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Abstract(Please copy/paste the abstract send to the congress) : |
Zahra Khazaeipour,1 Farokhlagha Ahmadi.2
1.Zahra Khazaeipour, Brain and Spinal Cord Injury Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.
2. Nephrology Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Tel: +98- 21-66581561, Fax: +98-21-6693885
E-mail: z_kh14@yahoo.com; khazaeipour@ tums.ac.ir
Background
Patients with chronic renal disease should be vaccinated as soon as dialysis is forestalled, and this could improve the seroconversion of hepatitis B vaccination.
Objectives
In this study, we aimed to compare seroconversion and immune response rates using 4 doses of 40 μg and 3 doses of 20 μg Euvax B recombinant Hepatitis B surface Antigen (HBs Ag) vaccine administered to predialysis patients with chronic kidney disease (CKD).
Patients and Methods
In an open, randomized clinical trial, we compared seroconversion rates in 51 predialysis patients with mild and moderate chronic renal failure who received either 4 doses of 40 μg or 3 doses of 20 μg of Euvax B recombinant hepatitis B vaccine administered at 0, 1, 2, 6 and 0, 1, 6 months, respectively.
Patients were followed to assess routine laboratory markers of chronic kidney disease (Glomerular filtration rate [GFR], Cr, Na, K, Ca, P, and so on) and a clinical examination was performed every 3 months. GFR was calculated using the Cockcroft-Gault formula. Blood samples were taken before 6 months as well as 8–10 weeks after the 6-month dose, and were assayed for the presence of antibodies against HBs Ag (anti-HBs) using a commercial enzyme immunoassay (EIA) produced by Abbott Laboratories (AUSAB, Abbott Laboratories, Abbott Park, IL, USA).
Hepatitis B Markers
Hepatitis B surface antibody was determined using an anti-hepatitis B surface antibody quantitative chemiluminescence assay (EIA) produced by Abbott Laboratories (AUSAB, Abbott Laboratories, Abbott Park, IL, USA) at Noor laboratory, Tehran, Iran. Anti-HBs titers are expressed in mIU/ml compared with standard immunoglobulin preparations (Ortho- Clinical Diagnostics). Anti-HBs titers < 10 mIU/ml were defined as non-seroconversion (non-responder). Anti-HBs titers ≥ 10 mIU/ml were defined as seroconversion.
Results
The mean HBs Ab level after 4 doses of the 40 μg vaccine (182.2 ± 286.7) was higher than that after 3 doses of the 20 μg vaccine (107.6 ± 192.1), but the difference was not significant (P = 0.3). After 4 doses of the 40 μg vaccine, the cumulative seroconversion rate (HBs Ab ≥ 10 mIU/ml) was not significantly different (21/26, 80.8%) than that after 3 doses of 20 μg (23/25, 92%) P = 0.41). Multivariable analysis showed that none of the variables contributed to seroconversion.
Conclusions
We found that the 4-dose 40 μg HBV vaccine did not lead to significantly greater seroconversion than 3 doses of 20 μg. Thus, it is perhaps not necessary to introduce a 4-dose 40 μg HBV vaccination schedule to replace the 3-dose 20 μg schedule for predialysis vaccination of patients with stage 3 and 4 CKD. However, further studies with a larger sample size are required. |