Evidence map›Paper›PMID 39962038›Full record

Trial reportNature communications2025

Effectiveness of a hepatitis E vaccine against medically-attended symptomatic infection in HBsAg-positive adults from a test-negative design study.

Chunlan Zhuang, Xiaohui Liu, Xingcheng Huang, Jiaoxi Lu, Kongxin Zhu, Mengjun Liao, Lu Chen, Hanmin Jiang, Xia Zang, Yijun Wang and 10 more

Registry-linked trialAbstract readClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nature communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01014845 (A Phase 3, Randomized, Double-blind, Placebo), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

NCT01014845 phase3completednot on this map

A Phase 3, Randomized, Double-blind, Placebo (Hepatitis B Vaccine) Controlled Clinical Trial of Recombinant (E. Coli) Hepatitis E Vaccine

TypeinterventionalSponsorXiamen UniversityRan2007 to 2017Enrolled112,604ConditionsHepatitis EArmshepatitis E vaccine, Hepatitis B vaccine
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Review
  3. Traveling with chronic viral hepatitis.Tropical diseases, travel medicine and vaccines · 2026
    Review
  4. Review
  5. Article
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

20 authors.

Chunlan Zhuang *State Key Laboratory of Vaccines for Infectious Diseases, Xiang An Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen, China.
Xiaohui Liu *State Key Laboratory of Vaccines for Infectious Diseases, Xiang An Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen, China.ORCID http://orcid.org/0000-0003-1828-0162
Xingcheng HuangState Key Laboratory of Vaccines for Infectious Diseases, Xiang An Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen, China.ORCID http://orcid.org/0000-0002-0322-1330
Jiaoxi LuState Key Laboratory of Vaccines for Infectious Diseases, Xiang An Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen, China.
Kongxin ZhuState Key Laboratory of Vaccines for Infectious Diseases, Xiang An Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen, China.
Mengjun LiaoState Key Laboratory of Vaccines for Infectious Diseases, Xiang An Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen, China.
Lu ChenState Key Laboratory of Vaccines for Infectious Diseases, Xiang An Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen, China.
Hanmin JiangDongtai Centre for Disease Control and Prevention, Yancheng, Jiangsu, China.
Xia ZangDongtai Centre for Disease Control and Prevention, Yancheng, Jiangsu, China.
Yijun WangDongtai Centre for Disease Control and Prevention, Yancheng, Jiangsu, China.
Changlin YangDongtai Centre for Disease Control and Prevention, Yancheng, Jiangsu, China.
Donglin LiuDongtai Centre for Disease Control and Prevention, Yancheng, Jiangsu, China.
Zizheng ZhengState Key Laboratory of Vaccines for Infectious Diseases, Xiang An Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen, China.ORCID http://orcid.org/0000-0003-0099-4212
Xuefeng ZhangJiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.
Shoujie HuangState Key Laboratory of Vaccines for Infectious Diseases, Xiang An Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen, China.
Yue HuangState Key Laboratory of Vaccines for Infectious Diseases, Xiang An Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen, China. huangyuesph@xmu.edu.cn.
Yingying SuState Key Laboratory of Vaccines for Infectious Diseases, Xiang An Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen, China. yingyingsu@xmu.edu.cn.
Ting WuState Key Laboratory of Vaccines for Infectious Diseases, Xiang An Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen, China.
Jun ZhangState Key Laboratory of Vaccines for Infectious Diseases, Xiang An Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen, China. zhangj@xmu.edu.cn.ORCID http://orcid.org/0000-0002-6601-9180
Ningshao XiaState Key Laboratory of Vaccines for Infectious Diseases, Xiang An Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen, China.ORCID http://orcid.org/0000-0003-0179-5266

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The effectiveness of the hepatitis E vaccine in high-risk groups, such as chronic hepatitis B (CHB) patients, remains understudied. A key clinical manifestation of CHB is the persistent positivity of hepatitis B surface antigen (HBsAg). We conducted a test-negative design study involving 2,926 HBsAg-positive individuals (born 1941-1991; median age 49.0; male-to-female ratio of 1.4), identified through a hepatitis surveillance system, as part of the phase 3 trial (NCT01014845) of the recombinant hepatitis E vaccine HEV 239 (Hecolin). This system monitored suspected hepatitis cases and performed diagnoses across 11 townships in Dongtai, Jiangsu, China, from 2007 to 2017. Vaccine effectiveness of HEV 239 was assessed by comparing vaccination status between confirmed 96 hepatitis E cases and 2830 test-negative controls, using logistic regression adjusted for sex and age. We found that HEV 239 vaccination was associated with a reduced risk of hepatitis E among HBsAg-positive individuals, with an estimated effectiveness of 72.1% [95% confidence interval (CI) 11.2-91.2], and 81.5% (95% CI 35.9-94.6) among phase 3 trial participants. Our findings show that HEV 239 is highly effective in HBsAg-positive adults, supporting its future recommended use in this population.

Indexed as

Hepatitis B Surface AntigensHepatitis EHepatitis E virusVaccine EfficacyViral Hepatitis VaccinesAdultAgedChinaFemaleHepatitis B, ChronicHumansMaleMiddle AgedVaccinationVaccines, SynthetichecolinHepatitis B Surface AntigensVaccines, SyntheticViral Hepatitis Vaccines

Identifiers

PMID39962038
PMCPMC11832733

What OpenQuestion holds

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Registered trials

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.