Osong Public Health Res Perspect.  2018 Oct;9(5):278-282. 10.24171/j.phrp.2018.9.5.10.

Evaluation of Potency on Diphtheria and Tetanus Toxoid for Adult Vaccines by In Vivo Toxin Neutralization Assay Using National Reference Standards

Affiliations
  • 1Biologics Research Division, National Institute of Food and Drug Safety Evaluation, Cheongju, Korea. sungskim63@korea.kr
  • 2Green Cross Research Center, Yongin, Korea.
  • 3Biologics Division, National Institute of Food and Drug Safety Evaluation, Cheongju, Korea.
  • 4Vaccines Division, National Institute of Food and Drug Safety Evaluation, Cheongju, Korea.

Abstract


OBJECTIVES
Vaccinations against diphtheria and tetanus are essential in providing immunity against these bacterial infections. The potency of diphtheria and tetanus toxoid vaccines can be measured using the in vivo toxin neutralization assay. The limit of potency of this assay was determined only for children. Therefore, we assessed the potency of adult vaccines using this assay to identify the feasibility of limit for adult vaccines.
METHODS
Fifteen lots of tetanus-reduced diphtheria and tetanus-diphtheria-acellular pertussis vaccines were used. In vivo toxin neutralization and lethal challenge assays were conducted on each vaccine to calculate the potencies of the toxoids. National reference standards for toxins and antitoxins were used for in vivo toxin neutralization assay.
RESULTS
All 15 lots satisfied the limits of potency for lethal challenge assay. The potency of diphtheria and tetanus toxoids exceeded 1 and 8 units/mL, respectively, for in vivo toxin neutralization assay.
CONCLUSION
Although additional studies are required for new assays and limits, the current level of potency for adult vaccines as determined by in vivo toxin neutralization assay, was demonstrated in this study. Such efforts to improve assays are expected to promote the development of diphtheria and tetanus vaccines for adults and to contribute to vaccine self-sufficiency.

Keyword

diphtheria toxoid; potency; tetanus toxoid; vaccine
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