A Prospective Study of Hepatitis B Vaccination – A Comparison of Responders versus Nonresponders

Abstract

Herein we present one of the largest single-center reports of the response of hemodialysis patients to a two-vaccine hepatitis B virus vaccination protocol in a European dialysis population. A hepatitis B recombinant DNA vaccine, HBvaxPRO ® , was given at a dose of 40 μg intramuscularly using a four-dose schedule at 0, 1, 2, and 12 months. Responses were (1) a titer >100 mIU/mL = patient immune, (2) a titer level 10-99 mIU/mL = give a booster dose and recheck level 2 months later, and (3) 0 ≤ 10 mIU/mL = repeat vaccination course using a different vaccine, Engerix-B ® . We compared responder groups in terms of titer levels for each vaccine and variables including age, gender, serum albumin, parathyroid hormone (PTH), calcium, phosphate, hemoglobin, years on dialysis, and type of dialysis access. Of the 176 patients who received the first vaccine course, 71 patients achieved immunity, that is, 40% uptake for the first vaccine. Of the 105 who failed, 72 received the second vaccine with 46 responders, that is, 64% uptake for the second vaccine. Overall, 143 of the 176 patients who entered the vaccination program completed the protocol with 117 achieving immunity, representing an 82% success rate. The only variable overall to show significance in achieving seroconversion was serum albumin (p = 0.03). Using a two-vaccine protocol, hepatitis B vaccination response was high in our population of end-stage renal disease patients.

Single nucleotide polymorphisms of vitamin D binding protein, vitamin D receptor and retinoid X receptor alpha genes and response to hepatitis B vaccination in renal replacement therapy patients

“…Among such factors like gender, age at RRT onset, RRT vintage, prevalence of chronic glomerulonephritis as a cause of renal failure and mean serum PTH level, the VDR rs1544410 polymorphism was not a significant predictor of being responder or non-responder to hepatitis B vaccination. Age [2,6,32], chronic glomerulonephritis as a cause of ESRD [32] and RRT vintage [32] were already known to be associated with responder/non-responder status to active immunization against HBV in RRT patients, whereas male gender [2][3][4]6,8] and serum PTH level [4] were reported as not influencing a seroconversion rate in HD patients. In our study, HD men were younger at RRT onset and had higher plasma 25 (OH)D levels than HD women; therefore, they showed strong expression of factors being positive predictors of effective immunization in this study and in earlier reports [6,8,32].…”

“…Worse response rates to hepatitis B vaccination among chronic kidney disease (CKD) patients, especially those on RRT, were correlated among others with malnutrition [7], low serum albumin levels [4,7] and recently with low serum 25-hydroxycholecalciferol [25 (OH)D] levels [8].…”

“…However, despite a four-dose vaccination regimen with doubled each vaccine dose (40 mg), 10.4-55.7% of hemodialysis (HD) patients do not elicit sufficient levels (>10 u/l) of antibodies to HBV surface antigen (anti-HBs) [1][2][3]. Booster doses usually improve that response; however, numerous patients still do not develop immunity after them [1,4]. Furthermore, HD patients who develop immunity to HBV tend to lose it earlier than healthy vaccine recipients [5,6].…”

“…Booster doses usually improve that response; however, numerous patients still do not develop immunity after them [1,4]. Furthermore, HD patients who develop immunity to HBV tend to lose it earlier than healthy vaccine recipients [5,6].Worse response rates to hepatitis B vaccination among chronic kidney disease (CKD) patients, especially those on RRT, were correlated among others with malnutrition [7], low serum albumin levels [4,7] and recently with low serum 25-hydroxycholecalciferol [25 (OH)D] levels [8].The active form of vitamin D (VD), 1,25-dihydroxycholecalciferol [1,25(OH) 2 D], plays a significant role in the immune response. 1,25(OH) 2 D decreases the expression of inflammatory cytokines and at the same time stimulates anti-microbial activity of neutrophils, monocytes, natural killer cells and the mucosal immunity.…”

Prophylactic vaccinations in chronic kidney disease: Current status

“…8 Infection-cause mortality was shown to be lower in responders than in non-responders to hepatitis B vaccination. 22 Despite decreased immunocompetence, multiple other reasons of hepatitis B vaccination failure were recognized in CKD patients (older age at the primary vaccination, male gender, type of renal disease leading to ESRD, co-morbid diseases, malnutrition, especially low serum albumin level, 23 but also obesity). In last years, further factors have been indicated as having impact on effects of hepatitis B vaccination, like protein catabolic rate.…”