The overall prevalence of chronic hepatitis B infection (HBV) in the United States is estimated to be around 1.59 million. That is especially concerning because chronic HBV can develop into a serious disease, resulting in long-term health problems, including liver damage, liver failure, liver cancer, and even death.
In 2017, the first new hepatitis B vaccine in the U.S. in more than 25 years was approved, becoming the only two-dose hepatitis B vaccine available for adults. The FDA approved HEPLISAV-B (Hepatitis B Vaccine, Recombinant [Adjuvanted]) for prevention of infection caused by all known subtypes of hepatitis B virus in adults aged 18 years and older.
More recently, a postmarketing study assessed the rates of occurrence of AMI in recipients of HEPLISAV-B, compared with the older HBV vaccine, Engerix-B. The results were selected for an oral presentation at the National Foundation for Infectious Diseases 2021 Annual Conference on Vaccinology Research this spring.
Included in the postmarketing observational, noninferiority surveillance study (HBV-25) were 31,000 patients who received HEPLISAV-B and about 38,000 patients who received Engerix-B. Results indicated that the AMI rate per 1,000 person-years was 1.67 for HEPLISAV-B and 1.86 for Engerix-B.
Researchers from Kaiser Permanente's Southern California Center for Vaccine Safety and Effectiveness found that the hazard ratio comparing the rate of AMI in the HEPLISAV-B group with the Engerix-B group was 0.92, with a 95% confidence interval of 0.63 to 1.32.
"The upper bound of the 95% confidence interval of the hazard ratio comparing the rate of AMI in the HEPLISAV-B group to the Engerix-B group was less than 2.0, meeting the primary endpoint. Thus, these results provide evidence there is no increased risk of AMI associated with vaccination with HEPLISAV-B compared to Engerix-B," according to the authors.
"These results reinforce our previous clinical data regarding the safety of HEPLISAV-B and support our confidence in its ability to prevent hepatitis B infection in adults," added Robert Janssen, MD, chief medical officer of the manufacturer Dynavax Technology's chief medical officer.
A study in July published in Pharmacoepidemiology and Drug Safety noted that the pre-licensure clinical trial of HEPLISAV-B found an unanticipated numerical imbalance in AMI to recipients of Engerix-B, the three-dose; HepB-alum vaccine.
Kaiser Permanente authors advised that a postlicensure study was required to compare AMI rates among recipients of HepB-CpG vaccine, marketed as HEPLISAV-B, and HepB-alum vaccine. Diabetes mellitus patients, who are at higher risk of AMI, made up more than half of the postlicensure 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," the researchers wrote.
The case-control study of DM patients aged 40 years and older at Kaiser Permanente Southern California used electronic health records. Investigators identified AMI cases from 2012 to 2017 by principal discharge diagnosis and matched 1:1 with randomly selected controls. The study team subsequently performed the same matched case-control analysis stratified by year.
Ultimately, of 8,138 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 0.87Ð1.08)," the study noted. "Similarly, there was no significant association between HepB-alum vaccine and AMI in any of the study years."
"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," the authors concluded.
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