tetano
Editor, Senior Moderator
Expert Rev Vaccines
. 2024 Jan-Dec;23(1):498-509.
doi: 10.1080/14760584.2024.2337051. Epub 2024 May 2. Safety and immunogenicity of the SARS-CoV-2 LYB001 RBD-based VLP vaccine (CHO cell) phase 1 in Chinese adults: a randomized, double-blind, positive-parallel-controlled study
Rong Tang[SUP] 1 [/SUP], Ying Zeng[SUP] 2 3 [/SUP], Yu Zhou[SUP] 2 3 [/SUP], Qi Liang[SUP] 4 [/SUP], Wei Kang[SUP] 2 3 [/SUP], Zhonghua Yang[SUP] 2 3 [/SUP], Xiaoxiang Zheng[SUP] 5 [/SUP], Xia Zang[SUP] 5 [/SUP], Hongxing Pan[SUP] 1 [/SUP], Jing Jin[SUP] 2 3 [/SUP], Fengcai Zhu[SUP] 1 [/SUP]
Affiliations
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).
Keywords: COVID-19 vaccine; immunogenicity; recombinant protein; safety; tolerance; virus-like particle (VLP).
. 2024 Jan-Dec;23(1):498-509.
doi: 10.1080/14760584.2024.2337051. Epub 2024 May 2. Safety and immunogenicity of the SARS-CoV-2 LYB001 RBD-based VLP vaccine (CHO cell) phase 1 in Chinese adults: a randomized, double-blind, positive-parallel-controlled study
Rong Tang[SUP] 1 [/SUP], Ying Zeng[SUP] 2 3 [/SUP], Yu Zhou[SUP] 2 3 [/SUP], Qi Liang[SUP] 4 [/SUP], Wei Kang[SUP] 2 3 [/SUP], Zhonghua Yang[SUP] 2 3 [/SUP], Xiaoxiang Zheng[SUP] 5 [/SUP], Xia Zang[SUP] 5 [/SUP], Hongxing Pan[SUP] 1 [/SUP], Jing Jin[SUP] 2 3 [/SUP], Fengcai Zhu[SUP] 1 [/SUP]
Affiliations
- PMID: 38695310
- DOI: 10.1080/14760584.2024.2337051
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).
Keywords: COVID-19 vaccine; immunogenicity; recombinant protein; safety; tolerance; virus-like particle (VLP).