[Study on the safety and immunogenicity of simultaneous vaccination on both hepatitis E and hepatitis B vaccines]

Objective: Safety and immunogenicity regarding simultaneous vaccination on both hepatitis E and hepatitis B vaccines were studied. Methods: A total of 600 healthy subjects aged 18-60 were recruited in Chaoyang district of Beijing city, from September 2015 to December 2016. Subjects meeting the inclusion and exclusion criteria were randomly divided into 3 groups: the simultaneous vaccination group of hepatitis E and hepatitis B, the hepatitis B vaccination group and the hepatitis E vaccination group. Members of the 3 groups were all inoculated according to the procedure of '0, 1 and 6 months'. Safety and immunogenicity of the simultaneous vaccination group was compared with the individual vaccination groups. Results: Vaccination groups had 601 subjects, involved with having 150 subjects of hepatitis E vaccination group, 159 subjects of hepatitis B vaccination group, and 292 subjects of simultaneous vaccination of hepatitis E and hepatitis B. Local adverse reactions that mostly common seen, would include pain (25.0%, 73/292), redness (12.7%, 37/292), pruritus (9.2%, 27/292), callus (8.9%, 26/292), swelling (8.2%, 24/292) at the inoculation sites. Systemic adverse reactions would include fever (7.2%, 21/292), headache (5.8%, 17/292), muscle pain (5.5%, 16/292) and fatigue (3.4%, 10/292). No serious adverse reactions associated with vaccination were seen. In addition to the higher incidence of pain at the inoculation sites, rest of the adverse reactions was similar to the simultaneous vaccination group or the individual vaccination groups. One month after the completed immunization process, positive rate and geometric mean concentration(GMC) of the HBsAb were not inferior to that of the hepatitis B vaccine group (94.2% vs. 93.8%, 611.6 WU/ml vs. 745.1 WU/ml). Positive rate and GMC of the HEV IgG were not inferior to that of the hepatitis E vaccinated group (98.8% vs. 100.0%, 11.0 WU/ml vs. 18.0 WU/ml). Conclusions: Simultaneous vaccination strategy on hepatitis E and hepatitis B vaccines showed good safety and immunogenicity. It is recommended that hepatitis E and hepatitis B vaccines should be administered to the susceptible population at the same time, in order to protect the liver functions.