For a study, researchers sought to compare the incidence of acute MI among recipients of the HepB-CpG vaccination and the HepB-alum vaccine. The Kaiser Permanente Southern California (KPSC) integrated health care organization with 15 medical sites and nearly 4.7 million members undertook the prospective cohort noninferiority trial. From August 7, 2018, to October 31, 2019, 69,625 people who were not on dialysis got at least one dose of a hepatitis B vaccination in either the family medicine or internal medicine departments at KPSC (November 30, 2020, final follow-up). Individuals were monitored for the incidence of type 1 acute MI for 13 months following the index dosage. Using diagnostic codes, potential events were discovered and judged by cardiologists. The adjusted hazard ratio (HR) of acute MI was calculated by comparing HepB-CpG vaccination receivers with HepB-alum vaccine recipients, using inverse probability of treatment weighting (IPTW) to account for demographic and clinical features. The upper limit of the 1-sided 97.5% CI was compared to a noninferiority margin of two.
About 51.2% (n=15,965) of the 31,183 HepB-CpG vaccination recipients (median age, 49 years; IQR, 38-56 years) were men, and 52.7% (n=16,423) were Hispanic. Around 50.8% (19,533) of the 38,442 HepB-alum recipients (median age, 49 years; IQR, 39-56 years) were men, and 47.1% (n=18,125) were Hispanic. After IPTW, the characteristics of the vaccination groups were well balanced. 52 type 1 acute MI events were confirmed among HepB-CpG vaccine recipients at a rate of 1.67 per 1,000 person-years, and 71 types 1 acute MI events were confirmed among HepB-alum vaccine recipients at a rate of 1.86 per 1,000 person-years (absolute rate difference, 0.19 [95% CI, 0.82 to 0.44]; adjusted HR, 0.92 [1-sided 97.5% CI∞ to 1.32], which was below the noninferiority margin; P<.001 for noninferiority). Receiving HepB-CpG vaccination vs HepB-alum vaccine did not fulfill the statistical threshold for increased risk of acute myocardial infarction in this cohort research.
Reference:jamanetwork.com/journals/jama/fullarticle/2790492
