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<p>In the current study, zinc hydroxide gel was prepared as an adjuvant system for adsorption of tetanus toxoid antigen. The vaccine’s efficacy was established by estimating different immunological markers (IgG, IL-1α, IL-1β, IL-6) against tetanus antigen in mice (<i>n</i> = 48, Swiss albino Balb/C strain) at suitable intervals to develop protective antibody titers. The safety of the test formulation was confirmed by specific toxicity studies in guinea pigs (<i>n</i> = 7, Dunkin Hartley strain). The efficacy of the tetanus toxoid vaccine such prepared was increased by incorporating zinc that activated both humoral and cell-mediated immune responses. The test formulation demonstrated improved potency (113.8&#xa0;IU/SHD) compared with the control formulation (106.4&#xa0;IU/SHD). Toxicity studies were conducted on mice and guinea pigs to ensure safety. The test formulation (containing zinc hydroxide as adjuvant) showed a majority of small-sized particles (2.0–5.0&#xa0;µm) compared to the control, with few larger particles (&gt; 100&#xa0;µm). Immunological markers were elevated in the test formulation compared to the control, indicating a better immune response. The low zinc concentration in the test formulation could reduce potential toxicity risks.</p> Graphical Abstract <p></p>

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Evaluation of Suitability, Efficacy, and Safety of Zinc Hydroxide Adjuvant System Adsorbed on Tetanus Toxoid Vaccine

  • 期刊论文

  • 发表日期：

    2025年11月6日

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  • Hassan Ahmed Khan,
  • Rizwanul Haq,
  • Abdul Aleem Awan,
  • Khalid Mehmood,
  • Shakira Ghazanfar,
  • Biplab Debnath,
  • Sumel Ashique,
  • Mohini Mondal,
  • Sathvik Belagodu Sridhar,
  • Mohammad Yousuf Ansari,
  • Md Sadique Hussain

摘要

In the current study, zinc hydroxide gel was prepared as an adjuvant system for adsorption of tetanus toxoid antigen. The vaccine’s efficacy was established by estimating different immunological markers (IgG, IL-1α, IL-1β, IL-6) against tetanus antigen in mice (n = 48, Swiss albino Balb/C strain) at suitable intervals to develop protective antibody titers. The safety of the test formulation was confirmed by specific toxicity studies in guinea pigs (n = 7, Dunkin Hartley strain). The efficacy of the tetanus toxoid vaccine such prepared was increased by incorporating zinc that activated both humoral and cell-mediated immune responses. The test formulation demonstrated improved potency (113.8 IU/SHD) compared with the control formulation (106.4 IU/SHD). Toxicity studies were conducted on mice and guinea pigs to ensure safety. The test formulation (containing zinc hydroxide as adjuvant) showed a majority of small-sized particles (2.0–5.0 µm) compared to the control, with few larger particles (> 100 µm). Immunological markers were elevated in the test formulation compared to the control, indicating a better immune response. The low zinc concentration in the test formulation could reduce potential toxicity risks.

Graphical Abstract