Efficacy of High-Dose Intra-dermal Hepatitis B Virus Vaccine in Previous Vaccination Non-responders with Chronic Liver Disease

Abstract

Hepatitis B virus (HBV) vaccination is essential in chronic liver disease (CLD), because it can help prevent acute-on-chronic disease, which has potentially fatal complications. Unfortunately, this group has a significant proportion of HBV vaccination non-responders. A variety of intra-muscular (IM) vaccination methods have been used in an attempt to remedy this poor-response, but with limited success. Herein is reported the safety and efficacy of high-dose intra-dermal (ID) HBV vaccination in CLD individuals who had failed previous IM standard and boost-dosing regimens. Forty-eight CLD individuals, known HBcAb negative, who had failed both a three-dose schedule of 40 μg IM vaccination, and boost dosing of either 40 or 80 μg IM, were identified, of which 42 completed the vaccination course. Each received a 40 μg ID total dose (20 μg per arm) during their clinic visits until a response was documented or a maximum of three doses had been administered. HBsAb titer ≥ 10 mIU/ml was regarded as an immunologic response; the intention was to achieve an optimum response of ≥ 100 mIU/ml. Twenty-nine of forty-two (69%) individuals had an immunologic response, with 15 (51%) of the responders having the optimum response. No changes in serologic data occurred. No serious dermatologic reactions were observed. No differences between those who responded and those who did not were observed with regard to the presence of cirrhosis, diabetes mellitus, or chronic kidney disease. High-dose ID HBV vaccination of previous CLD non-responders to the standard IM regimen with boost dosing is both safe and efficacious, and should be considered for all such groups.