Safety and immunogenicity of a broad-spectrum mosaic vaccine as a booster dose against SARS-CoV-2 Omicron and other circulating variants
Kaabi, N. A.; Yang, Y. K.; Liang, Y.; Xu, K.; Zhang, X. F.; Kang, Y.; Jin, Y. Q.; Hou, J. W.; Zhang, J.; Yang, T.; Hussein, S.; ElDein, M. S.; Lei, Z. H.; Zhang, H.; Shao, S.; Liu, Z. M.; Liu, N.; Zheng, X.; Su, J. G.; Yang, S. S.; Cong, X. F.; Tan, Y.; Lei, W. W.; Gao, X. J.; Jiang, Z. W.; Wang, H.; Li, M.; Mekki, H. M.; Zaher, W.; Mahmoud, S.; Zhang, X.; Qu, C.; Liu, D. Y.; Zhang, J.; Yang, M. J.; Eltantawy, I.; Xiao, P.; Shen, F. J.; Wu, J. J.; Han, Z. B.; Du, L. F.; Tang, F.; Chen, S.; Ma, Z. J.; Zheng, F.; Hou, Y. N.; Li, X. Y.; Li, X.; Wang, Z. N.; Yin, J. L.; Mao, X. Y.; Zhang, J.; Qu,
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BACKGROUNDThe rising breakthrough infections caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants, especially Omicron and its sub-lineages, have raised an urgent need to develop broad-spectrum vaccines against coronavirus disease 2019 (COVID-19). We have developed a mosaic-type recombinant vaccine candidate, named NVSI-06-09, having immune potentials against a broad range of SARS-CoV-2 variants. METHODSAn ongoing randomized, double-blind, controlled phase 2 trial was conducted to evaluate the safety and immunogenicity of NVSI-06-09 as a booster dose in subjects aged 18 years and older from the United Arab Emirates (UAE), who had completed two or three doses of BBIBP-CorV vaccinations at least 6 months prior to the enrollment. The participants were randomly assigned with 1:1 to receive a booster dose of NVSI-06-09 or BBIBP-CorV. The primary outcomes were immunogenicity and safety against SARS-CoV-2 Omicron variant, and the exploratory outcome was cross-immunogenicity against other circulating strains. RESULTSA total of 516 participants received booster vaccination. Interim results showed a similar safety profile between NVSI-06-09 and BBIBP-CorV booster groups, with low incidence of adverse reactions of grade 1 or 2. For immunogenicity, by day 14 after the booster vaccination, the fold rises in neutralizing antibody geometric mean titers (GMTs) from baseline level elicited by NVSI-06-09 were remarkably higher than those by BBIBP-CorV against the prototype strain (19.67 vs 4.47-fold), Omicron BA.1.1 (42.35 vs 3.78-fold), BA.2 (25.09 vs 2.91-fold), BA.4 (22.42 vs 2.69-fold), and BA.5 variants (27.06 vs 4.73-fold). Similarly, the neutralizing GMTs boosted by NVSI-06-09 against Beta and Delta variants were also 6.60-fold and 7.17-fold higher than those boosted by BBIBP-CorV. CONCLUSIONSA booster dose of NVSI-06-09 was well-tolerated and elicited broad-spectrum neutralizing responses against SARS-CoV-2 prototype strain and immune-evasive variants, including Omicron and its sub-lineages. The immunogenicity of NVSI-06-09 as a booster vaccine was superior to that of BBIBP-CorV. (Funded by LIBP and BIBP of Sinopharm; ClinicalTrials.gov number, NCT05293548).
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