Efficacy and Safety of Reinforced Versus Standard Vaccine Schedule Towards Hepatitis B In Chronic Kidney Disease: A Systematic Review and Meta-Analysis

Abstract

Context: The immunogenicity of the hepatitis B virus vaccine is reduced in patients with renal failure compared with the nonuraemic population. A variety of approaches have been suggested to improve the immune response in uraemic population including an increase in dose of the hepatitis B vaccine. Objective: To compare the efficacy and safety of hepatitis B vaccine schedules based on greater versus standard doses of HB vaccine in patients with chronic kidney disease stages 3 -5. Evidence Acquisition: We carried out a systematic review of the medical literature with a meta-analysis of randomized trials comparing seroprotection rates after greater vs. standard doses of the HB vaccine. The odds ratio to obtain seroprotection among patients who received greater (study group) vs. standard (control group) doses was the end-point of interest. We used a random-effects approach, as described by DerSimonian and Laird, with heterogeneity and subgroup analyses. Results: We retrieved 11 clinical trials (n = 870 unique patients); 2 (n = 141 patients) and 8 studies (n = 689) included CKD patients on pre-dialysis and dialysis stage, respectively. Three trials (n = 368 patients) employed plasma-derived vaccine; 8 (n = 502) adopted recombinant vaccine. Aggregation of study results (n = 10 studies) showed that the seroprotection rate (short-term follow-up) towards HB virus was higher among patients receiving greater than standard doses of vaccine [pooled OR, 2.10, 95% confidence intervals, 1.15 -3.82]. The P-value was 0.0001 for our test to study heterogeneity. The seroprotection rate towards HBV was much greater in the subset of trials (n = 2) based on plasma-derived vaccine (OR, 3.78; 95% CI, 2.35; 6.07), and no heterogeneity was found (NS). In the subset of RCTs (n = 8 studies), the seroprotection rate was higher among patients receiving greater doses of vaccine towards HBV, OR, 2.01 (95% CI, 0.92; 4.39), with significant heterogeneity (P = 0.002). Tolerance was satisfactory and no dropouts due to side effects were reported. Conclusions: Vaccine schedules based on greater than standard doses of HB vaccine offer higher immunogenicity in patients with chronic kidney disease. These results support the current recommendations to give higher doses of HBV vaccine to susceptible dialysis population in order to increase the sero-protection rate. Further research is needed to assess whether these findings apply to HB vaccines provided with novel adjuvants.

Comparison of antibody response to two different mRNA Covid-19 vaccines in patients on hemodialysis

“…In our study, patients treated with BNT162b2 had a median of 297 U/mL (interquartile range 851 U/mL), which was comparable to what was detected by Simon et al [ 13 ] (171 U/mL, interquartile range 478 U/mL), and by Yanay et al [ 16 ], using a different assay. In the past, because of the immunocompromised status of uremic patients [ 17 ], different approaches were suggested in an attempt to improve the immune response, including increasing the dose of vaccine to protect from Hepatitis B [ 7 ]. Therefore, the first experiences with the vaccine against SARS-CoV-2 infection were very important to establish vaccination plans in this high risk population.…”

“…Nevertheless, the possible hyporesponsiveness to vaccines due to reduced innate and adaptive immune systems should not prevent patients on dialysis from receiving vaccination [ 6 ]. Higher vaccine dosage or scheduling changes were required in patients with Hepatitis B [ 7 ].…”

Hepatitis B vaccination in patients with stage 4/5 chronic kidney disease – a scoping review

“…Due to concerns over the transmission of HIV through plasma products, the first generation HBV vaccines were replaced by the second generation vaccines that used synthetic recombinant DNA technique (Jilg et al, 1986;Koumadakis et al, 2018). A third generation recombinant HBV vaccine containing pre-S1 and pre-S2 antigen expressed in mammalian cells has been developed and licensed in some countries only (Schouval, Roggendorf & Roggendorf, 2015;Fabrizi, Donato & Messa, 2017;El Hanan et al, 2018). Current vaccination is safe and effective.…”

INASL Guidelines on Management of Hepatitis B Virus Infection in Patients receiving Chemotherapy, Biologicals, Immunosupressants, or Corticosteroids

“…Therefore, it may be best to screen CKD patients early and initiate vaccination as appropriate. [194][195][196][197] Patients on dialysis are recommended to receive four doses of a recombinant hepatitis B, at a higher than standard dose of 40 mcg, at 0, 1, 2, and 6 months. 198 The persistence of immunity hepatitis B vaccine in hemodialysis patients was tested over a 3-year period.…”