Study on the stability of gene sequences of seed lot system G4P6 (2001019203) during production of rotavirus vaccine

ABSTRACT

Background: Currently, the World Health Organization is encouraging developing countries to establish a seed lot system of rotavirus vaccine for production of this vaccine. Objectives: To determine gene sequences of rotavirus strain that was used for vaccine production and to evaluate its stability. Materials and method: Master seed (G4P6MS), Working seed (G4P6WS) and vaccine strain (G4P6VX) of Rotavirus were used for analysis at the US Center for Disease Control and Prevention (CDC). Results: 855 base pairs of gene 4 (VP4); 1195 base pairs of gene 6 (VP6); 824 base pair of gene 9 (VP7) and 715 base pairs of gene 10 (NSP4) from seed lot system and vaccines of G4P6 strain were determined. The results demonstrated this seed lot system is completely stable during vaccine production. There is no difference for nucleotide and amino acid sequence in this seed lot system. Conclusion: G4P6 strain (2001019203) is completely stable during vaccine production.