Transient Hepatitis B Surface Antigenemia Following Immunization with Heplisav-B

Mayo Clin Proc Innov Qual Outcomes. 2021 Jan 24;5(3):542-547. doi: 10.1016/j.mayocpiqo.2020.10.010. eCollection 2021 Jun.

Abstract

Objective: To delineate the rate and duration of transient hepatitis B surface antigenemia following Heplisav-B vaccination.

Patients and methods: We retrospectively reviewed the medical records of all adult patients who received Heplisav-B vaccination at our institution from January 1, 2019, through March 31, 2020, and who had hepatitis B surface antigen (HBsAg) testing within 30 days following immunization. Patients with laboratory evidence of prior hepatitis B virus infection or immunization were excluded.

Results: A total of 39 of 1933 patients were tested for HBsAg within 30 days after completing the Heplisav-B vaccination series; of these 39, only 6 (15.4 %) had a positive HBsAg result. Compared with the patients with negative HBsAg results, those with a positive HBsAg result had a significantly lower body mass index (24.8 kg/m2 [interquartile range (IQR), 23 to 26.4 kg/m2] vs 28.6 kg/m2 [IQR, 26.4 to 30.6 kg/m2]; P=.01) and higher prevalence of chronic kidney disease (2 of 6 [33.3%] vs 2 of 33 [6%]; P=.04). The timing of HBsAg testing after completing the vaccination series in the HBsAg-positive group was significantly earlier compared with that of the HBsAg-negative group (2 days [IQR, 0.43 to 2.25 days) vs 12 days [IQR, 10 to 15 days]; P=.0008). Active hepatitis B infection was excluded in all 6 patients. In the HBsAg-positive group, the median time from the date of Heplisav-B administration to a negative HBsAg test result was 17 days (IQR, 8 to 36 days).

Conclusion: As with all conventional hepatitis B vaccines, transient hepatitis B surface antigenemia can be observed with Heplisav-B vaccine, particularly in those with chronic kidney disease and low body mass index.

Keywords: BMI, body mass index; CKD, chronic kidney disease; HBV, hepatitis B virus; HBsAg, hepatitis B surface antigen; IQR, interquartile range; anti-HBc, hepatitis B total core antibody.