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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 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron variant, and the exploratory outcome was cross-immunogenicity against other circulating strains. Between May 25 and 30, 2022, 516 adults received booster vaccination with 260 in NVSI-06-09 group and 256 in BBIBP-CorV group. Interim results showed a similar safety profile between two booster groups, with low incidence of adverse reactions of grade 1 or 2. For immunogenicity, by day 14 post-booster, the fold rises in neutralizing antibody geometric mean titers (GMTs) from baseline 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 by BBIBP-CorV. Our findings indicated that a booster dose of NVSI-06-09 was well-tolerated and elicited broad-spectrum neutralizing responses against divergent SARS-CoV-2 variants, including Omicron and its sub-lineages.<\/jats:p>","DOI":"10.1038\/s41392-022-01295-2","type":"journal-article","created":{"date-parts":[[2023,1,3]],"date-time":"2023-01-03T12:02:49Z","timestamp":1672747369000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Safety and immunogenicity of a mosaic vaccine booster against Omicron and other SARS-CoV-2 variants: a randomized phase 2 trial"],"prefix":"10.1038","volume":"8","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2180-4158","authenticated-orcid":false,"given":"Nawal Al","family":"Kaabi","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yun 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Y.L., X.F.Z., Y.K., Y.Q.J., J.W.H., JingZ.(NVSI), Z.H.L., H.Z., S.S., Z.M.L., N.L., X.Zheng, J.G.S., S.S.Y., X.F.C., Y.T., F.J.S., J.J.W., Z.B.H., L.F.D., F.T., S.C., Z.J.M., F.Z., Y.N.H., X.Y.L., X.L., and Q.M.L. are employed by the National Vaccine and Serum Institute (NVSI). X.J.G. and X.Y.M. are employed by Lanzhou Institute of Biological Products Company Limited (LIBP). H.W. and JinZ. are employed by Beijing Institute of Biological Products Company Limited (BIBP). Q.M.L., JingZ.(NVSI), Y.L., J.G.S., L.F.D., F.T., S.S., X.F.Z., Z.H.L., Z.M.L., Z.B.H., N.L., Y.Q.J., H.Z., J.W.H., Y.N.H., Z.J.M., S.C., F.Z., and F.J.S. are listed as inventors of the patent application for NVSI-06-09 vaccine (Application number: 202210083654.X). The other authors declare no competing interests.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"20"}}