A Randomized Controlled Trial of Seroconversion After 20 Mg versus 40 mg Intramuscular Hepatitis B Virus Vaccination in Patients with Chronic Kidney Disease Stage 3

Abstract

Background: There is as yet no guideline for hepatitis B virus (HBV) vaccination in chronic kidney disease (CKD). There is also insufficient evidence to support the theory that the immune response to a double dose (40 μg) of HBV vaccine is greater than that achieved by the standard dose (20 μg).

Objective: To compare seroconversion of the four-dose regimen (at 0, 1, 2, 6 months) of intramuscular recombinant DNA HBV vaccination using the standard 20 μg with that of 40 μg in patients with CKD stage 3.

Material and method: This study included 39 patients with CKD stage 3 who had neither history of HBV vaccination nor markers of HBV infection, namely hepatitis B surface antigen (HBs Ag), antibody to hepatitis B core antigen (anti-HBc), or antibody to hepatitis B surface antigen (anti-HBs). After randomization, 20 patients were given 20 μg and 19 patients received 40 μg of vaccine in a four-dose regimen of HBV immunization. Immune response was assessed by measuring anti-HBs at the 2nd, 6th, 7th and 12th months. Anti-HBs at levels equal to or more than 10 IU/L were considered to constitute seroconversion.

Results: Rates of seroconversion in the 20 μg versus the 40 μg groups at the 2nd, 6th, 7th, 12th month were 50.0%:52.6% (p = 0.869), 65.0%:100.0% (p = 0.004), 95.0%:100.0% (p = 0.323) and 80.0%:100.0% (p = 0.040) respectively. Six months after completing the vaccination, some patients (20.0%) in the 20 μg group had lost their immune response while all in the 40 μg group still maintained their seroconversion. During the study, there was no significant change in eGFR in the two groups (p>0.05), and minor adverse effects including local pain, malaise, fatigue, and dizziness were not significantly different between the two groups.

Conclusion: Seroconversion rates of the two groups were not significantly different after completion of HBV vaccination, but only patients in the group receiving the double dose were able to maintain seroconversion 6 months later. The proper hepatitis B vaccination for patients with CKD stage 3 with negative makers of HBV should be immunization with a four-dose regimen using 40 μg of vaccine.