Safety and immunogenicity of primary vaccination with a SARS-CoV-2 mRNA vaccine (SYS6006) in Chinese participants aged 18 years or more: Two randomized, observer-blinded, placebo-controlled and dose-escalation phase 1 clinical trials

References

• World Health Organization. Weekly epidemiological update on COVID-19; 2023 Aug 17 [accessed 2023 Aug 21]. https://www.who.int/publications/m/item/weekly-epidemiological-update-on-covid-19.
   Google Scholar
• Wang Q, Guo Y, Iketani S, Nair MS, Li Z, Mohri H, Wang M, Yu J, Bowen AD, Chang JY, et al. Antibody evasion by SARS-CoV-2 Omicron subvariants BA.2.12.1, BA.4 and BA.5. Nature. 2022;608(7923):603–14. doi:10.1038/s41586-022-05053-w.
   PubMed Web of Science ®Google Scholar
• Carabelli AM, Peacock TP, Thorne LG, Harvey WT, Hughes J, de Silva TI, Peacock SJ, Barclay WS, de Silva TI, Towers GJ, et al. COVID-19 Genomics UK Consortium, SARS-CoV-2 variant biology: immune escape, transmission and fitness. Nat Rev Microbiol. 2023;21:162–77. doi:10.1038/s41579-022-00841-7.
   PubMed Web of Science ®Google Scholar
• World Health Organization. COVID-19 vaccine tracker and landscape; [accessed 2023 May 19]. www.who.int/teams/blueprint/covid-19/covid-19-vaccine-tracker-and-landscape.
   Google Scholar
• Li J, Hui A, Zhang X, Yang Y, Tang R, Ye H, Ji R, Lin M, Zhu Z, Türeci Ö, et al. Safety and immunogenicity of the SARS-CoV-2 BNT162b1 mRNA vaccine in younger and older Chinese adults: a randomized, placebo-controlled, double-blind phase 1 study. Nat Med. 2021;27(6):1062–70. doi:10.1038/s41591-021-01330-9.
   PubMed Web of Science ®Google Scholar
• Hui AM, Li J, Zhu L, Tang R, Ye H, Lin M, Ge L, Wang X, Peng F, Wu Z, et al. Immunogenicity and safety of BNT162b2 mRNA vaccine in Chinese adults: a phase 2 randomized clinical trial. Lancet Reg Health West Pac. 2022;29:100586. doi:10.1016/j.lanwpc.2022.100586.
   PubMedGoogle Scholar
• Chen GL, Li XF, Dai XH, Li N, Cheng ML, Huang Z, Shen J, Ge Y-H, Shen Z-W, Deng Y-Q, et al. Safety and immunogenicity of the SARS-CoV-2 ARCoV mRNA vaccine in Chinese adults: a randomized, double-blind, placebo-controlled, phase 1 trial. Lancet Microbe. 2022;3:e193–e202. doi:10.1016/S2666-5247(21)00280-9.
   PubMedGoogle Scholar
• Zhang Y, Zeng G, Pan H, Li C, Hu Y, Chu K, Han W, Chen Z, Tang R, Yin W, et al. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18–59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021;21:181–92. doi:10.1016/S1473-3099(20)30843-4.
   PubMed Web of Science ®Google Scholar
• Yang S, Li Y, Dai L, Wang J, He P, Li C, Fang X, Wang C, Zhao X, Huang E, et al. Safety and immunogenicity of a recombinant tandem-repeat dimeric RBD-based protein subunit vaccine (ZF2001) against COVID-19 in adults: two randomized, double-blind, placebo-controlled, phase 1 and 2 trials. Lancet Infect Dis. 2021;21:1107–19. doi:10.1016/S1473-3099(21)00127-4.
   PubMed Web of Science ®Google Scholar
• Xu K, Lei W, Kang B, Yang H, Wang Y, Lu Y, Lv L, Sun Y, Zhang J, Wang X, et al. A novel mRNA vaccine, SYS6006, against SARS-CoV-2. Front Immunol. 2023;13:1051576. doi:10.3389/fimmu.2022.1051576.
   PubMed Web of Science ®Google Scholar
• China National Medical Products Administration. Guidelines for grading adverse events in clinical trials of prophylactic vaccines (2019 edition); [accessed 2023 Mar 24]. https://www.nmpa.gov.cn/yaopin/ypggtg/ypqtgg/20191231111901460.html.
   Google Scholar
• Feikin DR, Higdon MM, Abu-Raddad LJ, Andrews N, Araos R, Goldberg Y, Groome MJ, Huppert A, O’Brien KL, Smith PG, et al. Duration of effectiveness of vaccines against SARS-CoV-2 infection and COVID-19 disease: results of a systematic review and meta-regression. Lancet. 2022;399(10328):924–44. doi:10.1016/S0140-6736(22)00152-0.
