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.

Effects of adjuvants (granulocyte-macrophage colony-stimulating factor, levamisole, adjuvant system 04, adjuvant system 02B) on enhancing immune response to hepatitis B vaccine: a systematic review and meta-analysis

“…In the nine articles in this meta-analysis examining the effect of levamisole as an adjuvant on the HBV vaccine, individuals receiving a combination of the HBV vaccine and GM-CSF had a higher response rate (84.06%) compared with those who had the HBV vaccine alone (65.4%). These findings were in agreement with the results of many other studies in this area [5,19,20]. Some researchers have also recommended the application of levamisole to increase response rates to HBV due to its availability and low cost.…”

Dendritic Cell Dysfunction in Patients with End-stage Renal Disease

“…Based on these molecular mechanisms, several clinical studies have shown that when administered together with certain vaccines such as HBV and tetanus-diphtheria, levamisole can improve seroprotection in patients with ESRD on HD ( 78 79 80 81 ), whereas a few other studies did not show a beneficial effect ( 82 83 ). Moreover, a meta-analysis of four studies (328 patients) showed that the oral administration of levamisole at a dose of 80~120 mg for 4~6 months significantly increased seroconversion after HBV vaccination ( 75 ).…”

Effectiveness of oral levamisole as an adjuvant to hepatitis B vaccination in healthcare workers non-responsive to previous vaccination: A randomized controlled trial

“…Levamisole stimulates T lymphocytes and macrophages and improves cellular immunity [ 18 ]. Moreover, it has positive effects on the response rate of hemodialysis patients to tetanus vaccination [ 19 ].…”