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Hepatitis B vaccine and risk of acute myocardial infarction among individuals with diabetes mellitus
Author(s) -
Wong Katherine,
Bruxvoort Katia,
Slezak Jeff,
Hsu JinWen Y.,
Reynolds Kristi,
Sy Lina S.,
Jacobsen Steven J.
Publication year - 2021
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/pds.5327
Subject(s) - medicine , hepatitis b vaccine , cohort , confidence interval , odds ratio , vaccination , myocardial infarction , pediatrics , immunology , hepatitis b virus , hbsag , virus
Purpose A pre‐licensure clinical trial of a two‐dose cytosine phosphoguanine adjuvanted hepatitis B vaccine (HEPLISAV‐B® [Dynavax, USA]; HepB‐CpG vaccine) found an unanticipated numerical imbalance in acute myocardial infarction (AMI) compared to recipients of a three‐dose aluminum adjuvanted hepatitis B vaccine (ENGERIX‐B® [GlaxoSmithKline, Belgium]; HepB‐alum vaccine). A post‐licensure study was required to compare AMI rates among recipients of HepB‐CpG vaccine and HepB‐alum vaccine. Individuals with diabetes mellitus (DM), who are at higher risk of AMI, comprise more than half of the post‐licensure study cohort. To inform the ongoing post‐licensure study, we examined the association between AMI and receipt of HepB‐alum vaccine in individuals with DM. Methods We conducted a case–control study nested in a cohort of individuals with DM ages ≥40 years at Kaiser Permanente Southern California using electronic health records. AMI cases from 2012 to 2017 were identified by principal discharge diagnosis and matched 1:1 with randomly selected controls. The adjusted odds ratio (aOR) for receipt of ≥1 HepB‐alum vaccine dose was compared for AMI cases and controls using conditional logistic regression. We subsequently performed the same matched case–control analysis stratified by year. Results Of 8138 matched case–control pairs, 17.4% of cases and 15.0% of controls received HepB‐alum vaccine. The aOR of HepB‐alum vaccination comparing cases and controls was 0.97 (95% confidence interval 0.87–1.08). Similarly, there was no significant association between HepB‐alum vaccine and AMI in any of the study years. Conclusions HepB‐alum vaccination was not associated with AMI in individuals with DM. This finding will provide contextual insight for the ongoing post‐licensure study of HepB‐CpG vaccine.