The Safety, Immunogenicity, and Immunopersistence of Hepatitis A Vaccine in HBs-Ag-Positive Participants: A Retrospective Study

Xiaodan Wang, Jia Luo, Fubao Ma, Guodong Kang, Zhengrong Ding, Yue Pan, Yujiao Zhao, Junying Chen, Kai Feng, Lingmei Yan, Juan Zhang, Linhao Li, Qiangping Lan, Daiying Li, Xiaolei Yang, Guoliang Li, Jingsi Yang, Qiangming Sun, Xiaodan Wang, Jia Luo, Fubao Ma, Guodong Kang, Zhengrong Ding, Yue Pan, Yujiao Zhao, Junying Chen, Kai Feng, Lingmei Yan, Juan Zhang, Linhao Li, Qiangping Lan, Daiying Li, Xiaolei Yang, Guoliang Li, Jingsi Yang, Qiangming Sun

Abstract

Objectives: To compare the safety, immunogenicity, and immune persistence of hepatitis A (HA) vaccines between HBs-Ag-positive and -negative participants.

Method: 9000 participants were enrolled in the phase IV study of live attenuated HA (HA-L) or inactivated HA (HA-I) vaccines. The HBs-Ag-positive subjects were detected and became an independent observation group. Adverse reactions (ARs), geometric mean concentrations (GMCs) and seroconversion rates (SRs) of the vaccines were analyzed at five time points until three years after vaccination. Results: 120 HBs-Ag-positive subjects were screened out, only 1 participant had grade 1 experienced ARs after HA-L injection. Except the time point of two years, the SRs of HBs-Ag-positive group were 100% for both vaccines. The GMCs were not statistically different between HBs-Ag-positive and -negative groups after the HA-L vaccination. The logarithmically transformed GMCs for HBs-Ag-positive and -negative groups were 3.21 mIU/mL (95% CI, 2.03-4.39 mIU/mL) and 2.95 mIU/mL (95% CI, 2.88-3.02 mIU/mL) 28 days after the HA-L vaccination, respectively.

Conclusions: Both HA-L and HA-I vaccines were safe for HBs-Ag-positive participants and may provide an excellent long-term protection against HAV in this study. The results indicated that people positive or negative for HBs-Ag can receive both HA-L and HA-I vaccines (ClinicalTrials.gov number, NCT02601040).

Keywords: hepatitis A vaccines; hepatitis B surface antigen; immune persistence; immunogenicity; safety.

Conflict of interest statement

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.

Copyright © 2021 Wang, Luo, Ma, Kang, Ding, Pan, Zhao, Chen, Feng, Yan, Zhang, Li, Lan, Li, Yang, Li, Yang and Sun.

Figures

Figure 1
Figure 1
The research strategy of this study.
Figure 2
Figure 2
Analysis of characteristics of HBs-Ag-positive participants. (A) The proportion of HBs-Ag-positive participants in all participants to be tested. (B) The age distribution in HBs-Ag-positive participants. (C) The proportion of males and females in HBs-Ag-positive participants. (D) The proportion of males and females in all participants to be tested.
Figure 3
Figure 3
The values of anti-HAV IgG titer in HBs-Ag-positive or -negative participants of HA-L and HA-I groups.

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