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

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 subj...

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Main Authors: 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
Format: Article
Language:English
Published: Frontiers Media S.A. 2021-06-01
Series:Frontiers in Cellular and Infection Microbiology
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fcimb.2021.672221/full
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author 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
author_facet 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
author_sort Xiaodan Wang
collection DOAJ
description 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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spelling doaj.art-3d0aac2d02ff42f089f46607ac7cf2d92022-12-21T17:34:17ZengFrontiers Media S.A.Frontiers in Cellular and Infection Microbiology2235-29882021-06-011110.3389/fcimb.2021.672221672221The Safety, Immunogenicity, and Immunopersistence of Hepatitis A Vaccine in HBs-Ag-Positive Participants: A Retrospective StudyXiaodan Wang0Xiaodan Wang1Xiaodan Wang2Jia Luo3Jia Luo4Jia Luo5Fubao Ma6Guodong Kang7Zhengrong Ding8Yue Pan9Yue Pan10Yue Pan11Yujiao Zhao12Yujiao Zhao13Yujiao Zhao14Junying Chen15Junying Chen16Junying Chen17Kai Feng18Kai Feng19Kai Feng20Lingmei Yan21Lingmei Yan22Lingmei Yan23Juan Zhang24Juan Zhang25Juan Zhang26Juan Zhang27Linhao Li28Linhao Li29Linhao Li30Linhao Li31Qiangping Lan32Qiangping Lan33Qiangping Lan34Daiying Li35Daiying Li36Daiying Li37Xiaolei Yang38Xiaolei Yang39Xiaolei Yang40Guoliang Li41Guoliang Li42Guoliang Li43Jingsi Yang44Jingsi Yang45Jingsi Yang46Qiangming Sun47Qiangming Sun48Qiangming Sun49Institute of Medical Biology, Chinese Academy of Medical Sciences, and Peking Union Medical College, Kunming, ChinaYunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Diseases, Kunming, ChinaYunnan Provincial Key Laboratory of Vector-borne Diseases Control and Research, Kunming, ChinaInstitute of Medical Biology, Chinese Academy of Medical Sciences, and Peking Union Medical College, Kunming, ChinaYunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Diseases, Kunming, ChinaYunnan Provincial Key Laboratory of Vector-borne Diseases Control and Research, Kunming, ChinaVaccines and Immunization Department, Jiangsu Provincial Center of Disease Control and Prevention, Nanjing, ChinaVaccines and Immunization Department, Jiangsu Provincial Center of Disease Control and Prevention, Nanjing, ChinaVaccines and Immunization Department, Yunnan Provincial Center of Disease Control and Prevention, Kunming, ChinaInstitute of Medical Biology, Chinese Academy of Medical Sciences, and Peking Union Medical College, Kunming, ChinaYunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Diseases, Kunming, ChinaYunnan Provincial Key Laboratory of Vector-borne Diseases Control and Research, Kunming, ChinaInstitute of Medical Biology, Chinese Academy of Medical Sciences, and Peking Union Medical College, Kunming, ChinaYunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Diseases, Kunming, ChinaYunnan Provincial Key Laboratory of Vector-borne Diseases Control and Research, Kunming, ChinaInstitute of Medical Biology, Chinese Academy of Medical Sciences, and Peking Union Medical College, Kunming, ChinaYunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Diseases, Kunming, ChinaYunnan Provincial Key Laboratory of Vector-borne Diseases Control and Research, Kunming, ChinaInstitute of Medical Biology, Chinese Academy of Medical Sciences, and Peking Union Medical College, Kunming, ChinaYunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Diseases, Kunming, ChinaYunnan Provincial Key Laboratory of Vector-borne Diseases Control and Research, Kunming, ChinaInstitute of Medical Biology, Chinese Academy of Medical Sciences, and Peking Union Medical College, Kunming, ChinaYunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Diseases, Kunming, ChinaYunnan Provincial Key Laboratory of Vector-borne Diseases Control and