2022年10期目次

  • Progress in development and application of quadrivalent influenza virus vaccine

    WU Ye-hong;ZHANG Xue-mei;Changchun Institute of Biological Products Co.,Ltd.;

    Influenza is a global infectious disease caused by influenza virus with universal susceptibility in humans.Influenza viruses are classified as types A,B,C and D according to the differences in nucleoprotein(NP) and matrix protein,among which types A and B mainly cause infections in humans. In most influenza seasons,influenza A virus causes the majority of influenza cases,which is considered to pose a greater risk of causing an influenza pandemic.However,influenza B virus also causes a huge public health burden,especially in high-risk groups such as children and the elderly. In addition,since the influenza season from 2001 to 2002,two lineages of influenza B,B/Victoria and B/Yamagata,have changed from alternating epidemics into co-epidemics. When the antigen components of influenza B vaccine are not matched to those of the epidemic strains,the ability of traditional trivalent influenza vaccine in inducing effective protection is limited or in lack. Therefore,in 2012,WHO recommended the substitution of quadrivalent antigen for trivalent antigen as the influenza vaccine component,that is introduction of type B antigen of another lineage.Quadrivalent influenza vaccine(QIV) is helpful to overcoming difficulties in predicting circulating B lineage strains and selecting the components of influenza B vaccines,thereby indirectly improving protective efficacy of the vaccine. At present,QIV from various manufacturers at home and abroad have been marketed,which are mainly classified as inactivated egg/MDCK cells-based vaccine,live attenuated egg-based vaccine and genetic recombinant hemagglutinin(HA)vaccine according to the technical routes of vaccine preparation. This paper reviews the progress in development and application of QIV by various technical routes,in view to providing a reference for the prevention and control of influenza as well as development and application of influenza vaccines.

    2022 10 v.35 [Abstract][OnlineView][Download 838K]

  • Preparation and immune effect of inactivated porcine Erysipelothrix rhusiopathiae and Streptococcus suis combined oil emulsion vaccine

    HAN Ye-qin;CUI Li-rong;XING Gang ;HE Chang-sheng ;SUN Pei;LIU Xue-lan;WEI Jian-zhong;LI Yu;College of Animal Science and Technology,Anhui Agricultural University;

    Objective To prepare an oil emulsion-inactivated E. rhusiopathiae(ER)and Streptococcus suis(SS)combined vaccine and evaluate its immune effect. Methods Serotype 1a ER(code AEr31)and type 2 SS(SS2,code HF2)were used as vaccine strains,while formaldehyde as inactivating agent and ISA 201VG mineral oil as adjuvant. Inactivated whole bacteria(V-AEr31,V-HF2) and adjuvant were mixed by two modes,and the prepared emulsion-inactivated vaccines(V-AEr31 + V-HF2)+ ISA 201VG and(V-AEr31 + ISA 201VG)+(V-HF2 + ISA 201VG)were tested for properties,sterility and safety. Mice were divided into groups Ⅰ and Ⅱ,and immunized with inactivated vaccines(V-AEr31 + V-HF2)+ ISA201VG and(V-AEr31 + ISA 201VG)+(V-HF2 + ISA 201VG)by subcutaneous injection in several sites,using 0. 9% sodium chloride solution as control(group Ⅲ). The titer of IgG and contents of related cytokines(IL-4,IL-10,IFNγ,TNF-βand MCP-1) in sera of mice were determined by indirect ELISA,while the level of functional antibody by serum germicidal test,the splenic lymphocyte proliferation index(SI)by MTT assay,and the percentage of T lymphocyte subsets in CD4~+ and CD8~+ peripheral blood by flow cytometry. The immune protection rate was determined by intraperitoneal challenge test,while the colonization of challenge strain in vivo by the number of bacteria loaded in tissue. The lung,liver,spleen and kidney of mice were prepared into pathological sections and observed for pathological change. Results The two inactivated vaccine were qualified in tests for properties,sterility and safety. The serum IgG titer,functional antibody level,related cytokine content,SI as well as the percentage of T lymphocyte subsets in CD4~+ and CD8~+ peripheral blood were significantly higher in groupsⅠand Ⅱ than in group Ⅲ(each P < 0. 05),while showed no significant difference in groupsⅠand Ⅱ(each P > 0. 05). Both the protective rates of the two inactivated vaccines to mice were 100%,while the bacterial colonization levels in lung,liver,spleen and kidney of mice in groups Ⅰ and Ⅱ were significantly lower than those in group Ⅲ(P < 0. 05). The pathological changes in various organs were mild. Conclusion The oil emulsion inactivated ER-SS2combined vaccines prepared by two mixing methods induced good humoral and cellular immunities in mice,100% of which protected the mice against challenge with virulent ER,SS2 and ER-SS2 strains.

