Early assessment of the safety and immunogenicity of a third dose (booster) of COVID-19 immunization in Chinese adults

Abstract

Inducing durable and effective immunity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) via vaccination is essential to combat the current pandemic of coronavirus disease 2019 (COVID-19). It has been noticed that the strength of anti-COVID-19 vaccination-induced immunity fades over time, which calls for an additional vaccination regime, as known as booster immunization, to restore immunity among previously vaccinated populations. Here we report a pilot open-label trial of a third dose of BBIBP-CorV, an inactivated SARS-CoV-2 vaccine (Vero cell), on 136 participants aged between 18 to 63 years. Safety and immunogenicity in terms of neutralizing antibody titers and cytokine/chemokine responses were analyzed as the main endpoint until day 28. While systemic reactogenicity was either absent or mild, SARS-CoV-2-specific neutralizing antibody titers rapidly arose in all participants within 4 weeks, surpassing the peak antibody titers elicited by the initial two-dose immunization regime. Broad increases of cellular immunity-associated cytokines and chemokines were also detected in the majority of participants after the third vaccination. Furthermore, in an exploratory study, a newly developed recombinant protein vaccine, NVSI-06-08 (CHO Cells), was found to be safe and even more effective than BBIBP-CorV in eliciting humoral immune responses in BBIBP-CorV-primed individuals. Together, these results indicate that a third immunization schedule with either homologous or heterologous vaccine showed favorable safety profiles and restored potent SARS-CoV-2-specific immunity, providing support for further trials of booster vaccination in larger populations.

Keywords

COVID-19 / SARS-CoV-2 / vaccine / immunization / booster immunization

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Acknowledgements

This work was supported by the National Program on Key Research Project of China (Nos. 2020YFA0707500, 2016YFD0500301, 2017YFC0840300, and 2020YFC0842100), National Mega projects of China for Major Infectious Diseases (No. 2016ZX10004001-003), National Mega Projects of China for New Drug Creation (No. 2018ZX09734-004), Beijing Science and Technology Plan (No. Z201100005420014). The National Vaccine and Serum Institute, China National Biotec Group Company Limited; Beijing Institute of Biological Products, China National Biotec Group Company Limited; and China National Biotec Group Company Limited provided the study product and oversaw all trial operations.

Compliance with ethics guidelines

Yuntao Zhang, Yunkai Yang, Xuewei Wang, and Xiaoming Yang are employees of China National Biotec Group Company Limited, Ling Ding and Xiujuan Zhu are employees of Beijing Institute of Biological Products, China National Biotec Group Company Limited, and Yu Liang and Zibo Han are employees of National Vaccine and Serum Institute, China National Biotec Group Company Limited which developed the vaccine and funded the trial. All other authors declare no competing interests. All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2000 (5). Informed consent was obtained from all patients for being included in the study.

Electronic Supplementary Material

ƒSupplementary material is available in the online version of this article at https://doi.org/10.1007/s11684-021-0914-x and is accessible for authorized users.

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