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| 1 | Immunogenicity and safety of NVSI-06-07 as a heterologous booster after priming with BBIBP-CorV:a phase 2 trial显示文摘The increased coronavirus disease 2019(COVID-19)breakthrough cases pose the need of booster vaccination.We conducted a randomised,double-blinded,controlled,phase 2 trial to assess the immunogenicity and safety of the heterologous prime-boost vaccination with an inactivated COVID-19 vaccine(BBIBP-CorV)followed by a recombinant protein-based vaccine(NVSI-06-07),using homologous boost with BBIBP-CorV as control.Three groups of healthy adults(600 individuals per group)who had completed two-dose BBIBP-CorV vaccinations 1–3 months,4–6 months and≥6 months earlier,respectively,were randomly assigned in a 1:1 ratio to receive either NVSI-06-07 or BBIBP-CorV boost.Immunogenicity assays showed that in NVSI-06-07 groups,neutralizing antibody geometric mean titers(GMTs)against the prototype SARS-CoV-2 increased by 21.01–63.85 folds on day 28 after vaccination,whereas only 4.20–16.78 folds of increases were observed in control groups.For Omicron variant,the neutralizing antibody GMT elicited by homologous boost was 37.91 on day 14,however,a significantly higher neutralizing GMT of 292.53 was induced by heterologous booster.Similar results were obtained for other SARS-CoV-2 variants of concerns(VOCs),including Alpha,Beta and Delta.Both heterologous and homologous boosters have a good safety profile.Local and systemic adverse reactions were absent,mild or moderate in most participants,and the overall safety was quite similar between two booster schemes.Our findings indicated that NVSI-06-07 is safe and immunogenic as a heterologous booster in BBIBP-CorV recipients and was immunogenically superior to the homologous booster against not only SARS-CoV-2 prototype strain but also VOCs,including Omicron. | Nawal Al Kaabi Yun Kai Yang Jing Zhang Ke Xu Yu Liang Yun Kang Ji Guo Su Tian Yang Salah Hussein Mohamed Saif ElDein Shuai Shao Sen Sen Yang Wenwen Lei Xue Jun Gao Zhiwei Jiang Hui Wang Meng Li Hanadi Mekki Mekki Walid Zaher Sally Mahmoud Xue Zhang Chang Qu Dan Ying Liu Jing Zhang Mengjie Yang Islam Eltantawy Peng Xiao Zhao Nian Wang Jin Liang Yin Xiao Yan Mao Jin Zhang Ning Liu Fu Jie Shen Liang Qu Yun Tao Zhang Xiao Ming Yang Guizhen Wu Qi Ming Li | 2022 | Signal Transduction and Targeted Therapy2022，7，7： | 2 |
| 2 | Procalcitonin and interleukin 6 for predicting blood culture positivity in sepsis显示文摘 | Mohammad Naffaa Badira F. Makhoul Amjad Tobia Marielle Kaplan Doron Aronson Zaher S. Azzam Walid Saliba | 2013 | American Journal of Emergency Medicine2013，，： | 1 |
| 3 | Safety and immunogenicity of a mosaic vaccine booster against Omicron and other SARS-CoV-2 variants:a randomized phase 2 trial显示文摘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. | Nawal Al Kaabi Yun Kai Yang Yu Liang Ke Xu Xue Feng Zhang Yun Kang Yu Qin Jin Jun Wei Hou Jing Zhang Tian Yang Salah Hussein Mohamed Saif ElDein Ze Hua Lei Hao Zhang Shuai Shao Zhao Ming Liu Ning Liu Xiang Zheng Ji Guo Su Sen Sen Yang Xiangfeng Cong Yao Tan Wenwen Lei Xue Jun Gao Zhiwei Jiang Hui Wang Meng Li Hanadi Mekki Mekki Walid Zaher Sally Mahmoud Xue Zhang Chang Qu Dan Ying Liu Jing Zhang Mengjie Yang Islam Eltantawy Peng Xiao Fu Jie Shen Jin Juan Wu Zi Bo Han Li Fang Du Fang Tang Shi Chen Zhi Jing Ma Fan Zheng Ya Nan Hou Xin Yu Li Xin Li Zhao Nian Wang Jin Liang Yin Xiao Yan Mao Jin Zhang Liang Qu Yun Tao Zhang Xiao Ming Yang Guizhen Wu Qi Ming Li | 2023 | Signal Transduction and Targeted Therapy2023，8，2： | 0 |
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