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Objective:To evaluate the immunogenicity of a quadrivalent subunit vaccine combined with RFH01 adjuvant in a mouse model.Methods:Identification tests were performed on four monovalent influenza virus subunit vaccine stock solutions according to the methods described in Part 3 of the Chinese Pharmacopoeia 2020 Edition. In the study of the quadrivalent subunit vaccine combined with RFH01 adjuvant, 460 female BALB/c mice (6-8 weeks old) were randomly divided into 46 groups including experimental groups, vaccine control group, negative control group and blank group with 10 mice in each group. In the study of the quadrivalent subunit vaccine in old and young mice, 80 female 10-month-old and 80 female 10-week-old BALB/c mice were randomly divided into 16 groups ( n=10) including monovalent influenza virus vaccine group, quadrivalent subunit vaccine group, quadrivalent subunit vaccine+ RFH01 adjuvant group, chicken embryo quadrivalent split vaccine control group and PBS group. All mice were immunized by intramuscular injection. At 21 d after the primary immunization, a booster immunization was conducted using the same strategy. Blood samples were collected at 21 d and 42 d after the primary immunization for serum separation. Haemagglutination inhibition (HI) test was performed to detect the antibody levels in mouse serum samples. Results:After the booster immunization, the positive conversion rates in all vaccine+ RFH01 adjuvant groups reached 100%, and the geometric mean titers (GMTs) of serum antibodies were significantly higher than those of the vaccine groups without RFH01 adjuvant. There were significant differences in serum antibody titers between the monovalent/quadrivalent subunit vaccine groups with and without RFH01 adjuvant. After the booster immunization, the titers of serum antibodies against H1N1, H3N2, B/Victoria and B/Yamagata in the 10-week-old mice were significantly higher than those in the 10-month-old mice.Conclusions:The monovalent and quadrivalent influenza virus vaccines in combination with RFH01 adjuvant could elicit higher antibody titers in young (6-10 weeks old) and old (10 months old) mice, showing good immunogenicity.
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Objective:To investigate the antigen-sparing effects of crude polysaccharides from Cistanche deserticola Y. C.Ma (CPCD) for influenza virus vaccine (IVV). Methods:ICR mice were immunized subcutaneously with CPCD combined with different doses of IVV (0.01 μg and 0.1 μg). Hemagglutinin inhibition (HI) assay was used to detect HI titers in serum samples. Indirect ELISA was performed to detect the levels of specific IgG antibodies and their subtypes in serum samples. The proliferation of splenic lymphocytes was detected by MTT assay. The percentages of CD4 + , CD8 + and CD44 + T cells and the levels of IFN-γ in splenic cells isolated from the vaccinated mice were analyzed by flow cytometry. Results:CPCD significantly increased HI titers (234.67±47.70 vs 149.33±47.70, P<0.05), promoted the production of IgG ( A450 value: 1.16±0.63 vs 0.30±0.21, P<0.05) and IgG1 ( A450 value: 1.09±0.60 vs 0.26±0.21, P<0.05) and enhanced splenic lymphocyte proliferation ( P<0.05). CPCD also significantly up-regulated the expression of CD4 + [(41.97±4.58)% vs (25.43±1.48)%, P<0.05], CD8 + [(12.67±0.33)% vs (9.02±1.07)%, P<0.05], CD4 + CD44 + [(11.77±0.69)% vs (8.64±0.71)%, P<0.05] and CD8 + CD44 + [(6.70±0.67)% vs (4.66±0.39)%, P<0.05] T cell subsets as well as the secretion of IFN-γ in CD4 + [(1.36±0.07)% vs (0.87±0.06)%, P<0.05] and CD8 + [(2.09±0.20)% vs (1.42±0.08)%, P<0.05] T cells. In addition, there was no significant difference between CPCD combined with low-dose IVV group and high-dose IVV alone group ( P>0.05), implying a 10-fold antigen sparing. Conclusions:CPCD, as an adjuvant for influenza virus vaccine, could enhance humoral and cellular immune responses and reduce antigen dose, which might be a potential adjuvant for seasonal or pandemic influenza vaccines.
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Objective To evaluate the safety of a Chinese thimerosal-free trivalent split influenza virus vaccine after being marketed in a large population. Methods Through the information management system of adverse event following immunization (AEFI), the adverse events in healthy people aged 6 months and above who were vaccinated with split influenza virus vaccine in Hubei Province from October to December 2015 were collected. The data was analyzed by descriptive methodology. Results From October 1, 2015 to June 30, 2016, among the 227 920 people in Hubei Province who were vaccinated with split influenza virus vaccine, the common adverse reactions were mainly fever, redness, irritability, pain and itching. Four cases of AEFI were passively observed and reported in the system, with a reporting rate of 1.76/100 000, among which 3 cases were anaphylactic rash and 1 case was optic neuritis. Conclusion The Chinese thimerosal-free trivalent split influenza virus vaccine used in Hubei Province had a good safety record and is suitable for the general vaccination of people without vaccination contraindications.
