title: Effect of levamisole supplementation on tetanus vaccination response rates in haemodialysis patients: a randomized double-blind placebo-controlled trial.
abstract: Levamisole as an immunomodulator drug has been demonstrated to improve the immune response to hepatitis B virus vaccination in haemodialysis patients. The aim of this randomized double-blind placebo-controlled trial was to evaluate the effect of levamisole supplementation on tetanus-diphtheria (Td) vaccine response rates in haemodialysis patients. Forty haemodialysis patients who had not received tetanus vaccination in a year before investigation and had unprotective anti-tetanus immunoglobulin G (IgG) levels (<0.1 international unit/mL) were enrolled and randomized into two equal groups to receive one dose of intramuscular Td vaccine supplemented with either levamisole (100 mg) or placebo daily, for 6 days before and 6 days after vaccination. The anti-tetanus IgG levels were measured 1 and 6 months after vaccination. One month post-vaccination, four patients were excluded from the levamisole group and two from the placebo group because of either death or renal transplantation. 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. 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.
authors.affiliation: Shiraz Nephrology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran; WK John C. McDonald Regional Transplant Center and Division of Nephrology, Department of Medicine, LSUHSC-S, Shreveport, Louisiana, USA.
authors.forename: Mohammad Kazem
authors.initials: MK
authors.lastname: Fallahzadeh
authors.forename: Sharareh
authors.initials: S
authors.lastname: Sajjadi
authors.forename: Neeraj
authors.initials: N
authors.lastname: Singh
authors.forename: Masomeh
authors.initials: M
authors.lastname: Khajeh
authors.forename: Mohammad Mahdi
authors.initials: MM
authors.lastname: Sagheb
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage*; D000368:Aged; D000907:Antibodies, Bacterial / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D007978:Levamisole / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D006435:Renal Dialysis; D013745:Tetanus Toxoid / Q000276:immunology*; D014611:Vaccination
chemical_list: D000276:Adjuvants, Immunologic; D000907:Antibodies, Bacterial; D007074:Immunoglobulin G; D013745:Tetanus Toxoid; D007978:Levamisole
keywords: dialysis; kidney disease; levamisole; tetanus; vaccination