Immunogenicity of a Recombinant Hepatitis B Vaccine in Hemodialysis Patients: A Two-Year Follow-Up

Abstract

The immunogenicity of a recombinant hepatitis B vaccine was evaluated in 35 hemodialysis patients who received a standard dose (20 μg) of the vaccine at 0,1, 2 and 6 months. After the full vaccination course (month 7), 60% (21/35) of the patients had seroconverted (anti-HBs titer ≥10 mlU/ml). The duration of protection lasted up to 18 months after the start of vaccination in 85.7% (18/21) of the responders. At that time, an additional dose was given to all the patients: 1-2 months later, the overall immunization rate had increased to 65.7% (23/35); lastly, in month 24 (i.e., 6 months after the booster dose), 62.5% (15/24) of the patients available for evaluation were still maintaining protective levels of anti-HBs antibodies. Comparable results had previously been obtained in 21 well-matched patients on our dialysis program who were vaccinated with a plasma-derived vaccine according to the recommended schedule.

Immunogenicity and Efficacy of Hepatitis B Vaccination in Indian Chronic Renal Failure Patients on Hemodialysis and After Renal Transplantation

“…Studies from other centers have reported a seroconversion rate of 23-33% after 3 doses of vaccine at 0. 1 and 2 months which after the fourth booster dose was 40% [5] and 62% [1], The seroconversion rate after 3 doses of vaccination in our patient population of 58% was higher than in these reports. Neither the age nor the duration of HD seem to correlate with the seroconver sion rate.…”

T cell responses to hepatitis B surface antigen are detectable in non-vaccinated individuals

“…DRB1*0301, DRB1*0701, and DQB1*0201 [5,8,9] were shown to have a higher prevalence in non-responders, whereas other antigens (DRB1*0101, *1301, *1501, and DPB1*0401) seem to mediate strong immune responses [9][10][11][12] . Higher age, obesity, male gender, smoking, and chronic dialysis are risk factors for a non-/ low-responsiveness [8,9,[13][14][15] .…”

Recombinant Hepatitis B Vaccine Use in Chronic Hemodialysis Patients

“…There are few and little trials regarding the use of recombinant vaccine in HD subjects [5] in order to prevent HBV infection in this clinical set ting: they showed that the efficacy rate of a DNA-derived vaccine in the HD population is similar to the plasmaderived vaccines and lower than in healthy subjects [6]. The response rate to hepatitis B vaccine in HD patients is poor compared to healthy subjects for different reasons: the immunisation rate is lower, after completion of the vaccination schedule anti-HBs titers are lower and fall more rapidly [7], It has been calculated that anti-HBs lev els in the great majority of healthy vaccinées remain at higher than the minimal protective levels for about 5 years [8]: on the contrary, in HD patients about one third who respond to the vaccine program will become serone gative within 12 months of the first vaccine dose [7], Dif ferent schedules of DNA-derived vaccine have been pro posed in an attempt to increase the response rate: by intra muscular administration of multiple doses [9,10] or dou ble doses [11], by intramuscular administration inte grated with immunostimulators [12] or with intradermal injection [13], or by intradermal administration [14], Other authors proposed to modify the vaccine antigenic structure [15]: this observation has not been yet verified in HD subjects [16] and it has been partially confirmed in healthy subjects [17], However, many of these studies involved a very small number of HD patients, and the causes which have been shown to affect the HBV vaccine immunogenicity in HD subjects need more confirmation. Moreover, the persistence of anti-HBs in responder vacci nées and the factors which may influence the loss of antiHBs over time have not been extensively studied.…”