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Effect of levamisole supplementation on tetanus vaccination response rates in haemodialysis patients: A randomized double-blind placebo-controlled trial

Authors

  • Mohammad Kazem Fallahzadeh,

    1. Shiraz Nephrology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
    2. WK John C. McDonald Regional Transplant Center and Division of Nephrology, Department of Medicine, LSUHSC-S, Shreveport, Louisiana, USA
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  • Sharareh Sajjadi,

    1. Shiraz Nephrology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
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  • Neeraj Singh,

    1. WK John C. McDonald Regional Transplant Center and Division of Nephrology, Department of Medicine, LSUHSC-S, Shreveport, Louisiana, USA
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  • Masomeh Khajeh,

    1. Shiraz Nephrology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
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  • Mohammad Mahdi Sagheb

    Corresponding author
    1. Shiraz Nephrology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
    • Correspondence:

      Dr Mohammad Mahdi Sagheb, Department of Medicine, Nemazee Hospital, Shiraz, Iran. Email: saghebf@gmail.com

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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.

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