Acknowledgments
The study was funded by Medigen Vaccine Biologics (study sponsor), the Taiwan Centers for Disease Control and Ministry of Health and Welfare. The sponsor co-designed the trial and coordinated interactions with contract Clinical Research Organization (CRO) staff and regulatory authorities. The CRO operated trial operation to meet the standards of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and good clinical practice guidelines. The IDMC oversaw the safety data and communicated recommendations to the sponsor. The interim analysis was done by the CRO. We thank Stanley Chang, and Charles Chen at Medigen Vaccine Biologics; the investigational staff at National Taiwan University Hospital, Taiwan Taipei Veterans General Hospital, Tri-Service General Hospital, Taipei Veterans General Hospital, Taipei Medical University Hospital, Taipei Municipal Wan Fang Hospital, Linkou Chang Gung Memorial Hospital, Taoyuan General Hospital Ministry of Health and Welfare, China Medical University Hospital, Changhua Christian Hospital, National Cheng Kung University Hospital, and Kaohsiung Medical University Chung-Ho Memorial Hospital, for their dedication to this trial; the Clinipace Clinical Research team (Taipei, Taiwan), for their involvement in conducting the trial; Barney S Graham at the Vaccine Research Centre, US National Institute of Allergy and Infectious Diseases, for the development of S-2P pre-fusion protein; Robert Janssen at Dynavax Technologies for providing the CpG 1018 adjuvant and related important intellectual content; members at Protech Pharmaservices (Taipei, Taiwan) for conducting the spike-specific IgG ELISA assay; members at the Department of Laboratory Medicine, Linkou Chang Gung Memorial Hospital (Taoyuan, Taiwan), and members at Institute of Biomedical Sciences, Academia Sinica (Taipei, Taiwan) for conducting the neutralisation assay.
Ethics approval
Institutional review board of Linkou Chang Gung Memorial Hospital had approved the version 2.0, 29-DEC-2020 protocol of the main study (202002080A0C601), and then the other study sites could follow the approval in fast track. So as the approval of the substudy of HIV approved by IRB of Taoyuan General Hospital Ministry of Health and Welfare (TYGH110043). The study and all associated methods were performed in accordance with the approved protocol, the principles of the Declaration of Helsinki, and Good Clinical Practice guidelines.
Authors’ Contributions
S-HC, CEL and W-SL conceived and designed the study. W-SL, C-YC, W-DL, C-HL, W-CK, Y-HC, H-TC, H-JH, C-TH, S-JH, N-CW, M-CL, and Y-LL acquired and interpreted the data. CEL, I-CT, and JAGE analyzed the data. S-HC, W-SL, and CEL drafted and prepared the manuscript. CEL, and I-CT had full access to and verified all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. S-HC, CEL and W-SL reviewed and edited the final version, and S-HC, CEL, W-SL, and T-YL had final responsibility for the decision to submit for publication. All authors have read and approved the final manuscript.
Conflicts of interests
CEL, JAGE and I-CT are employees of Medigen Vaccine Biologics (Taipei, Taiwan) and they received grants from Taiwan Centers for Disease Control, Ministry of Health and Welfare, during the conduct of the study.
Shu-Hsing Cheng, Szu-Min Hsieh, Chien-Yu Cheng, Wang-Da Liu, Ching-Lung Lo, Wen-Chien Ko, Yen-Hsu Chen, Ching-Tai Huang, Hsiao-Ting Chang, Shinn-Jang Hwang, Ning-Chi Wang, Ming-Che Liu , Yu-Lin Lee, , Tzou-Yien Lin, and Wen-Sen Lee had nothing to declare.
Data availability
The datasets generated and/or analyzed during the current study are not publicly available as it is an interim analysis of data from an ongoing study.