CONTRIBUTORS
NTH, X-HN, LTLT, VTN, SGH, and KL participated in the design, protocol development and conduct of the study. NTH, SGH, BG, and IS participated in verifying the underlying data reported in the manuscript. JME reviewed the study results and provided critical review of the manuscript. SP, BS, SS, QR, BC, PC, and BL participated in vaccine development, optimization, manufacturing control, and vaccine release for clinical use. BG, IS, NTH and PC oversaw and participated in the data analysis plan, data analysis and manuscript preparation. VTN, X-HN, KM, and DB had overall management of the study. X-HN, NTHN, H-SV, and RS oversaw laboratory testing and analyses. LTLT, ATVL, and ANN oversaw study operations. VTT, ATVP, TVuN, LPT, HNP, MVC, MTND, QVT, QCL, TTN, VTTL, QD, LVN, and TVanN oversaw study conduct at sites.
CONFLICTS OF INTEREST
SH, SP, BS, SS, QR, BC, BL, KL, DB, KM, RS, BG, IS and PC are or were all full-time employees of the vaccine manufacturer and study sponsor, Arcturus Therapeutics, Inc. and JME is a full-time employee of CSL Sequiris which has entered into a collaboration agreement with Arcturus Therapeutics, Inc, for sa-mRNA vaccine. TTLL and NTV are employees of the vaccine licensee, Vietnam Biocare Biotechnology Jointstock Company. Other authors declare no conflicts.
ACKNOWLEDGEMENTS
The authors are grateful to the study staff at Hanoi Medical University, Pasteur Institute Hochiminh City, and Vietnam Military Medical University for assisting with study conduct; Hang Thi Vi, Trang Thu Hoang, Huong Vu Quynh Ngo, Ha Thai Pham, and Ngan Thi Le (Vietnam Biocare Biotechnology Jointstock Company) for contributing to study oversight; Lan Quynh Phan (Vinmec Healthcare System) for investigational product oversight; Anh-Tien Ngo (Hi-Tech Center, Vinmec Healthcare System) for sample processing and storage; Prof. Duc-Anh Dang, Thi-Khanh-Hang Le, NIHE and Vu-Tien Phan (Pasteur Institute Nha Trang) for immunogenicity assays; VietStar Biomedical Research for participating in study conduct and management. Hongfan Jin co-ordinated laboratory testing, Cindy Fisher, Ye Zhang and Pamela Resch participated in discussions with regulatory authorities regarding the protocol and development plan, and Deep Patel, Mukunda Krishna, Charles Cabral, and Claudia Averbuj provided expert support in drug product development, manufacturing and supply. We thank Keith Veitch (keithveitch communications, Amsterdam, The Netherlands) for editorial assistance in the preparation of the manuscript.
Funding
The study was co-funded by Vinbiocare Biotechnology Joint Stock Company (Hanoi, Vietnam) and Arcturus Therapeutics Inc. (CA, USA).
Trial registration:
ClinicalTrial.gov identifier: NCT05012943.