Frontiers in Cellular and Infection Microbiology (Jun 2021)

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

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

DOI
https://doi.org/10.3389/fcimb.2021.672221
Journal volume & issue
Vol. 11

Abstract

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ObjectivesTo compare the safety, immunogenicity, and immune persistence of hepatitis A (HA) vaccines between HBs-Ag-positive and -negative participants.Method9000 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.ConclusionsBoth 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).

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