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

References

• Coronavirus resource center at johns Hopkins university. [cited 2023 Mar 10]. Available from: https://github.com/CSSEGISandData/COVID-19
   Google Scholar
• Ma Y, Deng J, Liang W, et al. Meta-analysis of SARS-CoV-2 reinfection rate in the world. Chin J Dis Control Prev. 2023;27(2):127–135.
   Google Scholar
• Lazarus JV, Wyka K, White TM, et al. A survey of COVID-19 vaccine acceptance across 23 countries in 2022. Nat Med. 2023;29(2):366–375. doi: 10.1038/s41591-022-02185-4
   PubMed Web of Science ®Google Scholar
• COVID-19 vaccine tracker and landscape. [cited 2023 Mar 10]. Available from: https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines
   Google Scholar
• Li M, Wang H, Tian L, et al. COVID-19 vaccine development: milestones, lessons and prospects. Signal Transduct Target Ther. 2022;7(1):146. doi: 10.1038/s41392-022-00996-y
   PubMed Web of Science ®Google Scholar
• Dai L, Gao L, Tao L, et al. Efficacy and safety of the RBD-dimer–based COVID-19 vaccine ZF2001 in adults. N Engl J Med. 2022;386(22):2097–2111. doi: 10.1056/NEJMoa2202261
   PubMed Web of Science ®Google Scholar
• Kleanthous H, Silverman JM, Makar KW, et al. Scientific rationale for developing potent RBD-based vaccines targeting COVID-19. NPJ Vaccin. 2021;6(1):128. doi: 10.1038/s41541-021-00393-6
   PubMed Web of Science ®Google Scholar
• Zhao X, Zheng A, Li D, et al. Neutralisation of ZF2001-elicited antisera to SARS-CoV-2 variants. Lancet Microbe. 2021;2(10):e494. doi: 10.1016/S2666-5247(21)00217-2
   PubMedGoogle Scholar
• Brisse M, Vrba SM, Kirk N, et al. Emerging concepts and technologies in vaccine development. Front Immunol. 2020;11:583077. doi: 10.3389/fimmu.2020.583077
   PubMed Web of Science ®Google Scholar
• Yang S, Li Y, Dai L, et al. Safety and immunogenicity of a recombinant tandem-repeat dimeric RBD-based protein subunit vaccine (ZF2001) against COVID-19 in adults: two randomised, double-blind, placebo-controlled, phase 1 and 2 trials. Lancet Infect Dis. 2021;21(8):1107–1119. doi: 10.1016/S1473-3099(21)00127-4
   PubMed Web of Science ®Google Scholar
• Zhao X, Zhang R, Qiao S, et al. Omicron SARS-CoV-2 neutralization from inactivated and ZF2001 vaccines. N Engl J Med. 2022;387(3):277–280. doi: 10.1056/NEJMc2206900
   PubMed Web of Science ®Google Scholar
• Ma X, Zou F, Yu F, et al. Nanoparticle vaccines based on the receptor binding domain (RBD) and heptad repeat (HR) of SARS-CoV-2 elicit robust protective immune responses. Immunity. 2020;53(6):1315–1330.e9. doi: 10.1016/j.immuni.2020.11.015
   PubMed Web of Science ®Google Scholar
• Shi J, Zhao Y, Peng M, et al. Screening of efficient adjuvants for the RBD-based subunit vaccine of SARS-CoV-2. Vaccines. 2023;11(4):713. doi: 10.3390/vaccines11040713
   Web of Science ®Google Scholar
• Firdaus FZ, Skwarczynski M, Toth I. Developments in vaccine adjuvants. Methods Mol Biol. 2022;2412:145–178.
