Genetic stability of master and working strain used for HAVAX® vaccine production in Vietnam

Các tác giả

  • Nguyen Thi Thuong National Institute of Hygiene and Epidemiology, Hanoi
  • Taichiro Takemura Friendship laboratory, Nagasaki research station, Nagasaki University based at NIHE
  • Nguyen Phuong Anh University of Science and Technology of Hanoi
  • Nguyen Thi Kim Dung The Company for Vaccine and Biological Production No.1 (VABIOTECH), Hanoi
  • Tran Thi Hien Friendship laboratory, Nagasaki research station, Nagasaki University based at NIHE
  • Do Tuan Dat The Company for Vaccine and Biological Production No.1 (VABIOTECH), Hanoi

DOI:

https://doi.org/10.51403/0868-2836/2021/491

Từ khóa:

HAV, hepatitis A vaccine, HM-175, NGS, Sanger sequencing

Tóm tắt

Hepatitis A Virus (HAV) is a single, positive-strand RNA virus that belongs to the Picornaviridae family, genus Hepatovirus. Its genome consists of approximately 7500 ribonucleotides. Infection with HAV can lead to hepatitis A, a short-term but highly contagious liver disease and cause big burden, especially for resource-limited settings. Vaccination against hepatitis A is the most effective prevention and control of viral hepatitis. In Vietnam, HAVAX®, a formaldehyde-inactivated vaccine derived from the HAV p16 HM-175 strain, is produced by the Company for Vaccine and Biological Production No.1 (VABIOTECH). The production of a vaccine requires the master and working seed systems and one of the requirements of vaccine strain is its genetic stability. However, up to now, the complete genome of HAV strains used in HAVAX® vaccine have never been identified by the manufacturer. This study investigated the genetic stability of the VABIOTECH HAV working strain by next-generation (NGS) and Sanger sequencing techniques. The complete consensus assemblies of both master and working strains were obtained. Analysis of genetic stability of the working strain compared with its master strain at nucleotide and amino acid levels showed an absolute homogeneity in both coding and non-coding regions ensuring the genetic qualification for the HAVAX® vaccine production.

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Đã Xuất bản

18-02-2022

Cách trích dẫn

Thuong, N. T. ., Takemura, T. ., Anh, N. P. ., Dung, N. T. K. ., Hien, T. T. ., & Dat, D. T. . (2022). Genetic stability of master and working strain used for HAVAX® vaccine production in Vietnam. Tạp Chí Y học Dự phòng, 31(10), 28–39. https://doi.org/10.51403/0868-2836/2021/491

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