Compatibility and optimization of antigen content to develop combined acellular diphtheria-tetanus-pertussis (DTaP) vaccine at Institute of Vaccines and Medical Biologicals
Vol. 134 No. 1C (2025), Original Article
Vol. 134 No. 1C (2025)

Compatibility and optimization of antigen content to develop combined acellular diphtheria-tetanus-pertussis (DTaP) vaccine at Institute of Vaccines and Medical Biologicals

Original Article
https://doi.org/10.26459/hueunijns.v134i1C.7755
Published 2025-06-17
Nguyen Thi Thu Hoa*
Institute of Vaccines and Medical Biologicals, 9 Pasteur, Nha Trang City, Khanh Hoa Province, Viet Nam
Xuan Khanh Ha Nguyen
Institute of Vaccines and Medical Biologicals, 9 Pasteur, Nha Trang City, Khanh Hoa Province, Viet Nam
Van Duoc Nguyen
Institute of Vaccines and Medical Biologicals, 9 Pasteur, Nha Trang City, Khanh Hoa Province, Viet Nam
Ngoc Nhon Tran
Institute of Vaccines and Medical Biologicals, 9 Pasteur, Nha Trang City, Khanh Hoa Province, Viet Nam
Thi Lan Anh Pham
Institute of Vaccines and Medical Biologicals, 9 Pasteur, Nha Trang City, Khanh Hoa Province, Viet Nam
Thi Bich Trang Luong
Institute of Vaccines and Medical Biologicals, 9 Pasteur, Nha Trang City, Khanh Hoa Province, Viet Nam
Thi Lan Phuong Nguyen
Institute of Vaccines and Medical Biologicals, 9 Pasteur, Nha Trang City, Khanh Hoa Province, Viet Nam
Huu Thai Duong
Institute of Vaccines and Medical Biologicals, 9 Pasteur, Nha Trang City, Khanh Hoa Province, Viet Nam
PDF (Vietnamese)

Keywords

compatibility
optimized DTaP formulation
aluminum hydroxide adjuvant
IVAC tính tương thích
tối ưu công thức DTaP
tá chất nhôm hydroxide
IVAC

How to Cite

1.
Nguyễn TTH, Nguyễn XKH, Nguyễn V Được, Trần NN, Phạm TLA, Lương TBT, Nguyễn TLP, Dương HT. Compatibility and optimization of antigen content to develop combined acellular diphtheria-tetanus-pertussis (DTaP) vaccine at Institute of Vaccines and Medical Biologicals. hueuni-jns [Internet]. 2025Jun.17 [cited 2025Oct.31];134(1C):5-19. Available from: http://222.255.146.83/index.php/hujos-ns/article/view/7755
ACM ACS APA ABNT Chicago Harvard IEEE MLA Turabian Vancouver

Download Citation

Endnote/Zotero/Mendeley (RIS) BibTeX
Crossref
Scopus
Google Scholar
Europe PMC

Abstract

Compatibility between components and the amount of antigens in combination vaccines are important factors determining the safety, efficacy, and stability of that vaccine. To develop the diphtheria-tetanus-acellular pertussis (DTaP) vaccine at the Institute of Vaccines and Medical Biologicals (IVAC), we evaluated the compatibility among the components and optimized the amount of antigens in the vaccine formulation. The antigen components, including tetanus antigen (T), diphtheria antigen (D), and recombinant pertussis toxoid (rPT), together with filamentous haemagglutination factor (FHA), and aluminum hydroxide adjuvant, were evaluated for compatibility by using physicochemical and immunological methods. Design Expert version 12 software was used to optimize the amount of each antigen in the DTaP vaccine formulation. The results show that the components are compatible with each other. The optimal DTaP vaccine formula contains 40 Lf/mL D, 20 Lf/mL T, 10 µg/mL rPT, 20 µg/mL FHA, and 0.6 mg Al3+/mL respectively, corresponding to the diphtheria potency of 94,47 IU/mL, tetanus potency of 107,86 IU/mL, and pertussis potency of 9,65 IU/mL. The DTaP vaccine developed by IVAC meets the standard of the Vietnamese Pharmacopoeia V, 2018, of the Ministry of Health, and WHO.

https://doi.org/10.26459/hueunijns.v134i1C.7755
PDF (Vietnamese)