   PubMedGoogle Scholar
• Kim E, Attia Z, Woodfint RM, et al. Inhibition of elastase enhances the adjuvanticity of alum and promotes anti-SARS-CoV-2 systemic and mucosal immunity. Proc Natl Acad Sci USA. 2021;118(34):e2102435118. doi: 10.1073/pnas.2102435118
   PubMed Web of Science ®Google Scholar
• Pino M, Abid T, Pereira Ribeiro S, et al. A yeast expressed RBD-based SARS-CoV-2 vaccine formulated with 3M-052-alum adjuvant promotes protective efficacy in non-human primates. Sci Immunol. 2021;6(61):eabh3634. doi: 10.1126/sciimmunol.abh3634
   PubMed Web of Science ®Google Scholar
• Routhu NK, Cheedarla N, Bollimpelli VS, et al. SARS-CoV-2 RBD trimer protein adjuvanted with alum-3M-052 protects from SARS-CoV-2 infection and immune pathology in the lung. Nat Commun. 2021;12(1):3587. doi: 10.1038/s41467-021-23942-y
   PubMed Web of Science ®Google Scholar
• Guo W, Duan K, Zhang Y, et al. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18 years or older: a randomized, double-blind, placebo-controlled, phase 1/2 trial. EClinicalmedicine. 2021;38:101010. doi: 10.1016/j.eclinm.2021.101010
   PubMedGoogle Scholar
• Bravo L, Smolenov I, Han HH, et al. Efficacy of the adjuvanted subunit protein COVID-19 vaccine, SCB-2019: a phase 2 and 3 multicentre, double-blind, randomised, placebo-controlled trial. Lancet. 2022;399(10323):461–472. doi: 10.1016/S0140-6736(22)00055-1
   PubMed Web of Science ®Google Scholar
• Zhou J, Liu Z, Zhang G, et al. Development of variant‐proof severe acute respiratory syndrome coronavirus 2, pan‐sarbecovirus, and pan‐β‐coronavirus vaccines. J Med Virol. 2023;95(1):e28172. doi: 10.1002/jmv.28172
   PubMedGoogle Scholar
• Cohen AA, van Doremalen N, Greaney AJ, et al. Mosaic RBD nanoparticles protect against challenge by diverse sarbecoviruses in animal models. Science. 2022;377(6606):eabq0839. doi: 10.1126/science.abq0839
   PubMed Web of Science ®Google Scholar
• Cohen AA, Gnanapragasam PNP, Lee YE, et al. Mosaic nanoparticles elicit cross-reactive immune responses to zoonotic coronaviruses in mice. Science. 2021;371(6530):735–741. doi: 10.1126/science.abf6840
   PubMed Web of Science ®Google Scholar
• Li Y, Zhang Y, Zhou Y, et al. An RBD virus-like particle vaccine for SARS-CoV-2 induces cross-variant antibody responses in mice and macaques. Signal Transduct Target Ther. 2023;8(1):173. doi: 10.1038/s41392-023-01425-4
   PubMed Web of Science ®Google Scholar
• Ward BJ, Gobeil P, Séguin A, et al. Phase 1 randomized trial of a plant-derived virus-like particle vaccine for COVID-19. Nat Med. 2021;27(6):1071–1078. doi: 10.1038/s41591-021-01370-1
   PubMed Web of Science ®Google Scholar
• Song JY, Choi WS, Heo JY, et al. Safety and immunogenicity of a SARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510) adjuvanted with AS03: a randomised, placebo-controlled, observer-blinded phase 1/2 trial. EClinicalmedicine. 2022;51:101569.
   PubMedGoogle Scholar
• Smit MJ, Sander AF, Ariaans MBPA, et al. First-in-human use of a modular capsid virus-like vaccine platform: an open-label, non-randomised, phase 1 clinical trial of the SARS-CoV-2 vaccine ABNCoV2. Lancet Microbe. 2023;4(3):e140–e148. doi: 10.1016/S2666-5247(22)00337-8
   PubMedGoogle Scholar
• Khoury DS, Cromer D, Reynaldi A, et al. Neutralizing antibody levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection. Nat Med. 2021;27(7):1205–1211. doi: 10.1038/s41591-021-01377-8
   PubMed Web of Science ®Google Scholar
• Yong X, Liu J, Zeng Y, et al. Safety and immunogenicity of a heterologous booster with an RBD virus-like particle vaccine following two- or three-dose inactivated COVID-19 vaccine. Hum Vaccin Immunother. 2023;19(3):2267869. doi: 10.1080/21645515.2023.2267869
   PubMed Web of Science ®Google Scholar