    2022 10 v.35 [Abstract][OnlineView][Download 1598K]

  • Mechanism of effect of CDCA7 on occurrence and development of esophageal squamous cell carcinoma through regulating expression of CCNB1IP1

    LI Hong-yi;WENG Yong-jia ;GUO Ding-he ;WANG Shao-jie ;CHENG Xiao-long;Translational Medicine Research Center,Shanxi Medical University;

    Objective To investigate the effect of CDCA7 on the ability of proliferation of esophageal squamous cell carcinoma(ESCC)cell lines KYSE450,KYSE150 and KYSE180 in vitro,and further analyze the mechanism of CDCA7in promoting ESCC cell proliferation. Methods CDCA7 in KYSE150 and KYSE450 cell lines was knocked down with CDCA7-siRNA,and exogenously expressed in KYSE180 cell line by using overexpression vector,of which the knockdown and overexpression efficiencies were determined by qRT-PCR and Western blot. The effect of CDCA7 on the proliferation of ESCC cells in vitro was determined by CCK8 and hard clone assays,the downstream target genes regulated by CDCA7 were identified by chromatin immunoprecipitation sequencing(ChIP-sequencing),while the m RNA expression levels of CCNB1IP1 in knockdown and overexpression cell lines by qRT-PCR,and the protein expression levels by Western blot. The correlation of CDCA7 with CCNB1IP1 mRNA expression level was analyzed by using the transcriptome data in TCGA database,and the regulatory effect of CDCA7 on CCNB1IP1 transcription was verified by dual luciferase reporter assay. Results CDCA7 was highly expressed in ESCC tissue,and the prognosis of ESCC with increased CDCA7 expression was poor. Knockdown of CDCA7 significantly inhibited the proliferation of ESCC cells,while overexpression of CDCA7 significantly promoted the proliferation of ESCC cells. CDCA7 positively regulated the CCNB1-IP1 expression at transcription level thus influenced the protein expression level of CCNB1IP1. Conclusion CDCA7 influenced the CCNB1IP1 protein expression level by regulating the CCNB1IP1 expression at transcription level thus regulated the proliferation of ESCC cells as well as the occurrence and development of ESCC.

    2022 10 v.35 [Abstract][OnlineView][Download 1304K]

  • Bioinformatics of human aconitate decarboxylase 1 gene and its encoded protein

    WANG Tao;SUN Xin;JIANG Pei-jia;XIAO Jin-ren;LI Ling;Pharmacy School,Hunan University of Chinese Medicine;

    Objective To analyze the transcription regulation factors of human aconitate decarboxylase 1(ACOD1)gene and the molecular function of human ACOD1 protein. Methods The transcription factor binding site,methylated CpG site and single nucleotide polymorphism(SNP)site in promoter region of human ACOD1 gene were predicted by a variety of bioinformatics software,and Gene Onotology(GO) function annotation and protein interaction network analysis of human ACOD1 protein were performed. Results There were 3 promoter sequences,17 transcription factor binding sites,no methylated CpG sites and 12 SNP sites in the promoter region of human ACOD1 gene. Human ACOD1 protein showed multiple molecular functions and participated in various biological processes,which might interact with proteins including interleukin-1β(IL-1β),C-C motif chemokine-4(CCL-4),interferon regulatory factor 1(IRF1),C-X-C motif chemokine10(CXCL10). Conclusion This study provided a reference for further research on the understand the regulatory mechanism of expression as well as the biological function of human ACOD1 gene and protein,and was helpful to the investigation on the regulatory mechanism in inflammatory response,pathogen infection,and other complex diseases.

