Xie, Ran
Zhao, Nan
Jia, Bo
Zhao, Xia
Cui, Yimin http://orcid.org/0000-0002-4186-1005
Okamoto, Hiroyuki
Yang, Lili
Prokopienko, Alexander
Article History
Accepted: 25 October 2022
First Online: 18 November 2022
Declarations
:
: This work was supported by Takeda Development Center Asia, Pte. Ltd.
: Lili Yang, Alexander Prokopienko, and Hiroyuki Okamoto are employees of Takeda, which sponsored the clinical trial. Lili Yang, Alexander Prokopienko, and Hiroyuki Okamoto also own stock and/or stock options in Takeda. Other authors have no relevant conflicts of interest.
: All procedures performed in studies involving human participants were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Declaration of Helsinki and Good Clinical Practice Guidelines. The study was approved by the Ethics Committee of Peking University First Hospital (China).
: All subjects provided written informed consent prior to participation.
: Not applicable.
: Considered upon request.
: Not applicable.
: Y.C. and X.Z. contributed to the design of the study. Y.C., X.Z., R.X., N.Z., and B.J. performed the research and interpreted the data. Preparation of the initial manuscript was carried out by R.X. and N.Z. The manuscript was revised and approved by R.X., N.Z., B.J., X.Z., and Y.C. L.Y. contributed to exporting serum samples from China by providing technical/scientific rationale to OHGRA, overseeing the smooth running of the technical operations during the study in China, answering Chinese regulatory immunogenicity and neutralizing questions, providing the assay information, and reviewing this manuscript. A.P. contributed to the interpretation of the data and writing and reviewing the manuscript. H.O. contributed to the design of the study, analysis, and interpretation of the data.