Hepatitis B surface antigenemia following recombinant Engerix B hepatitis B vaccine in an 81-year-old ESRD patient on hemodialysis

Abstract

The first cases of transient hepatitis B surface antigenemia (HBsAg) in adults following hepatitis B virus (HBV) immunization were reported in the 1990s. HBV immunization is mandatory for all hemodialysis (HD) patients. Ly et al. who demonstrated transient HBsAg in eight out of nine HD patients following HBV vaccine concluded that HD patients should not be screened for HBV within a week of HBV immunization and that positive HBsAg within a month of HBV immunization must be interpreted with caution. We present an 81-year-old woman on HD, who needed a booster Recombivax (Merck, Whitehouse Station, NJ, USA) vaccine after remaining hepatitis B surface antibody (HBsAb) negative from previous vaccinations. The HD Unit had switched to Engerix B (GlaxoSmithKline, Atlanta, GA, USA) HBV vaccine. Two days after the first Engerix B vaccine, HBsAg was detected. She was asymptomatic; ALT was 25 U/L. Repeat testing for HBsAg, HBsAb, hepatitis B E antigen (HB E Ag), and hepatitis B DNA (HB DNA), a week later, all returned negative. Previous reports of transient HBsAg following HBV vaccines were after Engerix B vaccination. Our patient is unusual since she had received both brands of HBV vaccines, sequentially, at different times. Twice, HBsAg tests completed as early as 5 days following Recombivax vaccine were negative. We submit that positive HBsAg tests are more likely following Engerix B vaccines. We reemphasize previous recommendations that patients should not be screened for HBsAg < 4 weeks following HBV immunization. This is particularly important in HD units where hepatitis B screening is carried out routinely all year round and hepatitis B vaccinations are commonplace. Very strict schedules must be adopted to avoid false positive HBsAg tests.

Keywords:

• hepatitis B immunization
• hepatitis B surface antigen
• recombinant Engerix B vaccine
• ESRD
• hemodialysis

The first cases of transient hepatitis B surface antigenemia (HBsAg) in adults following hepatitis B vaccination were reported in the 1990s.^1–3 Infection with hepatitis B virus (HBV) can lead to serious long-term complications including chronic active hepatitis, cirrhosis, hepatocellular carcinoma, hepatic failure, and death. Maintenance hemodialysis (HD) exposes end-stage renal disease (ESRD) patients to significantly higher risk of hepatitis B infection, and therefore hepatitis B vaccination is usually mandatory for all HD patients. Ly et al. demonstrated transient HBsAg in 9 of 2400 HD patients with 8 out of 9 (89%) secondary to hepatitis B vaccination and not to active hepatitis B infection.⁴ The authors concluded that HD patients should not be screened for HBV within a week of immunization, and caution should be exercised when interpreting HBsAg seropositivity within 4 weeks of HBV immunization.⁴

An 81-year-old Caucasian woman with a past medical history of hypertension, myeloproliferative disorder with thrombocytosis, on chronic hydroxyurea therapy had been on maintenance HD for ESRD since February 2008. She received her first series of Recombivax (Merck) hepatitis B vaccine on 5 February 2008, 26 March 2008, and 29 August 2008, respectively. Post-vaccination testing demonstrated negative hepatitis B surface antibody (HBsAb). She therefore received the booster dose of the Recombivax hepatitis B vaccine on 28 February 2009. Because she remained negative for HBsAb, there was a need to repeat a new series of hepatitis B vaccinations. At this time, the HD unit had switched to the Engerix B (GlaxoSmithKline) brand of the hepatitis B vaccine. Two days after the first Engerix B vaccine, on 3 September 2009, blood drawn tested positive for HBsAg. Patient remained asymptomatic with normal ALT, 25 U/L. Repeat testing for HBsAg, HBsAb, hepatitis B E antigen (HB E Ag), and hepatitis B DNA (HB DNA), a week later, on 10 September 2009, all returned negative. Clearly, the transient HBsAg, which was gone within a week, was the result of the Engerix B vaccine. Engerix B [hepatitis B vaccine (recombinant)] is a noninfectious recombinant DNA hepatitis B vaccine developed and manufactured by GlaxoSmithKline Biologicals and contains purified surface antigen of the virus obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the HBV.

All previous reports of transient positive HBsAg following hepatitis B vaccination have followed Engerix B administration.^1–5 One previously unreported peculiarity in our patient was that she had earlier received the Recombivax (Merck) vaccine between 2008 and 2009. On two occasions, follow-up HBsAg tests, each drawn 5 days following the Recombivax vaccine, were both negative. We submit that positive transient HBsAg tests are more likely following Engerix B vaccine versus the Recombivax vaccine. More studies are needed in this direction. Moreover, the clinical implications of this difference between the two brands of the vaccine, if any, remain conjectural.

Finally, we wish to reemphasize previous recommendations that patients who receive hepatitis B vaccinations should not be screened for HBsAg < 4 weeks following the hepatitis B vaccination.⁴

Declaration of Interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.