    2022 10 v.35 [Abstract][OnlineView][Download 1186K]

  • Effect of yeast extract FM888 on growth of CHO cells

    WAN Ying-zhi;LI Qiu-xia;ZHANG Hong-qi ;ZOU Kun;XIAO Meng;WU Ye-xu ;ZHANG Song ;DENG Rui;College of Biological and Pharmaceutical Sciences & Hubei Key Laboratory of Natural Products Research and Development,China Three Gorges University;

    Objective To investigate the effect of yeast extract(YE) FM888 on the growth of Chinese hamster ovary(CHO)cells. Methods CHO suspension cells were cultured in EmCD CHO~? Medium supplemented with 1,2,3 and 5 g/L FM888 respectively in shake flask in batches,and counted by trypan blue staining method and cell counter,based on which the viable cell density and cell viability were calculated. CHO cells were cultured in EmCD CHO~? Medium supplemented with 1 and 2 g/L FM888 and determined for biochemical metabolism such as the contents of glucose,lactate,glutamine,glutamate and ammoniumions by biochemical analyzer as well as the activities of lactate dehydrogenase(LDH),creatine kinase(CK),alanine aminotransferase(ALT)and aspartate aminotransferase(AST)by the corresponding kits,while the cell cycle distribution and apoptosis by flow cytometry. Results The supplement of 1 and 2 g/L FM888 to culture medium promoted the growth of CHO cells and ensured the maintenance of high viable cell density and cell viability during culture. At the early stage of CHO cell culture,concentrations of glucose,lactate and ammonium ions in culture system were higher,while that of glutamine was lower,than those in blank control group,which promoted the cell metabolism and gradually decreased at the late stage of culture,while decreased the cell damage and the release of CHO cell enzymes,increased the proportion of CHO cells in S phase,promoted the cell proliferation and decreased the apoptosis rate of CHO cells. Conclusion The supplement of 1 and 2 g/L FM888 to culture medium promoted the growth,proliferation and metabolism,and maintained high cell viability of CHO cells.

    2022 10 v.35 [Abstract][OnlineView][Download 1127K]

  • Collaborative calibration of the 6th national standard for rabies immunoglobulin

    SHI Lei-tai;CAO Shou-chun;WU Xiao-hong;LI Jia;WANG Yun-peng;LI Yu-hua;National Institutes for Food and Drug Control;

    Objective To carry out assignment research on the 6th national standard for rabies immunoglobulin. Methods Ten qualified laboratories were organized for collaborative calibration of a novel standard with the 2nd international standard for rabies immunoglobulin(RAI)by mouse neutralization test(MNT)and rapid fluorescence focus inhibition test(RFFIT)respectively. A certain number of novel standards were randomly selected and determined for the pH value,while the uniformity was analyzed by ANOVA. The standards were stored at various temperatures(4,25 and 37 ℃) for various time durations(1,2,3 and 4 weeks)separately,from which three containers were taken at each time point and stored at-20 ℃ provisionally,and determined for antibody titer by RFFIT and analyzed for stability by ANOVA after all the samples were collected. Results Statistical analysis showed that the assignment of antibody titer determined by MNT was 35. 4 IU/mL with a 95% confidence limit of 32. 6 ～ 38. 2 IU/mL,while that by RFFIT was 38. 7 IU/mL with a95% confidence limit of 36. 8 ～ 40. 6 IU/mL. The geometric mean(37. 0 IU/mL)of two assignments was served as the assignment of the 6th national standard for rabies immunoglobulin, which showed good uniformity and stability.Conclusion The assignment research of the 6th national standard for rabies immunoglobulin(Lot:250011-201306)has been completed with accurate,reliable,scientific and rigorous results,which is of a great significance in the quality control of rabies human immunoglobulin products.

    2022 10 v.35 [Abstract][OnlineView][Download 945K]

  • Effect of costunolide on apoptosis of hepatocellular carcinoma SMMC-7721 cells and relevant mechanism

    LIU Dan;ZHANG Yong-hui;HE Xiu-zhen;XIONG Shu;MA Ling;FENG Bin-bin;FENG Xiao-ling;Chongqing Three Gorges Medical College,Chongqing Key Laboratory of Development and Utilization of Genuine Medicinal Materials in Three Gorges Reservoir Area;