Research, Kunming, ChinaInstitute of Medical Biology, Chinese Academy of Medical Sciences, and Peking Union Medical College, Kunming, ChinaYunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Diseases, Kunming, ChinaYunnan Provincial Key Laboratory of Vector-borne Diseases Control and Research, Kunming, ChinaSchool of Basic Medicine, Kunming Medical University, Kunming, ChinaInstitute of Medical Biology, Chinese Academy of Medical Sciences, and Peking Union Medical College, Kunming, ChinaYunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Diseases, Kunming, ChinaYunnan Provincial Key Laboratory of Vector-borne Diseases Control and Research, Kunming, ChinaSchool of Basic Medicine, Kunming Medical University, Kunming, ChinaInstitute of Medical Biology, Chinese Academy of Medical Sciences, and Peking Union Medical College, Kunming, ChinaYunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Diseases, Kunming, ChinaYunnan Provincial Key Laboratory of Vector-borne Diseases Control and Research, Kunming, ChinaInstitute of Medical Biology, Chinese Academy of Medical Sciences, and Peking Union Medical College, Kunming, ChinaYunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Diseases, Kunming, ChinaYunnan Provincial Key Laboratory of Vector-borne Diseases Control and Research, Kunming, ChinaInstitute of Medical Biology, Chinese Academy of Medical Sciences, and Peking Union Medical College, Kunming, ChinaYunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Diseases, Kunming, ChinaYunnan Provincial Key Laboratory of Vector-borne Diseases Control and Research, Kunming, ChinaInstitute of Medical Biology, Chinese Academy of Medical Sciences, and Peking Union Medical College, Kunming, ChinaYunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Diseases, Kunming, ChinaYunnan Provincial Key Laboratory of Vector-borne Diseases Control and Research, Kunming, ChinaInstitute of Medical Biology, Chinese Academy of Medical Sciences, and Peking Union Medical College, Kunming, ChinaYunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Diseases, Kunming, ChinaYunnan Provincial Key Laboratory of Vector-borne Diseases Control and Research, Kunming, ChinaInstitute of Medical Biology, Chinese Academy of Medical Sciences, and Peking Union Medical College, Kunming, ChinaYunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Diseases, Kunming, ChinaYunnan Provincial Key Laboratory of Vector-borne Diseases Control and Research, Kunming, ChinaObjectivesTo 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).https://www.frontiersin.org/articles/10.3389/fcimb.2021.672221/fullhepatitis A vaccinesimmunogenicityimmune persistencehepatitis B surface antigensafety
spellingShingle 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
The Safety, Immunogenicity, and Immunopersistence of Hepatitis A Vaccine in HBs-Ag-Positive Participants: A Retrospective Study
Frontiers in Cellular and Infection Microbiology
hepatitis A vaccines
immunogenicity
immune persistence
hepatitis B surface antigen
safety
title The Safety, Immunogenicity, and Immunopersistence of Hepatitis A Vaccine in HBs-Ag-Positive Participants: A Retrospective Study
title_full The Safety, Immunogenicity, and Immunopersistence of Hepatitis A Vaccine in HBs-Ag-Positive Participants: A Retrospective Study
title_fullStr The Safety, Immunogenicity, and Immunopersistence of Hepatitis A Vaccine in HBs-Ag-Positive Participants: A Retrospective Study
title_full_unstemmed The Safety, Immunogenicity, and Immunopersistence of Hepatitis A Vaccine in HBs-Ag-Positive Participants: A Retrospective Study
title_short The Safety, Immunogenicity, and Immunopersistence of Hepatitis A Vaccine in HBs-Ag-Positive Participants: A Retrospective Study
title_sort safety immunogenicity and immunopersistence of hepatitis a vaccine in hbs ag positive participants a retrospective study
topic hepatitis A vaccines
immunogenicity
immune persistence
hepatitis B surface antigen
safety
url https://www.frontiersin.org/articles/10.3389/fcimb.2021.672221/full
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