The excretion rate and stability of HAAg in human fecal samples after live attenuated hepatitis A vaccination

The live attenuated hepatitis A virus vaccine (HA-L) is in routine use in the Chinese national immunization program (NIP). The major disadvantages of HA-L include that theoretically, it may be possible for mutation shifts and secondary infections of the live vaccine viral strain. The aim of this study was to explore variation in the viral strain after vaccination with the HA-L. A total of 1297 fecal samples (including 470 for the 18 to 36-month-old age group, 527 for the 3 to 16-year-old group, and 300 for the 16 years and older group) were collected in the study, and the rate of hepatitis A virus (HAV) positivity in fecal samples was 11.36% (31/273), 11.44% (31/271), 9.70% (26/268), 8.47% (21/248), and 9.70% (23/237) on days 0, 7, 14, 21 and 28, respectively. A total of 77 HAV positive samples were randomly selected for VP1/2A (360 bp, 2218-2577) gene analysis. Phylogenetic trees were then constructed by the neighbor-joining method. Phylogenetic analyses showed that all the isolated HAV strains belonged to sub-genotype IB, which was the same as the vaccine strain. Compared with the vaccine strain, HM-175/7MK-5 (M16632.1), there were only two base mutations discovered, at 2291 and 2568. However, the amino acid mutation analysis showed that those base mutations were synonymous mutations. The isolated HAV strains were genetically stable. This study provides a reference for the safety concern regarding the routine and wide-range use in people older than 18 months.