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Safety and immunogenicity of a broad-spectrum mosaic vaccine as a booster dose against SARS-CoV-2 Omicron and other circulating variants
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; Xiang Feng Cong; Yao Tan; Wen Wen Lei; Xue Jun Gao; Zhi Wei Jiang; Hui Wang; Meng Li; Hanadi Mekki Mekki; Walid Zaher; Sally Mahmoud; Xue Zhang; Chang Qu; Dan Ying Liu; Jing Zhang; Meng Jie 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.
  • Nawal Al Kaabi; Sheikh Khalifa Medical City
  • Yun Kai Yang; China National Biotec Group Company Limited
  • Yu Liang; National Vaccine and Serum Institute (NVSI)
  • Ke Xu; National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention (China CDC)
  • Xue Feng Zhang; National Vaccine and Serum Institute (NVSI)
  • Yun Kang; National Vaccine and Serum Institute (NVSI)
  • Yu Qin Jin; National Vaccine and Serum Institute (NVSI)
  • Jun Wei Hou; National Vaccine and Serum Institute (NVSI)
  • Jing Zhang; National Vaccine and Serum Institute (NVSI)
  • Tian Yang; China National Biotec Group Company Limited
  • Salah Hussein; Sheikh Khalifa Medical City
  • Mohamed Saif ElDein; Sheikh Khalifa Medical City
  • Ze Hua Lei; National Vaccine and Serum Institute (NVSI)
  • Hao Zhang; National Vaccine and Serum Institute (NVSI)
  • Shuai Shao; National Vaccine and Serum Institute (NVSI)
  • Zhao Ming Liu; National Vaccine and Serum Institute (NVSI)
  • Ning Liu; National Vaccine and Serum Institute (NVSI)
  • Xiang Zheng; National Vaccine and Serum Institute (NVSI)
  • Ji Guo Su; National Vaccine and Serum Institute (NVSI)
  • Sen Sen Yang; National Vaccine and Serum Institute (NVSI)
  • Xiang Feng Cong; National Vaccine and Serum Institute (NVSI)
  • Yao Tan; National Vaccine and Serum Institute (NVSI)
  • Wen Wen Lei; National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention (China CDC)
  • Xue Jun Gao; Lanzhou Institute of Biological Products Company Limited
  • Zhi Wei Jiang; Beijing Key Tech Statistical Consulting Co.,Ltd
  • Hui Wang; Beijing Institute of Biological Products Company Limited
  • Meng Li; China National Biotec Group Company Limited
  • Hanadi Mekki Mekki; Union 71, United Arab Emirates
  • Walid Zaher; G42 Healthcare, United Arab Emirates
  • Sally Mahmoud; G42 Healthcare, United Arab Emirates
  • Xue Zhang; China National Biotec Group Company Limited
  • Chang Qu; China National Biotec Group Company Limited
  • Dan Ying Liu; China National Biotec Group Company Limited
  • Jing Zhang; National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention (China CDC)
  • Meng Jie Yang; National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention (China CDC)
  • Islam Eltantawy; G42 Healthcare, United Arab Emirates
  • Peng Xiao; G42 Healthcare, United Arab Emirates
  • Fu Jie Shen; National Vaccine and Serum Institute (NVSI)
  • Jin Juan Wu; National Vaccine and Serum Institute (NVSI)
  • Zi Bo Han; National Vaccine and Serum Institute (NVSI)
  • Li Fang Du; National Vaccine and Serum Institute (NVSI)
  • Fang Tang; National Vaccine and Serum Institute (NVSI)
  • Shi Chen; National Vaccine and Serum Institute (NVSI)
  • Zhi Jing Ma; National Vaccine and Serum Institute (NVSI)
  • Fan Zheng; National Vaccine and Serum Institute (NVSI)
  • Ya Nan Hou; National Vaccine and Serum Institute (NVSI)
  • Xin Yu Li; National Vaccine and Serum Institute (NVSI)
  • Xin Li; National Vaccine and Serum Institute (NVSI)
  • Zhao Nian Wang; China National Biotec Group Company Limited
  • Jin Liang Yin; China National Biotec Group Company Limited
  • Xiao Yan Mao; Lanzhou Institute of Biological Products Company Limited
  • Jin Zhang; Beijing Institute of Biological Products Company Limited
  • Liang Qu; China National Biotec Group Company Limited
  • Yun Tao Zhang; China National Biotec Group Company Limited
  • Xiao Ming Yang; China National Biotec Group Company Limited
  • Guizhen Wu; National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention (China CDC)
  • Qi Ming Li; National Vaccine and Serum Institute (NVSI)
Preprint in English | medRxiv | ID: ppmedrxiv-22279589
ABSTRACT
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 11 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).
Full text: Available Collection: Preprints Database: medRxiv Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines / Variants Language: English Year: 2022 Document Type: Preprint

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Full text: Available Collection: Preprints Database: medRxiv Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines / Variants Language: English Year: 2022 Document Type: Preprint