Evaluating the Safety in Hepatitis B Vaccines


Investigators examined the profiles of the HepB-CPG vaccine and HepB-alum vaccines to study the onset of select immune-mediated diseases, herpes zoster, or anaphylaxis.

According to a study conducted last year, the number of Americans and foreign born people living in the United States estimated to have chronic hepatitis B is 2.4 million.1

In addition to a large number of people living with the virus, it continues to be a challenging patient group. “They serve as a reservoir of infection for other people, but they also have substantial long-term morbidity including death,” Bradley Ackerson, MD, FAAP, FIDSA, pediatric infectious disease specialist at Kaiser Permanente, Southern California (KPSC), said in an interview.

Ackerson says that while traditionally the transmission was from mother to child, that has subsided greatly and now the majority of cases are amongst adults. And while vaccination can be effective, utility rates for vaccines is low. According to Ackerson, it is only around 30% in adults and only 42% in high-risk adults.

One of the challenges is that people do not get all the required doses. The HepB-alum vaccine (Engerix-B; GlaxoSmithKline), which has been FDA approved for several years, requires 3 doses to be administered over a 6 month period. Some people may choose to start the vaccine process, but do not follow-up for subsequent vaccines. 

A more recent HBV vaccine addition, the HepB-CpG (Heplisav-B; Dynavax), is a 2-shot regimen, and was FDA approved back in 2017.

Ackerson and his coinvestigators wanted to study these two vaccines and the incidence of new-onset immune-mediated diseases, herpes zoster (HZ), and anaphylaxis among vaccine recipients.

The HepB-CpG was administered in 7 of 15 KPSC medical centers while HepB-alum was administered at the other 8 medical centers in a 14 month period between 2018 and 2019. The investigators determined there were 31,183 HepB-CpG and 38,442 HepB-alum recipients given at least one-dose of the vaccine.

“Except for rheumatoid arthritis (RA), all events occurred with similar low frequency in both groups,” Ackerson said.

Ackerson said once they performed chart review to limit the analysis to new-onset RA, the incidence rates for RA were similar among both vaccine groups. And there were no cases of anaphylaxis in the HepB-CpG group.

Ackerson sat down to talk with Contagion to discuss the study’s results in the subsequent poster, “Post-licensure Safety Study of New-onset Immune-mediated Diseases, Herpes Zoster, and Anaphylaxis in Adult Recipients of HepB-CPG Vaccine Versus HepB-alum Vaccine,” that was presented at ID Week.

In talking with Contagion, Ackerson discussed the study’s findings, how it can be applied in clinical practice, and the statistics behind a 2-dose vaccine and a 3-dose vaccine.

1. Wong RJ, Brosgart CL, Welch S, et al. An Updated Assessment of Chronic Hepatitis B Prevalence Among Foreign-Born Persons Living in the United States. Hepatology. 2021;74(2):607-626. doi:10.1002/hep.31782

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