PMID- 37266421 OWN - NLM STAT- MEDLINE DCOM- 20230605 LR - 20230606 IS - 1664-3224 (Electronic) IS - 1664-3224 (Linking) VI - 14 DP - 2023 TI - Antibody response and safety of inactivated SARS-CoV-2 vaccines in chronic hepatitis B patients with and without cirrhosis. PG - 1167533 LID - 10.3389/fimmu.2023.1167533 [doi] LID - 1167533 AB - BACKGROUND: The immune response and safety of inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines among patients with chronic hepatitis B (CHB), especially those with cirrhosis, are not clear. Therefore, this study was conducted to evaluate the efficacy and safety of inactivated SARS-CoV-2 vaccines among CHB patients with and without cirrhosis. PATIENTS AND METHODS: A total of 643 CHB patients who received two doses of inactivated SARS-CoV-2 vaccines (BBIBP-CorV and CoronaVac) were enrolled. Serum samples were collected and tested for SARS-CoV-2 S-receptor-binding domain (S-RBD) immunoglobulin G (IgG) at enrollment. Data on adverse events (AEs) within 7 days after the second dose were obtained using a questionnaire. RESULTS: A total of 416 non-cirrhotic and 227 cirrhotic patients were included in the analysis. Cirrhotic patients had lower antibody titers than non-cirrhotic patients after adjusting for age, sex, and time interval (2.45 vs. 2.60 ng/ml, p = 0.034). Furthermore, the study revealed that cirrhotic patients demonstrated a slower rate of seropositivity increase, with the highest rate being recorded at week 4 and reaching 94.7%. On the other hand, among non-cirrhotic patients, the seropositivity rate peak was observed at week 2 and reached 96.0%. In addition, cirrhotic patients displayed a more rapid decline in the seropositivity rate, dropping to 54.5% after >/=16 weeks, while non-cirrhotic patients exhibited a decrease to 67.2% after the same time period. The overall incidence of AEs was low (18.4%), and all AEs were mild and self-limiting. In addition, 16.0% of participants had mild liver function abnormalities, and half of them returned to normality within the next 6 months without additional therapy. The participants who experienced liver function abnormalities showed a higher seropositivity rate and antibody titer than those who did not (91.6% vs. 79.5%, p = 0.005; 2.73 vs. 2.41 ng/ml, p < 0.001). CONCLUSION: Cirrhotic CHB patients had lower antibody titers to inactivated SARS-CoV-2 vaccines than non-cirrhotic patients. The vaccines were generally well tolerated in both non-cirrhotic and cirrhotic CHB patient groups. Patients with abnormal liver function may have a better antibody response than those without. CI - Copyright (c) 2023 Cao, Huang, Zhong, Liao, Tan, Zhao, Guo and Fan. FAU - Cao, Huanhuan AU - Cao H AD - Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Nanfang Hospital, Southern Medical University, Guangzhou, China. AD - Guangdong Provincial Clinical Research Center for Viral Hepatitis, Nanfang Hospital, Southern Medical University, Guangzhou, China. AD - Key Laboratory of Infectious Diseases Research in South China, Ministry of Education, Nanfang Hospital, Southern Medical University, Guangzhou, China. AD - Department of Infectious Diseases, Nanfang Hospital, Southern Medical University, Guangzhou, China. AD - Department of Infectious Diseases, Affiliated Dongguan People's Hospital, Southern Medical University, Dongguan, China. FAU - Huang, Yufei AU - Huang Y AD - Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Nanfang Hospital, Southern Medical University, Guangzhou, China. AD - Guangdong Provincial Clinical Research Center for Viral Hepatitis, Nanfang Hospital, Southern Medical University, Guangzhou, China. AD - Key Laboratory of Infectious Diseases Research in South China, Ministry of Education, Nanfang Hospital, Southern Medical University, Guangzhou, China. AD - Department of Infectious Diseases, Nanfang Hospital, Southern Medical University, Guangzhou, China. FAU - Zhong, Chunxiu AU - Zhong C AD - Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Nanfang Hospital, Southern Medical University, Guangzhou, China. AD - Guangdong Provincial Clinical Research Center for Viral Hepatitis, Nanfang