Evidence map›Paper›PMID 34222044›Full record

Trial reportFrontiers in cellular and infection microbiology2021

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 and 8 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IV
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Frontiers in cellular and infection microbiology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02601040 (Phase IV Clinical Trial to Assess the Safety, Immunogenicity,Three-year Immune Persistence of Inactivated Hepatitis A Vaccine), which is not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–field-weighted citation impact, top 90% of its field
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.

NCT02601040 phase4completednot on this map

Phase IV Clinical Trial to Assess the Safety, Immunogenicity,Three-year Immune Persistence of Inactivated Hepatitis A Vaccine (HAV) and Live Attenuated HAV Vaccine in Health Chinese Children and Adult

TypeinterventionalSponsorJiangsu Province Centers for Disease Control and PreventionRan2011 to 2015Enrolled13,500ConditionsHepatitis AArmsAttenuated Hepatitis A Vaccine, H2 Strain, Inactivated Hepatitis A Vaccine, Lu8 Strain, Group A Meningococcal Polysaccharide vaccine
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it, 0 citations in OpenAlex.

  1. Pooled it
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

18 authors at 4 institutions in 1 country.

Xiaodan WangInstitute of Medical Biology, Chinese Academy of Medical Sciences, and Peking Union Medical College, Kunming, China.
Jia LuoInstitute of Medical Biology, Chinese Academy of Medical Sciences, and Peking Union Medical College, Kunming, China.
Fubao MaVaccines and Immunization Department, Jiangsu Provincial Center of Disease Control and Prevention, Nanjing, China.
Guodong KangVaccines and Immunization Department, Jiangsu Provincial Center of Disease Control and Prevention, Nanjing, China.
Zhengrong DingVaccines and Immunization Department, Yunnan Provincial Center of Disease Control and Prevention, Kunming, China.
Yue PanInstitute of Medical Biology, Chinese Academy of Medical Sciences, and Peking Union Medical College, Kunming, China.
Yujiao ZhaoInstitute of Medical Biology, Chinese Academy of Medical Sciences, and Peking Union Medical College, Kunming, China.
Junying ChenInstitute of Medical Biology, Chinese Academy of Medical Sciences, and Peking Union Medical College, Kunming, China.
Kai FengInstitute of Medical Biology, Chinese Academy of Medical Sciences, and Peking Union Medical College, Kunming, China.
Lingmei YanInstitute of Medical Biology, Chinese Academy of Medical Sciences, and Peking Union Medical College, Kunming, China.
Juan ZhangInstitute of Medical Biology, Chinese Academy of Medical Sciences, and Peking Union Medical College, Kunming, China.
Linhao LiInstitute of Medical Biology, Chinese Academy of Medical Sciences, and Peking Union Medical College, Kunming, China.
Qiangping LanInstitute of Medical Biology, Chinese Academy of Medical Sciences, and Peking Union Medical College, Kunming, China.
Daiying LiInstitute of Medical Biology, Chinese Academy of Medical Sciences, and Peking Union Medical College, Kunming, China.
Xiaolei YangInstitute of Medical Biology, Chinese Academy of Medical Sciences, and Peking Union Medical College, Kunming, China.
Guoliang LiInstitute of Medical Biology, Chinese Academy of Medical Sciences, and Peking Union Medical College, Kunming, China.
Jingsi YangInstitute of Medical Biology, Chinese Academy of Medical Sciences, and Peking Union Medical College, Kunming, China.
Qiangming SunInstitute of Medical Biology, Chinese Academy of Medical Sciences, and Peking Union Medical College, Kunming, China.
Chinese Academy of Medical Sciences & Peking Union Medical College · CNJiangsu Provincial Center for Disease Control and Prevention · CNKunming Medical University · CNYunnan Center for Disease Control And Prevention · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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).

Indexed as

Hepatitis A VaccinesSilverHepatitis B AntibodiesHumansImmunization, SecondaryRetrospective StudiesHepatitis A VaccinesHepatitis B AntibodiesSilverhepatitis A vaccineshepatitis B surface antigenimmune persistenceimmunogenicitysafety

Identifiers

PMID34222044
PMCPMC8248179
OpenAlexW3174527778

What OpenQuestion holds

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LicenceCC BY
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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.