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.
Adjuvants, Immunologic
/ adverse effects
Case-Control Studies
Causality
Guillain-Barre Syndrome
/ epidemiology
Humans
Incidence
Inflammatory Bowel Diseases
/ epidemiology
Observational Studies as Topic
Papillomavirus Infections
/ prevention & control
Papillomavirus Vaccines
/ adverse effects
Randomized Controlled Trials as Topic
Risk Factors
Thyroiditis, Autoimmune
/ epidemiology
Guillain-Barré syndrome
autoimmune thyroiditis
human papillomavirus vaccine
inflammatory bowel disease
pharmacoepidemiology
Journal
Pharmacoepidemiology and drug safety
ISSN: 1099-1557
Titre abrégé: Pharmacoepidemiol Drug Saf
Pays: England
ID NLM: 9208369
Informations de publication
Date de publication:
09 2020
09 2020
Historique:
received:
02
07
2019
revised:
26
02
2020
accepted:
07
05
2020
pubmed:
26
6
2020
medline:
3
7
2021
entrez:
26
6
2020
Statut:
ppublish
Résumé
To 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. This 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. In 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. This 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.
Identifiants
pubmed: 32583515
doi: 10.1002/pds.5063
pmc: PMC7539912
doi:
Substances chimiques
Adjuvants, Immunologic
0
Papillomavirus Vaccines
0
human papillomavirus vaccine, L1 type 16, 18
0
Types de publication
Journal Article
Meta-Analysis
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1159-1167Informations de copyright
© 2020 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.
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