Hospital, Southern Medical University, Guangzhou, China. AD - Key Laboratory of Infectious Diseases Research in South China, Ministry of Education, Nanfang Hospital, Southern Medical University, Guangzhou, China. AD - Department of Infectious Diseases, Nanfang Hospital, Southern Medical University, Guangzhou, China. FAU - Liao, Xingmei AU - Liao X AD - Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Nanfang Hospital, Southern Medical University, Guangzhou, China. AD - Guangdong Provincial Clinical Research Center for Viral Hepatitis, Nanfang Hospital, Southern Medical University, Guangzhou, China. AD - Key Laboratory of Infectious Diseases Research in South China, Ministry of Education, Nanfang Hospital, Southern Medical University, Guangzhou, China. AD - Department of Infectious Diseases, Nanfang Hospital, Southern Medical University, Guangzhou, China. FAU - Tan, Wenjuan AU - Tan W AD - Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Nanfang Hospital, Southern Medical University, Guangzhou, China. AD - Guangdong Provincial Clinical Research Center for Viral Hepatitis, Nanfang Hospital, Southern Medical University, Guangzhou, China. AD - Key Laboratory of Infectious Diseases Research in South China, Ministry of Education, Nanfang Hospital, Southern Medical University, Guangzhou, China. AD - Department of Infectious Diseases, Nanfang Hospital, Southern Medical University, Guangzhou, China. FAU - Zhao, Siru AU - Zhao S AD - Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Nanfang Hospital, Southern Medical University, Guangzhou, China. AD - Guangdong Provincial Clinical Research Center for Viral Hepatitis, Nanfang Hospital, Southern Medical University, Guangzhou, China. AD - Key Laboratory of Infectious Diseases Research in South China, Ministry of Education, Nanfang Hospital, Southern Medical University, Guangzhou, China. AD - Department of Infectious Diseases, Nanfang Hospital, Southern Medical University, Guangzhou, China. FAU - Guo, Liangxu AU - Guo L AD - Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Nanfang Hospital, Southern Medical University, Guangzhou, China. AD - Guangdong Provincial Clinical Research Center for Viral Hepatitis, Nanfang Hospital, Southern Medical University, Guangzhou, China. AD - Key Laboratory of Infectious Diseases Research in South China, Ministry of Education, Nanfang Hospital, Southern Medical University, Guangzhou, China. AD - Department of Infectious Diseases, Nanfang Hospital, Southern Medical University, Guangzhou, China. FAU - Fan, Rong AU - Fan R AD - Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Nanfang Hospital, Southern Medical University, Guangzhou, China. AD - Guangdong Provincial Clinical Research Center for Viral Hepatitis, Nanfang Hospital, Southern Medical University, Guangzhou, China. AD - Key Laboratory of Infectious Diseases Research in South China, Ministry of Education, Nanfang Hospital, Southern Medical University, Guangzhou, China. AD - Department of Infectious Diseases, Nanfang Hospital, Southern Medical University, Guangzhou, China. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20230517 PL - Switzerland TA - Front Immunol JT - Frontiers in immunology JID - 101560960 RN - 0 (BIBP COVID-19 vaccine) RN - 0 (COVID-19 Vaccines) RN - 0 (sinovac COVID-19 vaccine) SB - IM MH - Humans MH - Antibody Formation MH - *COVID-19/prevention & control MH - COVID-19 Vaccines/adverse effects MH - *Hepatitis B, Chronic/complications MH - Liver Cirrhosis MH - SARS-CoV-2 MH - Male MH - Female PMC - PMC10230951 OTO - NOTNLM OT - SARS-CoV-2 vaccine OT - chronic hepatitis B OT - cirrhosis OT - immunogenicity OT - liver injury OT - safety COIS- The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. EDAT- 2023/06/02 13:16 MHDA- 2023/06/05 06:42 PMCR- 2023/05/17 CRDT- 2023/06/02 10:59 PHST- 2023/02/20 00:00 [received] PHST- 2023/05/02 00:00 [accepted] PHST- 2023/06/05 06:42 [medline] PHST- 2023/06/02 13:16 [pubmed] PHST- 2023/06/02 10:59 [entrez] PHST- 2023/05/17 00:00 [pmc-release] AID - 10.3389/fimmu.2023.1167533 [doi] PST - epublish SO - Front Immunol. 2023 May 17;14:1167533. doi: 10.3389/fimmu.2023.1167533. eCollection 2023.