   PubMed Web of Science ®Google Scholar
• Andrews N, Stowe J, Kirsebom F, Toffa S, Rickeard T, Gallagher E, Gower C, Kall M, Groves N, O’Connell A-M, et al. Covid-19 vaccine effectiveness against the Omicron (B.1.1.529) variant. N Engl J Med. 2022;386(16):1532–46. doi:10.1056/NEJMoa2119451.
   PubMed Web of Science ®Google Scholar
• Costa Clemens SA, Weckx L, Clemens R, Almeida Mendes AV, Ramos Souza A, Silveira MBV, da Guarda SNF, de Nobrega MM, de Moraes Pinto MI, Gonzalez IGS, et al. Heterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccine in Brazil (RHH-001): a phase 4, non-inferiority, single blind, randomized study. Lancet. 2022;399:521–9. doi:10.1016/S0140-6736(22)00094-0.
   PubMed Web of Science ®Google Scholar
• Liu X, Li Y, Wang Z, Cao S, Huang W, Yuan L, Huang Y-J, Zheng Y, Chen J, Ying B, et al. Safety and superior immunogenicity of heterologous boosting with an RBD-based SARS-CoV-2 mRNA vaccine in Chinese adults. Cell Res. 2022;32(8):777–80. doi:10.1038/s41422-022-00681-3.
   PubMed Web of Science ®Google Scholar
• Mallah SI, Alawadhi A, Jawad J, Wasif P, Alsaffar B, Alalawi E, Mohamed AM, Butler AE, Alalawi B, Qayed D, et al. Safety and efficacy of COVID-19 prime-boost vaccinations: homologous BBIBP-CorV versus heterologous BNT162b2 boosters in BBIBP-CorV-primed individuals. Vaccine. 2023;41(12):1925–33. doi:10.1016/j.vaccine.2023.01.032.
   PubMed Web of Science ®Google Scholar
• Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Pérez Marc G, Moreira ED, Zerbini C, et al. Safety and efficacy of the BNT162b2 mRNA covid-19 vaccine. N Engl J Med. 2020;383(27):2603–15. doi:10.1056/NEJMoa2034577.
   PubMed Web of Science ®Google Scholar
• Mulligan MJ, Lyke KE, Kitchin N, Absalon J, Gurtman A, Lockhart S, Neuzil K, Raabe V, Bailey R, Swanson KA, et al. Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults [published correction appears in Nature 2021 Feb;590(7844):E26]. Nature. 2020;586:589–93. doi:10.1038/s41586-020-2639-4.
   PubMed Web of Science ®Google Scholar
• Li J, Hui AM, Zhang X, Ge L, Qiu Y, Tang R, Ye H, Wang X, Lin M, Zhu Z, et al. Immune persistence and safety after SARS-CoV-2 BNT162b1 mRNA vaccination in Chinese adults: a randomized, placebo-controlled, double-blind phase 1 trial. Adv Ther. 2022;39(8):3789–98. doi:10.1007/s12325-022-02206-1.
   PubMed Web of Science ®Google Scholar
• Hachmann NP, Miller J, Collier AY, Ventura JD, Yu J, Rowe M, Bondzie EA, Powers O, Surve N, Hall K, et al. Neutralisation escape by SARS-CoV-2 Omicron subvariants BA.2.12.1, BA.4, and BA.5. N Engl J Med. 2022;387:86–8. doi:10.1056/NEJMc2206576.
   PubMed Web of Science ®Google Scholar
• Muik A, Lui BG, Wallisch AK, Bacher M, Mühl J, Reinholz J, Ozhelvaci O, Beckmann N, Güimil Garcia RDLC, Poran A, et al. Neutralization of SARS-CoV-2 Omicron by BNT162b2 mRNA vaccine–elicited human sera. Science. 2022;375:678–80. doi:10.1126/science.abn7591.
   PubMed Web of Science ®Google Scholar
• Xia H, Zou J, Kurhade C, Cai H, Yang Q, Cutler M, Cooper D, Muik A, Jansen KU, Xie X, et al. Neutralisation and durability of 2 or 3 doses of the BNT162b2 vaccine against Omicron SARS-CoV-2. Cell Host & Microbe. 2022;30:485–8.e3. doi:10.1016/j.chom.2022.02.015.
   PubMed Web of Science ®Google Scholar
• Jackson LA, Anderson EJ, Rouphael NG, Roberts PC, Makhene M, Coler RN, McCullough MP, Chappell JD, Denison MR, Stevens LJ, et al. An mRNA vaccine against SARS-CoV-2 – preliminary report. N Engl J Med. 2020;383:1920–31. doi:10.1056/NEJMoa2022483.
   PubMed Web of Science ®Google Scholar