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ABSTRACT
Background
Vaccination remains the cornerstone of defense against COVID-19 globally. This study aims to assess the safety and immunogenicity profile of innovative vaccines LYB001.
Research design and methods
This was a randomized, double-blind, parallel-controlled trial, in 100 healthy Chinese adults (21 to 72 years old). Three doses of 30 or 60 µg of SARS-CoV-2 RBD-based VLP vaccine (LYB001), or the SARS-CoV-2 RBD-based protein subunit vaccine (ZF2001, control group) were administered with a 28-day interval. Differences in the incidence of adverse events (AEs) and indicators of humoral and cellular immunity among the different groups were measured.
Results
No severe adverse events were confirmed to be vaccine-related, and there was no significant difference in the rate of adverse events between the LYB001 and control group or the age subgroups (p > 0.05). The LYB001 groups had significantly higher or comparable levels of seroconversion rates, neutralization antibody, S protein-binding antibody, and cellular immunity after whole vaccination than the control group.
Conclusions
Our findings support that LYB001 developed on the VLP platform is safe and well tolerated with favorable immunogenicity for fundamental vaccination in healthy adults. Therefore, further larger-scale clinical studies are warranted.
Trial Registration
This trial was registered with ClinicalTrials.gov (NCT05552573).
Declaration of interest
This research may lead to the development of products which may be licensed to Guangzhou Patronus Biotech Co., Ltd and Yantai Patronus Biotech Co., Ltd. J Jin, Y Zeng, Y Zhou, W Kang, and Z Yang are employed by Guangzhou Patronus Biotech Co. and Ltd and Yantai Patronus Biotech Co. The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or material discussed in the manuscript apart from those disclosed.
Reviewer disclosures
Peer reviewers on this manuscript have received honoraria for their review work. Peer reviewers on this manuscript have no other relevant financial or other relationships to disclose.
Author contributions
F Zhu, J Jin and H Pan initiated and designed the clinical research. Y Zeng and Z Yang contributed to the protocol and design of this study. F Zhu, H Pan, R Tang and Q Liang were responsible for supervision clinical trial and data management. Qi Liang, X Zheng and X Zang were responsible for sample collection and laboratory analysis. Y Zhou and W Kang was responsible for to the data processing and statistical analysis. W Kang, Y Zeng, Z Yang and Y Zhou drafted the manuscript. R Tang, J Jin and Y Zeng were responsible for the revision. F Zhu, J Jin and H Pan were in charge of approval. All authors reviewed and approved the final version of the manuscript. The data and decision to publish this study were reviewed and confirmed by all authors.
Acknowledgments
We thank all participants in our study for providing the clinical data and serum samples; and the Jiangsu Provincial Center for Disease Control and Prevention (Public Health Research institute of Jiangsu Province), for helping with clinical trial and relative work.
Data availability statement
Due to the dataset in this study is not open to the public, appropriate access to the dataset can be requested and addressed to the corresponding authors Fengcai Zhu at [email protected], or Jing Jin at [email protected]. There is no current URL for direct access to the dataset, but reasonable requests or collaboration can be made.
Supplementary material
Supplemental data for this article can be accessed online at https://doi.org/10.1080/14760584.2024.2337051.