Evidence map›Paper›PMID 27694888›Full record

ArticleScientific reports2016

Statistical and Ontological Analysis of Adverse Events Associated with Monovalent and Combination Vaccines against Hepatitis A and B Diseases.

Jiangan Xie, Lili Zhao, Shangbo Zhou, Yongqun He

Open access · goldAbstract read
In one paragraph

Article in Scientific reports, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 14% 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.

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

21 citing papers in PubMed, 1 synthesis or guideline pooled it, 31 citations in OpenAlex.

  1. Pooled it
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  13. Vaccine adverse event enrichment tests.Statistics in medicine · 2021
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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

4 authors at 2 institutions in 2 countries.

Jiangan XieKey Laboratory of Dependable Service Computing in Cyber Physical Society, Ministry of Education, Chongqing University, Chongqing, 400044, China.
Lili ZhaoDepartment of Biostatistics, University of Michigan, Ann Arbor, Michigan, 48109, USA.
Shangbo ZhouKey Laboratory of Dependable Service Computing in Cyber Physical Society, Ministry of Education, Chongqing University, Chongqing, 400044, China.
Yongqun HeUniversity of Michigan Medical School, Ann Arbor, Michigan, 48109, USA.
Chongqing University · CNUniversity of Michigan–Ann Arbor · US

Funding

Ontology-based Information Network to Support Vaccine ResearchR01AI081062 · NIAID · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI HE, YONGQUN · 2009 to 2012
$1.1M
NIAID NIH HHS R01 AI081062
6 · The paper itself

Abstract

Vaccinations often induce various adverse events (AEs), and sometimes serious AEs (SAEs). While many vaccines are used in combination, the effects of vaccine-vaccine interactions (VVIs) on vaccine AEs are rarely studied. In this study, AE profiles induced by hepatitis A vaccine (Havrix), hepatitis B vaccine (Engerix-B), and hepatitis A and B combination vaccine (Twinrix) were studied using the VAERS data. From May 2001 to January 2015, VAERS recorded 941, 3,885, and 1,624 AE case reports where patients aged at least 18 years old were vaccinated with only Havrix, Engerix-B, and Twinrix, respectively. Using these data, our statistical analysis identified 46, 69, and 82 AEs significantly associated with Havrix, Engerix-B, and Twinrix, respectively. Based on the Ontology of Adverse Events (OAE) hierarchical classification, these AEs were enriched in the AEs related to behavioral and neurological conditions, immune system, and investigation results. Twenty-nine AEs were classified as SAEs and mainly related to immune conditions. Using a logistic regression model accompanied with MCMC sampling, 13 AEs (e.g., hepatosplenomegaly) were identified to result from VVI synergistic effects. Classifications of these 13 AEs using OAE and MedDRA hierarchies confirmed the advantages of the OAE-based method over MedDRA in AE term hierarchical analysis.

Indexed as

AdultFemaleHepatitis A VaccinesHepatitis BHepatitis B VaccinesHepatitis CHumansMaleMarkov ChainsMonte Carlo MethodVaccines, CombinedHepatitis A VaccinesHepatitis B VaccinesVaccines, Combined

Identifiers

PMID27694888
PMCPMC5046117
OpenAlexW2529370868

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.