tetano
Editor, Senior Moderator
Signal Transduct Target Ther
. 2023 Jan 3;8(1):20.
doi: 10.1038/s41392-022-01295-2.
Safety and immunogenicity of a mosaic vaccine booster against Omicron and other SARS-CoV-2 variants: a randomized phase 2 trial
Nawal Al Kaabi[SUP] #[/SUP][SUP] 1 2 [/SUP], Yun Kai Yang[SUP] #[/SUP][SUP] 3 [/SUP], Yu Liang[SUP] #[/SUP][SUP] 4 5 [/SUP], Ke Xu[SUP] #[/SUP][SUP] 6 [/SUP], Xue Feng Zhang[SUP] 4 5 [/SUP], Yun Kang[SUP] 5 7 [/SUP], Yu Qin Jin[SUP] 4 5 [/SUP], Jun Wei Hou[SUP] 4 5 [/SUP], Jing Zhang[SUP] 4 5 [/SUP], Tian Yang[SUP] 3 [/SUP], Salah Hussein[SUP] 1 [/SUP], Mohamed Saif ElDein[SUP] 1 [/SUP], Ze Hua Lei[SUP] 4 5 [/SUP], Hao Zhang[SUP] 4 5 [/SUP], Shuai Shao[SUP] 4 5 [/SUP], Zhao Ming Liu[SUP] 4 5 [/SUP], Ning Liu[SUP] 4 5 [/SUP], Xiang Zheng[SUP] 4 5 [/SUP], Ji Guo Su[SUP] 4 5 [/SUP], Sen Sen Yang[SUP] 5 7 [/SUP], Xiangfeng Cong[SUP] 5 7 [/SUP], Yao Tan[SUP] 5 7 [/SUP], Wenwen Lei[SUP] 6 [/SUP], Xue Jun Gao[SUP] 8 [/SUP], Zhiwei Jiang[SUP] 9 [/SUP], Hui Wang[SUP] 10 [/SUP], Meng Li[SUP] 3 [/SUP], Hanadi Mekki Mekki[SUP] 11 [/SUP], Walid Zaher[SUP] 12 [/SUP], Sally Mahmoud[SUP] 12 [/SUP], Xue Zhang[SUP] 3 [/SUP], Chang Qu[SUP] 3 [/SUP], Dan Ying Liu[SUP] 3 [/SUP], Jing Zhang[SUP] 6 [/SUP], Mengjie Yang[SUP] 6 [/SUP], Islam Eltantawy[SUP] 12 [/SUP], Peng Xiao[SUP] 12 [/SUP], Fu Jie Shen[SUP] 4 5 [/SUP], Jin Juan Wu[SUP] 4 5 [/SUP], Zi Bo Han[SUP] 4 5 [/SUP], Li Fang Du[SUP] 4 5 [/SUP], Fang Tang[SUP] 4 5 [/SUP], Shi Chen[SUP] 4 5 [/SUP], Zhi Jing Ma[SUP] 4 5 [/SUP], Fan Zheng[SUP] 4 5 [/SUP], Ya Nan Hou[SUP] 4 5 [/SUP], Xin Yu Li[SUP] 4 5 [/SUP], Xin Li[SUP] 4 5 [/SUP], Zhao Nian Wang[SUP] 3 [/SUP], Jin Liang Yin[SUP] 3 [/SUP], Xiao Yan Mao[SUP] 8 [/SUP], Jin Zhang[SUP] 10 [/SUP], Liang Qu[SUP] 3 [/SUP], Yun Tao Zhang[SUP] 13 [/SUP], Xiao Ming Yang[SUP] 14 [/SUP], Guizhen Wu[SUP] 15 [/SUP], Qi Ming Li[SUP] 16 17 [/SUP]
Affiliations
Abstract
An ongoing randomized, double-blind, controlled phase 2 trial was conducted to evaluate the safety and immunogenicity of a mosaic-type recombinant vaccine candidate, named NVSI-06-09, as a booster dose in subjects aged 18 years and older from the United Arab Emirates (UAE), who had administered two or three doses of inactivated vaccine BBIBP-CorV at least 6 months prior to 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 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.
