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• W4385664679 abstract "We would like to draw attention to the issue that anti-tetanus immunoglobulin (TIG), that is, human immunoglobulin (IG) with known antibody content against the neurotoxin, is essential medicine (WHO) for post-exposure prophylaxis (PEP) and therapy of tetanus [1-3]; yet, TIG is not available in all countries [1] or has been difficult to obtain in recent years [4]. In the absence of TIG, PEP with human IG for intra-muscular immunoglobulin (IMIG) or subcutaneous immunoglobulin (SCIG) use is an alternative [4]. For tetanus treatment, intravenous immunoglobulin (IVIG) at a dose of 200–400 mg/kg is recommended in the United States [1], whereas in the United Kingdom, a fixed dosage with selected IVIG preparations was defined [4]. As IG is not routinely tested for tetanus antibody concentrations, little information is available on lot-to-lot variability and dosage required to administer the recommended 250–500 IU of tetanus antibody for PEP or 3000–10,000 IU for therapy [1-4]. In this context, we received requests on tetanus antibody levels in 10% immunoglobulin for infusion (IGI) from practitioners recently, which reflects the need for further information. We, therefore, investigated tetanus antibody concentrations of current 10% IGI preparations manufactured in 2021 from plasma collected in the United States and European Union, by apheresis (source plasma) as well as from blood donations (recovered plasma), which can be administered as IVIG (Gammagard Liquid/KIOVIG) as well as SCIG (HyQvia), using the Tetanus IgG enzyme-linked immunosorbent assay (ELISA) (Virotech Diagnostics GmbH, Rüsselsheim, Germany) and methodology validated according to ICH principles, reporting results against the second WHO International Standard for Anti-Tetanus Immunoglobulin Human (NIBSC code: 13/240). We determined a mean ± standard deviation (SD) anti-tetanus potency of 29.2 ± 2.0 IU/mL for recent IGI, 10% lots (Table 1), where lots fractionated from US plasma had significantly (p < 0.0001) higher tetanus toxin antibody content (30.8 ± 1.2 IU/mL) than lots fractionated from EU plasma (27.5 ± 1.2 IU/mL). The lowest antibody concentration determined in any lot was 26.0 IU/mL (Table 1). There was no relevant difference in tetanus toxin antibody content for IGI lots fractionated from source or recovered plasma. These data were brought into context with tetanus toxin antibody concentrations reported for other IGI preparations by the National Institute for Biological Standards and Control (NIBSC) [4], where a selection for more recent test date (i.e., tested in 2016–2019) was made and values were normalized to 10% protein content. When tetanus toxin antibody concentrations of 39 lots of 13 different commercial IGI products of six different manufacturers [4] were normalized for protein content, a mean potency of 30.5 ± 2.5 IU/mL was calculated (Table 1), very similar to the antibody concentration determined in the current IGI, 10% preparations. Our investigation showed that normal human IG preparations contain tetanus toxin antibodies at remarkably similar concentrations. This is true for lots of the same manufacturer, as well as for different commercial preparations of several manufacturers (Table 1) [4]. A difference in tetanus potency was seen for the 10% IGI preparations analysed here depending on the origin of plasma that was used for fractionation, that is, higher potency was seen in US plasma-derived IGI than in EU plasma-derived IGI. The geographic difference in tetanus potency was already reported previously and had been related to differences in tetanus vaccination policy and vaccine potency [5]. As the slightly lower tetanus toxin antibody content in EU plasma-derived IGI still provides for dosages well within PEP and therapy recommendations (see below), this potential lot-to-lot difference does not appear clinically relevant. A serum tetanus toxin antibody concentration of ≥0.1 IU/mL is indicative of immune protection. The 10% IGI preparations tested here are suitable for subcutaneous as well as intravenous application, making them amendable for tetanus PEP as well as tetanus therapy. With respect to PEP of tetanus, 10–20 mL of 10% IGI should suffice to administer the recommended 250–500 IU of tetanus antibody, assuming the lowest tetanus potency that was determined, that is, 26.0 IU/mL (Table 1). This corresponds well with the recommendation to manage tetanus-prone wounds with 4.5–9 mL of 20% SCIG [4], a product that is manufactured by the same pathway as the 10% IGI lots tested here, with a final adjustment of protein content. For tetanus therapy with 10% IVIG, a person with 80 kg of body weight would receive 4160 IU of tetanus antibodies, assuming treatment with the lowest recommended dosage of 200 mg/kg [1] and the lowest tetanus potency that was determined for a lot here (Table 1), that is, a dosage well within the recommended 3000–10,000 IU for therapy [1-4]. In conclusion, we provide comprehensive evidence that current 10% IGI preparations consistently contain tetanus antibodies at levels that allow for tetanus PEP as well as tetanus therapy, with negligible lot-to-lot variability. Although TIG does have the benefit of smaller volumes being required for treatment, the information of consistent anti-tetanus potency in 10% IGI aids to alleviate concern about the uncertain availability of specific TIGs and opens further options for tetanus PEP and treatment. The contributions of the Global Pathogen Safety/Serology team, most notably Patricia Stangl (ELISA testing) are gratefully acknowledged. This study was funded by Takeda Manufacturing Austria AG. M.R.F and T.R.K conceived the study; A.S. supervised the study; M.R.F and C.L. analysed the data and wrote the manuscript. All the authors revised the manuscript and contributed significantly to the final version of the manuscript. The authors are employees of Takeda Manufacturing Austria AG, Vienna, Austria. M.R.F and T.R.K have Takeda stock interests. The data that support the findings of this study are available from the corresponding author upon reasonable request." @default.
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• W4385664679 date "2023-08-08" @default.
• W4385664679 modified "2023-10-17" @default.
• W4385664679 title "Tetanus antibodies in normal human immunoglobulin preparations" @default.
• W4385664679 cites W2064275922 @default.
• W4385664679 doi "https://doi.org/10.1111/vox.13506" @default.
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