Discussions About Hepatitis B Vaccination

Hepatitis B virus infection is an important health problem worldwide with nearly 2 billion people infected and about 350 million chronic carriers(1,2). Though there has been a marked reduction in the incidence of hepatitis B virus infection in hemodialysis units compared to earlier data , probably due to screening of blood donors, decrease in blood transfusion requirements with more use of erythropoietin and the development of guidelines for infection control and vaccination, still there is a higher prevalence of HBV infection among hemodialysis patients than in the general population .

It is because of increased exposure to blood products and shared hemodialysis equipment with impaired immune response in chronic kidney disease patients (3). The prevalence of hepatitis B virus among Indian dialysis population varies from 20 to 45% but in Western countries it is < 1 %.(4,11)

The Centers for Disease Control and Prevention recommends that all dialysis patients should be vaccinated against HBV with double the standard dose (40µg) and intensified schedule (0, 1, 2, 6). But the response in CKD patients on haemodialysis even with intensified schedule as recommended by CDC guideline is low (50%-60%).

(5,19) There are only very few Indian studies available regarding immune response following HBV vaccination and various factors determining it in dialysis patients.We studied the immune response in healthy individuals, in dialysis patients and analyzed various factors that had an influence on immune response such as sex,age,duration of dialysis, diabetes, smoking, anaemia, body mass index, albumin level and adequacy of dialysis.

In this study we compared the sero conversion rate following 4 doses of 40µg of recombinant Hepatitis B virus vaccine (HBV vaccine) administered to chronic kidney disease Stage-V patients undergoing haemodialysis (N=34) to healthy adult volunteers with 3 doses of 20µg recombinant HBV vaccine (N=30).

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AntiHBs titer ≥ 10mIU/ml (immne responder) was present in 82% of patients undergoing haemodialysis and the titre of >10Miu/ml was present in all the healthy control volunteers (100%).

Shepard CW et al and Lai LL et al in their studies showed that seroprotection rate in normal healthy individuals following standard-dose vaccination strategy of 3 doses of 0, 1, 2 months with 20µg HBsAg with 0.5mg aluminium salt as adjuvant was around 95% (12,58).Almost similar to this one, the seroprotection rate following 3 doses of 20 µg of HBV vaccine to healthy adults in our study was 100%.

But the seroprotection rate following 4 doses of 40 µg of HBV vaccine was reported to be 60% by Tokar J I et al and Prabhat Singh et al (12,15) in their studies. In our study the seroprotection rate was 82%.Some studies also observed the response rate of 80% in dialysis patients.(28). Also dialysis patients develop lower peak antibody titer which persists for shorter duration than normal healthy population (17,18). In our study the mean antiHBs titer in dialysis patients was 24.7mIU/ml compared to 31.8mIU/ml in healthy individuals.

Among 34 patients in this study group, 7 were females(20.6%) and 27 were males (79.4%).Thus men were the predominant group.86% of females and 82% of males were found to be immune responders and there was no statistically significant difference between them regarding immune response. In a study by Hans Kohler et al , 66% of female patients and 50% of male dialysis patients developed seroconversion following HBV vaccine.However he had found that the sex difference for seroconversion rate was not statistically significant.

In our study age varied from 18 to 64 years with mean age of 35.88±12.13.Majority of them were more than 40 years old (41.2%) followed by 20-30 years age group(32.4%).There was no significant difference regarding immune response between different age groups.But Fabrizi et al and Fisman DN et al (41,38) in their meta-analysis of the effect of age on immune response to HBV vaccination in chronic kidney disease patients on haemodialysis found a decrease in serological response with older age. Also Hans Kohler in his study shown that the mean age of patients who develop immune response was 39.8 years compared to patients with 52.8 years who did not develop immune response.

None of the native kidney disease was found to be significantly associated with immune response following HBV vaccine in this study group as in other studies. Duration of dialysis in our study population varied from 5 months to 23 months with mean duration of 11.8±7.07 and most of them had undergone 6- 8 months (70.5%) of dialysis.There was no significant association seen between duration of dialysis and immune response in our study population. According to Hans Kohler et al the mean length of the time on dialysis had no impact on immune response.

Most of the patients in this study group were non-diabetic (82.4%) and only 17.6% were diabetic. Among 6 diabetic patients, diabetic nephropathy was the underlying cause for chronic kidney disease in 5 of them.85.7% of patients among non diabetics were immune responders compared to 66.7% among diabetics.Thus the immune response rate was better in non diabetics (85.7%) compared to the diabetics (66.7%). Sarah F. Schillie et al and Alavian et al (32,33) in their systematic reviews reported the sero protection rate after HBV vaccination in patients with diabetes varied from 34% to 80%. Most of the studies also confirmed this. But Lacson et al reported null association between diabetes and immune response in dialysis patients.