Immunogenicity of combined immunizing of inactivated enterovirus 71 vaccine (Vero cells) and hepatitis B, live-attenuated Japanese encephalitis vaccines respectively
ZHANG Shang-xiao1, XIA Wei1, GAO Li-dong1, ZHAN Dai-hong2, ZHANG Xiu-mei2, SONG Li-xin1, LI Fang-jun1
1. Hunan Provincial Center for Disease Control and Prevention, Changsha, Hunan 410005, China; 2. Shimen County Center for Disease Control and Prevention, Changde, Hunan 415399, China
Abstract:Objective To evaluate and explore the effects and feasibility of combined immunizing of inactivated enterovirus 71 (EV71) vaccine and recombinant hepatitis B (HepB) vaccine, live-attenuated Japanese encephalitis vaccine (LJEV)respectively so as to provide a scientific basis for combined vaccination with inactivated EV71 vaccine and vaccines covered by immunization program. Methods A randomized, controlled and multicenter study was conducted. Subjects who met the inclusion criteria were assigned study numbers by stratified block randomization, and then we evaluated the immunogenicity and operability of combined immunizing of the first dose of inactivated EV71 vaccine and the third dose of recombinant HepB vaccine (HepB:3), the first dose of LJEV respectively in infants aged 6/8 months in each group. Results The median concentration of HBsAb in the HepB:3+EV71 group and the HepB alone immunization group (HepB:3 group) before the immunization was575.19 mIU/ml and 592.97 mIU/ml, respectively, and no statistically significant difference was found (P>0.05). The median concentration in the above-mentioned two groups after the immunization was 2,766.11 mIU/ml and 2,153.63 mIU/ml, respectively, showing no statistically significant difference (P>0.05). The geometric mean titers of pre-vaccination EV71 neutralizing antibody in the EV71+LJEV group and the LJEV single immunization group (LJEV group) were 1:5.00 and 1:5.13, respectively, and no statistically significant difference was found (P>0.05). The geometric mean titers of post-vaccination EV71 neutralizing antibody in the above-mentioned two groups were 1:11.55 and 1:9.75, and the difference was not statistically significant (P>0.05). No statistically significant difference was found in the positive conversion rate of HBsAb between theHepB:3+EV71 group and the HepB: 3 group (48.08% vs. 51.85%, P>0.05). No statistically significant difference was observed in the positive conversion rate of antibody against JE virus between the LJEV+EV71 group and the LJEV group (67.92% vs. 59.26%, P>0.05). The post-vaccination EV71 neutralizing antibody showed positive conversion in all the experimental groups (the combined vaccination groups) and the EV71 group. No statistically significant difference was found in the geometric mean titer of pre-vaccination EV71 neutralizing antibody between the EV71 group and the HepB:3+EV71 group (1:4.21 vs.1:4.62, P>0.05) as well as between the LJEV+EV71 group and the EV71 group (1:4.16 vs. 1:4.21, P>0.05). The geometric mean titer of post-vaccination EV71 neutralizing antibody was higher in the HepB:3+EV71 group (1:1,169.45) and the LJEV+EV71 group (1:1,156.49) as compared with the EV71 group (1:612.93), with statistically significant differences (both P<0.05). Conclusion The positive conversion rate of post-vaccination EV71 neutralizing antibody was 100% when inactivated EV71 vaccine was inoculated either alone or combined with recombinant HepB vaccine and LJEV respectively. Combined immunization with inactivated EV71 vaccine and recombinant HepB vaccine or LJEV will not lead to a decrease in EV71 neutralizing antibody as well as the production of HBsAb and JE antibody, but will effectively improve the efficiency and timeliness of vaccination.
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