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Safety and immunogenicity of a hybrid-type vaccine booster in BBIBP-CorV recipients in a randomized phase 2 trial

Author

Listed:
  • Nawal Al Kaabi

    (Sheikh Khalifa Medical City, SEHA
    Khalifa University)

  • Yun Kai Yang

    (China National Biotec Group Company Limited)

  • Li Fang Du

    (National Vaccine and Serum Institute (NVSI)
    National Engineering Center for New Vaccine Research)

  • Ke Xu

    (Chinese Center for Disease Control and Prevention (China CDC))

  • Shuai Shao

    (National Vaccine and Serum Institute (NVSI)
    National Engineering Center for New Vaccine Research)

  • Yu Liang

    (National Vaccine and Serum Institute (NVSI)
    National Engineering Center for New Vaccine Research)

  • Yun Kang

    (National Engineering Center for New Vaccine Research
    National Vaccine and Serum Institute (NVSI))

  • Ji Guo Su

    (National Vaccine and Serum Institute (NVSI)
    National Engineering Center for New Vaccine Research)

  • Jing Zhang

    (National Vaccine and Serum Institute (NVSI)
    National Engineering Center for New Vaccine Research)

  • Tian Yang

    (China National Biotec Group Company Limited)

  • Salah Hussein

    (Sheikh Khalifa Medical City, SEHA)

  • Mohamed Saif ElDein

    (Sheikh Khalifa Medical City, SEHA)

  • Sen Sen Yang

    (National Engineering Center for New Vaccine Research
    National Vaccine and Serum Institute (NVSI))

  • Wenwen Lei

    (Chinese Center for Disease Control and Prevention (China CDC))

  • Xue Jun Gao

    (Lanzhou Institute of Biological Products Company Limited)

  • Zhiwei Jiang

    (Beijing Key Tech Statistical Consulting Co., Ltd)

  • Xiangfeng Cong

    (National Engineering Center for New Vaccine Research
    National Vaccine and Serum Institute (NVSI))

  • Yao Tan

    (National Engineering Center for New Vaccine Research
    National Vaccine and Serum Institute (NVSI))

  • Hui Wang

    (Beijing Institute of Biological Products Company Limited)

  • Meng Li

    (China National Biotec Group Company Limited)

  • Hanadi Mekki Mekki

    (Union 71)

  • Walid Zaher

    (G42 Healthcare)

  • Sally Mahmoud

    (G42 Healthcare)

  • 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

    (Chinese Center for Disease Control and Prevention (China CDC))

  • Mengjie Yang

    (Chinese Center for Disease Control and Prevention (China CDC))

  • Islam Eltantawy

    (G42 Healthcare)

  • Jun Wei Hou

    (National Vaccine and Serum Institute (NVSI)
    National Engineering Center for New Vaccine Research)

  • Ze Hua Lei

    (National Vaccine and Serum Institute (NVSI)
    National Engineering Center for New Vaccine Research)

  • Peng Xiao

    (G42 Healthcare)

  • 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

    (Chinese Center for Disease Control and Prevention (China CDC))

  • Qi Ming Li

    (National Vaccine and Serum Institute (NVSI)
    National Engineering Center for New Vaccine Research)

Abstract

NVSI-06-08 is a potential broad-spectrum recombinant COVID-19 vaccine that integrates the antigens from multiple SARS-CoV-2 strains into a single immunogen. Here, we evaluate the safety and immunogenicity of NVSI-06-08 as a heterologous booster dose in BBIBP-CorV recipients in a randomized, double-blind, controlled, phase 2 trial conducted in the United Arab Emirates (NCT05069129). Three groups of healthy adults over 18 years of age (600 participants per group) who have administered two doses of BBIBP-CorV 4-6-month, 7-9-month and >9-month earlier, respectively, are randomized 1:1 to receive either a homologous booster of BBIBP-CorV or a heterologous booster of NVSI-06-08. The incidence of adverse reactions is low, and the overall safety profile is quite similar between two booster regimens. Both Neutralizing and IgG antibodies elicited by NVSI-06-08 booster are significantly higher than those by BBIBP-CorV booster against not only SARS-CoV-2 prototype strain but also multiple variants of concerns (VOCs). Especially, the neutralizing antibody GMT against Omicron variant induced by heterologous NVSI-06-08 booster reaches 367.67, which is substantially greater than that boosted by BBIBP-CorV (GMT: 45.03). In summary, NVSI-06-08 is safe and immunogenic as a booster dose following two doses of BBIBP-CorV, which is immunogenically superior to the homologous boost with another dose of BBIBP-CorV.

Suggested Citation

  • Nawal Al Kaabi & Yun Kai Yang & Li Fang Du & Ke Xu & Shuai Shao & Yu Liang & Yun Kang & Ji Guo Su & Jing Zhang & Tian Yang & Salah Hussein & Mohamed Saif ElDein & Sen Sen Yang & Wenwen Lei & Xue Jun G, 2022. "Safety and immunogenicity of a hybrid-type vaccine booster in BBIBP-CorV recipients in a randomized phase 2 trial," Nature Communications, Nature, vol. 13(1), pages 1-11, December.
    • Handle: RePEc:nat:natcom:v:13:y:2022:i:1:d:10.1038_s41467-022-31379-0
    DOI: 10.1038/s41467-022-31379-0
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    References listed on IDEAS

    as
    1. Sandile Cele & Laurelle Jackson & David S. Khoury & Khadija Khan & Thandeka Moyo-Gwete & Houriiyah Tegally & James Emmanuel San & Deborah Cromer & Cathrine Scheepers & Daniel G. Amoako & Farina Karim , 2022. "Omicron extensively but incompletely escapes Pfizer BNT162b2 neutralization," Nature, Nature, vol. 602(7898), pages 654-656, February.
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    Cited by:

    1. Jie Deng & Yirui Ma & Qiao Liu & Min Du & Min Liu & Jue Liu, 2022. "Comparison of the Effectiveness and Safety of Heterologous Booster Doses with Homologous Booster Doses for SARS-CoV-2 Vaccines: A Systematic Review and Meta-Analysis," IJERPH, MDPI, vol. 19(17), pages 1-17, August.

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