. 2023 Jan 3;8(1):20.
doi: 10.1038/s41392-022-01295-2.
Safety and immunogenicity of a mosaic vaccine booster against Omicron and other SARS-CoV-2 variants: a randomized phase 2 trial
Nawal Al Kaabi[SUP] #[/SUP][SUP] 1 2 [/SUP], Yun Kai Yang[SUP] #[/SUP][SUP] 3 [/SUP], Yu Liang[SUP] #[/SUP][SUP] 4 5 [/SUP], Ke Xu[SUP] #[/SUP][SUP] 6 [/SUP], Xue Feng Zhang[SUP] 4 5 [/SUP], Yun Kang[SUP] 5 7 [/SUP], Yu Qin Jin[SUP] 4 5 [/SUP], Jun Wei Hou[SUP] 4 5 [/SUP], Jing Zhang[SUP] 4 5 [/SUP], Tian Yang[SUP] 3 [/SUP], Salah Hussein[SUP] 1 [/SUP], Mohamed Saif ElDein[SUP] 1 [/SUP], Ze Hua Lei[SUP] 4 5 [/SUP], Hao Zhang[SUP] 4 5 [/SUP], Shuai Shao[SUP] 4 5 [/SUP], Zhao Ming Liu[SUP] 4 5 [/SUP], Ning Liu[SUP] 4 5 [/SUP], Xiang Zheng[SUP] 4 5 [/SUP], Ji Guo Su[SUP] 4 5 [/SUP], Sen Sen Yang[SUP] 5 7 [/SUP], Xiangfeng Cong[SUP] 5 7 [/SUP], Yao Tan[SUP] 5 7 [/SUP], Wenwen Lei[SUP] 6 [/SUP], Xue Jun Gao[SUP] 8 [/SUP], Zhiwei Jiang[SUP] 9 [/SUP], Hui Wang[SUP] 10 [/SUP], Meng Li[SUP] 3 [/SUP], Hanadi Mekki Mekki[SUP] 11 [/SUP], Walid Zaher[SUP] 12 [/SUP], Sally Mahmoud[SUP] 12 [/SUP], Xue Zhang[SUP] 3 [/SUP], Chang Qu[SUP] 3 [/SUP], Dan Ying Liu[SUP] 3 [/SUP], Jing Zhang[SUP] 6 [/SUP], Mengjie Yang[SUP] 6 [/SUP], Islam Eltantawy[SUP] 12 [/SUP], Peng Xiao[SUP] 12 [/SUP], Fu Jie Shen[SUP] 4 5 [/SUP], Jin Juan Wu[SUP] 4 5 [/SUP], Zi Bo Han[SUP] 4 5 [/SUP], Li Fang Du[SUP] 4 5 [/SUP], Fang Tang[SUP] 4 5 [/SUP], Shi Chen[SUP] 4 5 [/SUP], Zhi Jing Ma[SUP] 4 5 [/SUP], Fan Zheng[SUP] 4 5 [/SUP], Ya Nan Hou[SUP] 4 5 [/SUP], Xin Yu Li[SUP] 4 5 [/SUP], Xin Li[SUP] 4 5 [/SUP], Zhao Nian Wang[SUP] 3 [/SUP], Jin Liang Yin[SUP] 3 [/SUP], Xiao Yan Mao[SUP] 8 [/SUP], Jin Zhang[SUP] 10 [/SUP], Liang Qu[SUP] 3 [/SUP], Yun Tao Zhang[SUP] 13 [/SUP], Xiao Ming Yang[SUP] 14 [/SUP], Guizhen Wu[SUP] 15 [/SUP], Qi Ming Li[SUP] 16 17 [/SUP]
Affiliations
- PMID: 36596779
- DOI: 10.1038/s41392-022-01295-2
Abstract
An ongoing randomized, double-blind, controlled phase 2 trial was conducted to evaluate the safety and immunogenicity of a mosaic-type recombinant vaccine candidate, named NVSI-06-09, as a booster dose in subjects aged 18 years and older from the United Arab Emirates (UAE), who had administered two or three doses of inactivated vaccine BBIBP-CorV at least 6 months prior to 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 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.