Japan

Grant ID: 20lm0203135h0001

JPY 13M

Project Site

Japan

Higher level clinical trial aiming at practical application of malaria vaccine effective for endemic area residents and travelers

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