References

  1. Jatana SK, Nair M. Combination Vaccines, Med J Armed Forces India. 2007;63(2):167171.
  2. Edwards KM, Decker MD. Pertussis vaccine Vaccines. In: Plotkin SA, Orenstein WA, Offitt P, editors. 5th ed. USA: Saunders PA. 2008:471-528.
  3. Skibinski DA, Baudner BC, Singh M, O’Hagan DT. Combination Vaccines. J. Glob. Infect. Dis. 2011; 3(1):63-72.
  4. Obando-Pacheco P, Rivero-Calle I, Gómez-Rial J, Rodríguez-Tenreiro Sánchez C, Martinón-Torres F. New perspectives for hexavalent vaccines. Vaccine. 2018;36(36):5485-5494.
  5. Pham NT, Bui QT, Tran DM, Larsson M, Pham MP, Olson L. “Pertussis seasonal variation in Northern Vietnam: the evidence from a tertiary hospital. BMC Public Health. 2024;24(1):286.
  6. Kitamura N, Le TTT, Le LT, Nguyen LD, Dao AT, Hoang TT, et al. Diphtheria Outbreaks in Schools in Central Highland Districts, Vietnam, 2015–2018. Emerg Infect Dis. 2020;26(3):596-600.
  7. Pichichero ME. New combination vaccines. Pediatr Clin North Am. 2000;47(2):407-426.
  8. Insel RA. Potential alterations in immunogenicityin combining or simultaneously administering vaccine components. Ann N Y Acad Sci. 1995; 754:35-47.
  9. Halperin SA, King J, Law B, et al. Safety and immunogenicityof H influenza-tetanus toxoid conjugate vaccine given separately or in combination with a three component acellular pertussis vaccine combined with diphtheria and tetanus toxoid and inactivated poliovirus vaccine for the first four doses. Clin Infect Dis 28. 1999:995-1001.
  10. Weston WM, Klein NP. Kinrix: a new combination DTaP-IPV vaccine for children aged 4-6 years. Expert Rev Vaccines. 2008;7(9):1309-1320.
  11. Bộ Y tế. Dược Điển Việt Nam V, tập 1 và 2; 2018.
  12. Lampson G.P, Tytell A.A. A simple method for estimating isoelectric points. Analytical-biochemistry. 1965;11(2):374-377.
  13. Mahmood T, Yang PC. Western blot: technique, theory, and trouble shooting. N Am J Med Sci. 2012;4(9):429-434.
  14. Hong HA, Ke NT, Nhon TN, Thinh ND, van der Gun J W et al. Validation of the combined toxin-binding inhibition test for determination of neutralizing antibodies against tetanus and diphtheria toxins in a vaccine field study in Viet Nam. Bulletin of the World Health Organization. 1996;74(‎3):275-282.
  15. World Health Organization. Recommendations to assure the quality, safety and efficacy of acellular pertussis vaccines, WHO/TRS/No.979, 2014, annex 4.
  16. Gupta RK, Rost BE. Aluminum compounds as vaccine adjuvants. In: Vaccine Adjuvants: Preparation Methods and Research protocols. Humana Press. 2000:73-74.
  17. Matheis W, Zott A, Schwanig M. The role of the adsorption process for production and control combined adsorbed vaccines. Vaccine. 2001;20(1-2):67-73.
  18. Bae CS, Gwan YL, Jong SK, Byung KH. Quadrivalent Combined Vaccine, Including Diphtheria Toxoid, Tetanus Toxoid, Detoxified Whole Cell Pertussis, and Hepatitis B Surface Antigen. J Microbiol Biotechnol. 2003;13(3):338-343.
  19. Gupta RK. Aluminum compounds as vaccine adjuvants. Adv Drug Deliv Rev. 1998;32(3):155-172.
  20. Bé LV. Nhìn lại chặng đường cung cấp vắc xin cho chương trình tiêm chủng mở rộng của Viện Vắc xin và Sinh phẩm y tế. Tạp chí Y học dự phòng. 2013;9(145):9-12.
  21. Kang KR, Kim JA, Cho GW, Kang HU, Kang HM, Kang JH, et al. Comparative Evaluation of Recombinant and Acellular Pertussis Vaccines in a Murine Model. Vaccines. 2024;12(1):108.
Creative Commons License

This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License.

Copyright (c) 2025 Array