Evidence map›Paper›PMID 39797410›Full record

ArticleHuman vaccines & immunotherapeutics2025

Immunogenicity and safety of HepE Hecolin® in chronic hepatitis B patients at clinically stable stage: An open-label study in China.

Li Zhang, Qiufen Zhang, Jiaye Liu, Wenlong Wu, Zechun Jiang, Bingyu Yan, Qingfan Cao, Haidong Liu, Huirong Pan, Jingjing Lv and 4 more

Abstract readClinical Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Human vaccines & immunotherapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Li ZhangAcademy of Preventive Medicine, Shandong University, Jinan, China.
Qiufen ZhangDivision of Expanded Program Immunization, Rushan Center for Disease Control and Prevention, Rushan, China.
Jiaye LiuSchool of Public Health, Shenzhen University Medical School, Shenzhen, China.
Wenlong WuShandong Provincial Key Laboratory of Infectious Disease Control and Prevention, Shandong Center for Disease Control and Prevention, Jinan, China.
Zechun JiangDepartment of Medicine, Xiamen Innovax Biotech Co. Ltd, Xiamen, China.
Bingyu YanShandong Provincial Key Laboratory of Infectious Disease Control and Prevention, Shandong Center for Disease Control and Prevention, Jinan, China.
Qingfan CaoDepartment of Medicine, Xiamen Innovax Biotech Co. Ltd, Xiamen, China.
Haidong LiuDepartment of Medicine, Xiamen Innovax Biotech Co. Ltd, Xiamen, China.
Huirong PanDivision of Expanded Program Immunization, Rushan Center for Disease Control and Prevention, Rushan, China.
Jingjing LvShandong Provincial Key Laboratory of Infectious Disease Control and Prevention, Shandong Center for Disease Control and Prevention, Jinan, China.
Yi FengShandong Provincial Key Laboratory of Infectious Disease Control and Prevention, Shandong Center for Disease Control and Prevention, Jinan, China.
Fujie XuCollaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China.
Shoujie HuangState Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Strait Collaborative Innovation Center of Biomedicine and Pharmaceutics, School of Public Health, Global Health Research Center, Duke Kunshan University, Kunshan, China.
Aiqiang XuAcademy of Preventive Medicine, Shandong University, Jinan, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Acute hepatitis E infection could induce severe outcomes among chronic hepatitis B (CHB) patients. Between 2016 and 2017, an open-label study was conducted to evaluate the immunogenicity and safety of hepatitis E vaccine (HepE) in CHB patients, using healthy adults as parallel controls in China. Eligible participants who were aged ≥30 y were enrolled in the study. The CHB group included participants who had ever developed symptoms of hepatitis because of CHB but was currently at a clinically stable stage, which was defined as ALT ≤ 1.5 times of upper limit of the normal range (ULN) in this study. The control group included healthy adults who had hepatitis B surface antigen (HBsAg) negative. HepE was administered for 0, 1, 6 months for all participants. At 1 month after the third-dose vaccination (month 7), the seroconversion rates of anti-HEV IgG were >97% in both groups. The geometric mean concentration (GMC) of anti-HEV IgG in the CHB group was non-inferior to the healthy adult group (0.69 WU/mL, 95% CI 0.55-0.85). The proportion of the participants with adverse events ≥ grade 3 was similar in both groups (

Indexed as

Hepatitis B, ChronicAdultChinaFemaleHepatitis AntibodiesHepatitis B Surface AntigensHepatitis EHumansImmunogenicity, VaccineImmunoglobulin GMaleMiddle AgedSeroconversionVaccines, SyntheticViral Hepatitis VaccineshecolinHepatitis AntibodiesHepatitis B Surface AntigensImmunoglobulin GVaccines, SyntheticViral Hepatitis Vaccineschronic hepatitis BHepatitis E vaccineimmunogenicitysafety

Identifiers

PMID39797410
PMCPMC11730616

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.