Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2018 Oct;9(5):278-282.
doi: 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

Chan Woong Choi  1 , Jae Hoon Moon  2 , Jae Ok Kim  1 , Si Hyung Yoo  1 , Hyeon Guk Kim  3 , Jung-Hwan Kim  4 , Tae Jun Park  1 , Sung Soon Kim  1
Affiliations

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

Chan Woong Choi et al. Osong Public Health Res Perspect. 2018 Oct.

Erratum in

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.

Keywords: diphtheria toxoid; potency; tetanus toxoid; vaccine.

PubMed Disclaimer

Conflict of interest statement

Conflicts of Interest The authors have declared no conflicts of interest.

Figures

Figure 1
Figure 1
Comparison of the results of lethal challenge and in vivo toxin neutralization assays for diphtheria toxoid. (A) When the potency of diphtheria toxoid was calculated through lethal challenge assay, all 15 vaccine lots had appropriate potencies satisfying the limits for adult vaccines of 2 IU/0.5 mL. (B) The results of in vivo toxin neutralization assay showed potencies exceeding 1 unit/mL for all vaccine lots.
Figure 2
Figure 2
Comparison of the results of lethal challenge and in vivo toxin neutralization assays for tetanus toxoid. (A) When the potency of tetanus toxoid was calculated through lethal challenge assay, all 15 vaccine lots had appropriate potencies satisfying the limits for adult vaccines of 20 IU/0.5 mL. (B) The results of in vivo toxin neutralization assay showed potencies exceeding 8 units/mL for all vaccine lots.
See this image and copyright information in PMC

References

    1. Lee HJ, Choi JH. Tetanus-diphtheria-acellular pertussis vaccination for adults: an update. Clin Exp Vaccine Res. 2017;6(1):22–30. doi: 10.7774/cevr.2017.6.1.22. - DOI - PMC - PubMed
    1. Trucchi C, Zoppi G. Decennial diphtheria-tetanus adult boosters: are they really necessary? J Prev Med Hyg. 2015;56(1):E44–8. - PMC - PubMed
    1. Gautret P, Wilder-Smith A. Vaccination against tetanus, diphtheria, pertussis and poliomyelitis in adult travelers. Travel Med Infect Dis. 2010;8(3):155–60. doi: 10.1016/j.tmaid.2010.02.007. - DOI - PubMed
    1. MFDS Notification No. 2016-111. Ministry of Food and Drug Safety; 2016. Minimum requirements for biologics (Korea), Amended on October 4, 2016.
    1. Manual for Quality Control of Diphtheria, Tetanus and Pertussis Vaccines. World Health Organization; 2013.