EVALUATE THE QUALITY OF BCG VACCINE PRODUCTION STRAINS BY GENE SEQUENCING METHOD

Abstract

BCG is recognized as the most effective vaccine for preventing tuberculosis today. It is one of the six initial vaccines included in the nationwide expanded immunization program since 1986. Currently, the BCG vaccine is produced in Vietnam with strict requirements from strain selection to preservation. This study aims to investigate and assess the stability of the 16S rRNA gene of the production strain BCG lot 1173P2 Lot c/WS4 and the master strain BCG 1173P2 secondary seed-Lot C from the manufacturer IVAC at the National Institute for Control of Vaccine and Biologicals (NICVB). Using a cross-sectional research method, we determined the 16S rRNA gene sequences of the production strain BCG lot 1173P2 Lot c/WS4 and the master strain BCG 1173P2 secondary seed-Lot C, which were found to be 99% and 100% identical, respectively, to the gene sequence of the Mycobacterium bovis BCG Pasteur 1173P2 strain in the International Genomic Data Bank. The results of this study demonstrate the stability of the 16S rRNA gene of the production strain BCG 1173P2 and provide a foundation for the application of gene sequencing methods for identification testing, serving the quality control of BCG vaccines in particular and other vaccines and biological products in general at NICVB