Safety and antibody response to inactivated COVID-19 vaccine in patients with chronic hepatitis B virus infection

慢性乙型肝炎病毒感染患者对灭活 COVID-19 疫苗的安全性和抗体反应

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作者:Taiyu He, Yingzhi Zhou, Pan Xu, Ning Ling, Min Chen, Tianquan Huang, Biqiong Zhang, Ziqiao Yang, Ling Ao, Hu Li, Zhiwei Chen, Dazhi Zhang, Xiaofeng Shi, Yu Lei, Zhiyi Wang, Weiqun Zeng, Peng Hu, Yinghua Lan, Zhi Zhou, Juan Kang, Ying Huang, Tongdong Shi, Qingbo Pan, Qian Zhu, Xiping Ran, Yingzhi Zha

Aims

The safety and antibody responses of coronavirus disease 2019 (COVID-19) vaccination in patients with chronic hepatitis B (CHB) virus infection is still unclear, and exploration in safety and antibody responses of COVID-19 vaccination in CHB patients is significant in clinical practice.

Background and aims

The safety and antibody responses of coronavirus disease 2019 (COVID-19) vaccination in patients with chronic hepatitis B (CHB) virus infection is still unclear, and exploration in safety and antibody responses of COVID-19 vaccination in CHB patients is significant in clinical practice.

Conclusions

Inactivated COVID-19 vaccines were well tolerated, and induced effective antibody response against SARS-CoV-2 in CHB patients.

Methods

362 adult CHB patients and 87 healthy controls at an interval of at least 21 days after a full-course vaccination (21-105 days) were enrolled. Adverse events (AEs) were collected by questionnaire. The antibody profiles at 1, 2 and 3 months were elucidated by determination of anti-spike IgG, anti-receptor-binding domain (RBD) IgG, and RBD-angiotensin-converting enzyme 2 blocking antibody. SARS-CoV-2 specific B cells were also analysed.

Results

All AEs were mild and self-limiting, and the incidence was similar between CHB patients and controls. Seropositivity rates of three antibodies were similar between CHB patients and healthy controls at 1, 2 and 3 months, but CHB patients had lower titers of three antibodies at 1 month. Compared to healthy controls, HBeAg-positive CHB patients had higher titers of three antibodies at 3 months (all P < .05) and a slower decline in antibody titers. Frequency of RBD-specific B cells was positively correlated with titers of anti-RBD IgG (OR = 1.067, P = .004), while liver cirrhosis, antiviral treatment, levels of HBV DNA, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and total bilirubin (TB) were not correlated with titers of anti-RBD IgG. Conclusions: Inactivated COVID-19 vaccines were well tolerated, and induced effective antibody response against SARS-CoV-2 in CHB patients.

Trial registration

ClinicalTrials.gov NCT05007665.

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