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Objective To investigate the efficacy of using Xinjiang wild Artemisia rupestris L. crude polysaccharides ( WARCP) as an immunologic adjuvant for influenza virus vaccine( IVV) .Methods ICR mice were subcutaneously immunized with 0.3 μg of IVV and 1.5 μg of IVV alone or co-administered with 200 μg of WARCP on 0 d and 14 d.Antibody levels in serum samples were detected by using indirect ELISA.MTT method was used to measure the proliferation of splenocytes.The growth conditions of mice were observed as well.Results No significant differences in the body weight were observed between mice from different groups (P>0.05).The levels of influenza virus-specific IgG, IgG1 and IgG2a were signifi-cantly increased in mice injected with WARCP adjuvant (P<0.05).The levels of IgG antibody in mice im-munized with low-dose of IVV and WARCP were significantly higher than those in mice immunized with high-dose of IVV alone (P<0.05), indicating at least 80% reduction in vaccine dosage by adding WARCP as adjuvant.Moreover, WARCP significantly promoted the proliferation of lymphocytes (P<0.05).Conclu-sion Adding WARCP to IVV enhanced the efficacy of IVV by boosting humoral and cellular immunity re-sponses with the advantages of high safety and dose-sparing.This study suggested the possibility of using WARCP as a novel immunologic adjuvant for influenza virus vaccine.
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Objective To analyze the genetic stability of master virus seed lots of live attenuated influenza vaccineA/17/California/2009/38(H1N1)andA/17/Perth/09/87(H3N2)strains.Methods The master virus seed lots were inoculated into chicken eggs for subculture.The complete genome of the 2nd, 3rd, 5th and 10th generations of viruses were amplified and sequenced.The genes encoding hemagglu-tinin ( HA) and neuraminidase ( NA) were compared with those of the WHO recommended circulating wild-type virus strains used for vaccine production in northern hemisphere during 2011-2012 influenza season.Six internal genes (PB2, PB1, PA, NP, M and NS) of each virus generation were compared with their master donor virus strain (A/Leningrad/134/17/57) for the evaluation of the genetic stability.Results The muta-tion rates of H1N1 and H3N2 strains after 10 passages were 0.035%and 0.022%, respectively.No muta-tions were found at the critical sites for controling thecold adapted ( ca) , temperature sensitive ( ts) and at-tenuated ( att) phenotypes.Conclusion The live attenuated influenza vaccine strains possessed high genet-ic stability as their tenth generations still shared 99% of homology with the original seed lots.All of the working virus seed lots met the requirements of Pharmacopoeia of the People′s Republic of China ( 2010 edition) .
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To evaluate security of influenza virus vaccines by analysis of adverse reaction to influenza virus vaccine,especially the relationship between Guillain Barr? syndrome and influenza vaccines.
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Objective To compare the safety and immunogenicity between domestic and imported,imported and imported split influenza virus vaccine in Chinese population. Methods The published studies during January 1996 and June 2008 on the comparison between split influenza virus vaccine were screened and evaluated.The meta analysis was performed on safety and immunogenicity using fixed model or random model according the heterogeneity of the studies. Results 12 studies which were all random controlled trials between split vaccine were included.10 trials were between domestic and imported vaccine,and 2 trials were between imported and imported vaccine.For 10 domestic and imported vaccine trials,the local reaction pooled OR=0.81,95% CI (0.59,1.11);the systemic reaction the pooled OR=0.78,95% CI (0.50,1.03);the H1N1 subtype seroconversion pooled OR= 0.94,95% CI (0.78,1.14);the H3N2 subtype seroconversion pooled OR =1.01,95% CI (0.87,1.17);the B type seroconversion total OR= 1.35,95% CI (0.98,1.85).For 2 imported and imported vaccine trials,the local reaction pooled OR = 1.19,95% CI (0.60,2.37);the systemic reaction the pooled OR =1.15,95% CI (0.71,1.87);the H1N1 subtype seroconversion pooled OR= 1.27,95% CI (0.37,4.37);the H3N2 subtype seroconversion pooled OR= 1.29,95% CI (0.39,4.33);the B type seroconversion pooled OR= 0.95,95% CI (0.46,1.37). Conclusions There were no statistical difference on the safety and immunogenicity between domestic and imported,imported and imported split influenza vaccine in Chinese population.