Effect of pre-inactivation filtration on structural proteins and immunogenicity of enterovirus 71 inactivated vaccine
10.13200/j.cnki.cjb.004675
- VernacularTitle:肠道病毒71型灭活疫苗灭活前过滤对病毒结构蛋白及免疫原性的影响
- Author:
Dou ZHANG
1
Author Information
1. Wuhan Institute of Biological Products Co., Ltd., Wuhan 430207, Hubei Province, China
- Publication Type:Journal Article
- Keywords:
Enterovirus 71(EV71);
Filtration process;
Recovery rate;
Immunogenicity
- From:
Chinese Journal of Biologicals
2026;39(04):397-402
- CountryChina
- Language:Chinese
-
Abstract:
Objective To optimize the filtration process before inactivation in the preparation of enterovirus 71(EV71)inactivated vaccine, screen high recovery filters, and evaluate their effects on viral structural proteins and immunogenicity.MethodsBy comparing the recovery rates of feed solution, antigen, and protein processed by four different filters, the optimal filter was selected. SDS-PAGE and Western blot were used to analyze the changes in viral structural proteins before and after filtration. The prepared bulk solution and aluminum hydroxide adjuvant were adsorbed and divided into five groups to intraperitoneally immunize female BALB/c mice, including unfiltered high-dose group(4. 5 μg/dose), unfiltered low-dose group(1. 5 μg/dose), filtered high-dose group, filtered low-dose group and blank control group(1. 05 mg/dose aluminum hydroxide adjuvant), with 10 mice in each group. The mice were immunized twice on day 0 and day 14. Blood samples were collected on day 0(before immunization), day 14 and day 28. The neutralizing antibody titer of immunized animals was detected by micro cytopathic inhibition method, and then the effect of filtration process on virus immunogenicity was evaluated.ResultsFilter 2 exhibited the highest antigen and protein recovery rates among the four filters, at 96. 10% and94. 64%, respectively. There was no significant difference in the proportion of viral structural proteins(VP0, VP1, VP2, VP3)before and after filtration(t = 1. 527, 0. 693, 1. 113 and 2. 416, P = 0. 201, 0. 526, 0. 328 and 0. 073, respectively). There was no significant difference in immunogenicity of EV71 vaccine before and after filtration on day 14 and day 28 between the low-dose groups as well as the high-dose groups(low-dose groups: t = 1. 067 and 0. 574, P = 0. 300 and 0. 573, respectively;high-dose groups: t = 0. 249 and 0. 110, P = 0. 806 and 0. 914, respectively), indicating that the addition of filtration process had no effect on the immunogenicity of EV71 vaccine.ConclusionAdding a filtration process before inactivation has no effect on virus structure and immunogenicity, which meets the requirements of WHO for vaccine safety.
