https://bio.nikkeibp.co.jp/atcl/news/p1/24/05/15/11904/
Sumitomo Pharma and the National Institute of Biomedical Innovation, Health and Nutrition (NIBIOHN) will start Phase I clinical trials for fH1/DSP-0546LP, a universal influenza vaccine for influenza type A, even if a mutation occurs. Membrane-fused hemagglutinin will be used as the antigen. The membrane-fused hemagglutinin used as an antigen is made by changing the structure of normal hemagglutinin to expose an epitope that is common to various influenza viruses. In addition, fH1/DSP-0546LP uses DSP-0546LP as an adjuvant, which contains a substance that specifically activates TLR7, one of Toll-like receptors. It is intended to enhance the immune response and its persistence by the vaccine.
The Phase I clinical trial of fH1/DSP-0546LP will be conducted in Belgium in July 2024. It will target subtypes of seasonal influenza A that have antigens highly homologous to the membrane-fused hemagglutinin to be used, with the aim of covering all subtypes of seasonal influenza A in the future. Several dozen patients will be included in each group, which will include a placebo group, antigen alone, and adjuvant alone.
In order to verify the efficacy of the vaccine in Phase II and later clinical trials, the company plans to conduct a virus exposure study in which subjects participating in the clinical trials will be infected with influenza viruses, but at this time the number of regions in the world where exposure studies are possible is limited. Belgium allows exposure testing. The Phase II clinical trial will also be conducted in Belgium, with plans to obtain proof of concept (POC) by exposing vaccinated subjects to influenza viruses and evaluating whether infection can be prevented.