A prospective, observational cohort study at Kaiser Permanente Southern California was conducted in which 31,183 adults received at least one dose of HepB-CpG vaccine (Heplisav-B, 2-dose) and 38,442 adults received at least one dose of HepB-alum (Engerix-B, 3-dose) vaccine. The team then followed-up individuals passively through their electronic health records for occurrence of acute myocardial infarction (MI). Weighting and propensity score statistical approaches were used to make sure that the distribution of baseline demographic and clinical characteristics were well-balanced between groups. The analyses found that there was no difference in the rate of acute MI among recipients of HepB-CpG vaccine compared to HepB-alum vaccine.

Although hepatitis B is a vaccine-preventable disease, only 30% of adults have received a 3-dose hepatitis B vaccine series (e.g., HepB-alum). HepB-CpG, a 2-dose hepatitis B vaccine, was licensed in 2017, but because one of the prelicensure clinical trials had found a non-statistically significant higher number of acute MI events in the HepB-CpG group compared to the HepB-alum group, the FDA required that the manufacturer conduct a post-marketing study. Dr. Bruxvoort began this study as part of her post-doctoral fellowship at Kaiser Permanente Southern California, an integrated health care organization that provides insurance and health care to over 4.7 million members.

Results of the study lay to rest concerns about HepB-CpG vaccine and acute MI. Since fewer doses are associated with higher series completion, HepB-CpG vaccine is an important option for increasing hepatitis B vaccine coverage among adults. Publication of this study also coincided with Morbidity and Mortality Weekly Report (MMWR) publication of recommendations from the Advisory Committee on Immunization Practices, which expands the indicated age range for routine hepatitis B vaccination. 

“It is exciting to be involved in a study that was deliberated by the Advisory Committee on Immunization Practices and was considered as part of the CDC MMWR on universal hepatitis B vaccination,” said Dr. Bruxvoort. “The collaboration between UAB and the Department of Research & Evaluation at Kaiser Permanente Southern California, which led this study, is a valued partnership for future research.”