Evidence map›Paper›PMID 32583515›Full record

SynthesisPharmacoepidemiology and drug safety2020

Meta-analysis of the risk of autoimmune thyroiditis, Guillain-Barré syndrome, and inflammatory bowel disease following vaccination with AS04-adjuvanted human papillomavirus 16/18 vaccine.

Dominique Rosillon, Corinne Willame, Fernanda Tavares Da Silva, Adrienne Guignard, Sophie Caterina, Sarah Welby, Frank Struyf

Open access · hybridAbstract readMeta-Analysis
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Pharmacoepidemiology and drug safety, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
0.6field-weighted citation impact, top 31% 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

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 9 citations in OpenAlex.

  1. Risk factors for inflammatory bowel disease: an umbrella review.Frontiers in cellular and infection microbiology · 2024
    Pooled it
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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

7 authors at 1 institution in 1 country.

Dominique RosillonResearch and Development, GSK, Wavre, Belgium.ORCID 0000-0001-7230-1978
Corinne WillameResearch and Development, GSK, Wavre, Belgium.ORCID 0000-0002-6310-6019
Fernanda Tavares Da SilvaResearch and Development, GSK, Wavre, Belgium.
Adrienne GuignardResearch and Development, GSK, Wavre, Belgium.
Sophie CaterinaResearch and Development, GSK, Wavre, Belgium.
Sarah WelbyResearch and Development, GSK, Wavre, Belgium.
Frank StruyfResearch and Development, GSK, Wavre, Belgium.
GlaxoSmithKline (Belgium) · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo assess the risk of three autoimmune diseases - autoimmune thyroiditis (AIT), Guillain-Barré syndrome (GBS), and inflammatory bowel disease (IBD) - in females following AS04-HPV-16/18 vaccination.

methodsThis meta-analysis included data from 18 randomized controlled trials, one cluster-randomized trial, two large observational retrospective cohort studies, and one case-control study. Following vaccination, a risk window of 2 years was defined for AIT and IBD and 42 days for GBS. Odds ratios (ORs) were estimated using three methods: meta-analysis inverse-variance with continuity correction (primary analysis), pooled estimate, and beta-binomial regression.

resultsIn all studies apart from the case-control study, 154 398 exposed and 1 504 322 non-exposed subjects were included, among whom there were 141 and 1972 cases of (autoimmune) thyroiditis; 2 and 2 cases of GBS; and 43 and 401 cases of IBD, respectively. In the case-control study, there were 97 cases of AIT and 13 of GBS; matched with 802 and 130 controls, respectively. The primary analysis OR estimates were 1.46 (95% confidence interval [CI] 1.22-1.76), 11.14 (2.00-61.92), and 1.11 (0.75-1.66) for (autoimmune) thyroiditis, GBS, and IBD, respectively.

conclusionsThis meta-analysis did not show an increased risk of IBD following vaccination with AS04-HPV-16/18. The 1.5-fold increased risk of (autoimmune) thyroiditis does not allow us to conclude about a causal association. For GBS, the very low number of cases and wide 95% CIs negate any firm conclusion.

Indexed as

Adjuvants, ImmunologicCase-Control StudiesCausalityGuillain-Barre SyndromeHumansIncidenceInflammatory Bowel DiseasesObservational Studies as TopicPapillomavirus InfectionsPapillomavirus VaccinesRandomized Controlled Trials as TopicRisk FactorsThyroiditis, AutoimmuneAdjuvants, Immunologichuman papillomavirus vaccine, L1 type 16, 18Papillomavirus Vaccinesautoimmune thyroiditisGuillain-Barré syndromehuman papillomavirus vaccineinflammatory bowel diseasepharmacoepidemiology

Identifiers

PMID32583515
PMCPMC7539912
OpenAlexW3037503959

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.