Immunogenicity and safety of NVSI-06-07 as a heterologous booster after priming with BBIBP-CorV: a phase 2 trial
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Published:2022-06-06
Issue:1
Volume:7
Page:
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ISSN:2059-3635
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Container-title:Signal Transduction and Targeted Therapy
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language:en
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Short-container-title:Sig Transduct Target Ther
Author:
Kaabi Nawal Al, Yang Yun Kai, Zhang Jing, Xu Ke, Liang Yu, Kang Yun, Su Ji Guo, Yang Tian, Hussein Salah, ElDein Mohamed Saif, Shao Shuai, Yang Sen Sen, Lei Wenwen, Gao Xue Jun, Jiang Zhiwei, Wang Hui, Li Meng, Mekki Hanadi Mekki, Zaher Walid, Mahmoud SallyORCID, Zhang Xue, Qu Chang, Liu Dan Ying, Zhang Jing, Yang Mengjie, Eltantawy Islam, Xiao Peng, Wang Zhao Nian, Yin Jin Liang, Mao Xiao Yan, Zhang Jin, Liu Ning, Shen Fu Jie, Qu Liang, Zhang Yun Tao, Yang Xiao MingORCID, Wu Guizhen, Li Qi MingORCID
Abstract
AbstractThe 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.
Funder
Lanzhou Institute of Biological Products Company Limited
Publisher
Springer Science and Business Media LLC
Subject
Cancer Research,Genetics
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