A clinical phase1 study of Hydroxypropyl-beta-cyclodextrin (HPBCD)-adjuvanted influenza split vaccine

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Osaka University Hospital with the support of Daichii Sankyo is sponsoring a clinical trial on a vaccine against influenza virus.

In HPBCD-containing vaccine group, subjects are administered influenza HA split-vaccine containing 9 micro-g/HA/dose and 20%W/V HP-beta-CyD with a dose of 0.5mL in subcutaneous route. In standard vaccine group, subjects are administered influenza HA split-vaccine containing 15 micro-g/HA/dose with a dose of 0.5mL in subcutaneous route.

The primary outcome of the study is to assess the rate of adverse events elicited during 7 days after subcutaneous injection of HPBCD adjuvanted influenza split vaccine.

The research group of professors Etsushi Kuroda and Ken J. Ishii have been working on using cyclodextrins, in particular HPBCD as vaccine adjuvant for years, results are so far encouraging. These publications suggest that HPBCD acts as a potent MyD88- and TBK1-dependent T follicular helper cell adjuvant and is readily applicable to various vaccines.

 

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