At 1 month, 13 out of 16 (81%) patients in the levamisole group as compared with six out of 18 (33%) patients in the placebo group developed protective anti-tetanus IgG levels

(relative risk = 2.44, 95% confidence interval (CI) = 1.21, 4.88). From 1 to 6 months post-vaccination, one more patient in the levamisole group and two more patients in the placebo group were excluded because of renal transplantation. Cilomilast ic50 At 6 months, 11 out of 15 (73%) patients in the levamisole group as compared with four out of 16 (25%) patients in the placebo group still had protective anti-tetanus IgG levels (relative risk = 2.93, 95% CI = 1.19, 7.23). Supplementation of Td vaccination with levamisole may enhance seroconversion against tetanus in haemodialysis patients. Compared with healthy population, haemodialysis patients are more susceptible to infections like tetanus[1-3] and experience lower seroconversion rate following vaccination because of their impaired immune system.[3-5] One of the strategies to increase the rate of seroconversion in these patients is to boost the immune system with immunostimulatory agents.[6] Levamisole is an immunomodulatory drug that stimulates depressed T cell activity

and enhances the production of antibodies by B cells.[6, 7] This anti-helminthic drug has been reported to increase the seroconversion rate following hepatitis B virus (HBV) vaccination.[6, 7] However, the possible enhancing effects of this drug on the response rates Selleck Stem Cell Compound Library of other vaccines like tetanus have not been studied. Therefore, the aim of the current study was to evaluate the effect of levamisole supplementation on tetanus vaccine response rate in haemodialysis patients. This

randomized double-blind placebo-controlled trial was approved by the Institutional Review Board of Shiraz University of Medical Sciences and was done in accordance with BCKDHA the Declaration of Helsinki and Good Clinical Practice guidelines. Eligible participants were 20- to 80-year-old patients on regular haemodialysis in Faghihi Hospital Dialysis Center for more than 3 months who had unprotective anti-tetanus immunoglobulin G (IgG) levels as defined by the World Health Organization (WHO) (<0.1 international unit (IU)/mL). Exclusion criteria were: tetanus diphtheria (Td) vaccination in past year, leukopenia (white blood cell count < 1500 cells/mcL), immunosuppressive drug exposure in past 2 months, and recent hospitalization or history of transfusion of blood products in the past 3 months. In accordance with previous studies evaluating the effect of levamisole on HBV vaccination response in haemodialysis patients,[8, 9] a sample size of 12 patients per group was calculated considering two-sided significance level of 5%, power of 80% and response rates of 75% and 25% in levamisole and placebo groups, respectively. Considering a drop-out rate of 40%, a sample size of 20 patients per group was finalized.