    Objective To investigate the effect of costunolide(Cos)on apoptosis of hepatocellular carcinoma SMMC-7721cells and the relevant mechanism. Methods SMMC-7721 cells were randomly divided into one control and three test groups. The cells in control group were untreated,while those in three test groups were treated with 10,20 and 30 μmol/L Cos respectively. The effect of Cos on apoptosis of SMMC-7721 cells were evaluated by flow cytometry,while the expression levels of apoptosis-related proteins(Bax,Bcl-2 and Caspase-3)and endoplasmic reticulum stress(ERS)pathwayrelated proteins(GRP78,CHOP and ATF4) were determined by Western blot. Results The apoptosis rates(ARs) of SMMC-7721 cells in three test groups were significantly higher than that in control group(P < 0. 05) and increased significantly with the increasing Cos dose(P < 0. 01). Compared with those in control group,the expression levels of Bcl-2protein in SMMC-7721 cells treated with 20 and 30 μmol/L Cos decreased significantly(P < 0. 05),while those of Bax protein increased significantly(P < 0. 05),and those of Bcl-2 and Bax proteins in the cells treated with 10 μmol/L Cos showed no significant difference(P > 0. 05). However,there was no significant difference in the expression level of Caspase-3 protein in SMMC-7721 cells in various groups(P > 0. 05),and the expression levels of GRP78,CHOP and ATF4 proteins in the cells treated with 10 and 20 μmol/L Cos increased significantly(P < 0. 05). Conclusion Cos promoted the apoptosis of hepatocellular carcinoma SMMC-7721 cells by activating ERS pathway.

    2022 10 v.35 [Abstract][OnlineView][Download 1036K]

  • Preparation and purification of whole human intracellular antibody against M1 protein of H5N1 avian influenza virus

    MAN Hong-yang;SUN He;TIAN Yuan ;WU Guang-mou ;ZHANG Guo-li ;QIU Yue;WANG Yu;ZHANG Wen-hui;YUE Yu-huan;College of Life Sciences,Jilin Agricultural University;

    Objective To prepare and purify the whole human intracellular antibody TAT-ScFv M1-mFc against M1 protein of H5N1 avian influenza virus(AIV). Methods The target gene fragment TAT-ScFv M1 was amplified from plasmid pET28(a)-TAT-ScFv M1 by PCR,and inserted into expression vector pET32(a)-HisTag-Sumo-mFc. The constructed recombinant expression plasmid pET32(a)-HisTag-Sumo-TAT-ScFv M1-mFc was transformed to E. coli BL21(DE3) and induced by IPTG. The expressed target protein was purified by metal chelation chromatography,Sumo digestion and affinity chromatography,and determined for affinity activity by ELISA. Results Restriction analysis and sequencing proved that the recombinant expression plasmid was constructed correctly. The recombinant protein was expressed in a form of inclusion body,with a relative molecular mass of about 80 000. The prepared intracellular antibody showed obvious binding activity to M1 protein. Conclusion A whole human intracellular antibody protein TAT-ScFv M1-mFc with affinity activity against M1 protein of H5N1 AIV was obtained,which laid a foundation of further development of antibody drugs against H5N1 AIV.

    2022 10 v.35 [Abstract][OnlineView][Download 1060K]

  • Inactivation effect of human fibrinogen by dry heat and quality change before and after inactivation

    XIE Lai-feng;ZHANG Xue-cheng;LUO Jian ;ZHANG Lun ;WANG Hai-lin;MA Xiao-wei;Research and Development Center,Hualan Biological Engineering Inc.;

    Objective To investigate the inactivation effect of human fibrinogen by dry heat and the quality change before and after inactivation. Methods Samples were taken from three batches of human fibrinogen,and added with Sindbis virus and encephalomyocarditis virus(EMCV)at a volume ratio of 9 ∶ 1 respectively,lyophilized and inactivated by dry heat at(99. 5 ± 0. 5)℃ for 30 min. The decrease of viral titer was determined by micro-CPE method on a 96-well microtiter plate to evaluate the inactivation effect of dry heat. The samples before and after inactivation were subjected to the inspection on visible foreign matters,tests for stability,purity and coagulation activity,SDS-PAGE,high performance liquid chromatography-size exclusion chromatography(HPLC-SEC),circular dichroism spectrum,fluorescence spectrum and differential scanning fluorimetry(DSF)to evaluate the quality change. Results After the three batches of samples were heated for 30 min,the titers of Sindbis virus decreased by 6. 13,5. 88 and 6. 00 LgTCID50/0. 1 mL,while the EMCV titers decreased by not less than 4. 94,not less than 4. 68 and not less than 5. 00 LgTCID50/0. 1 mL respectively. All the three batches of samples before and after inactivation were qualified for inspection on visible foreign matters and test for stability. Protein bands with relative molecular masses of about 65 000,about 56 000 and about 47 000 were observed on SDS-PAGE profiles of samples before and after inactivation. The mean purities of samples before and after inactivation were(87. 7 ± 0. 9)% and(87. 7 ± 1. 5)%,while the mean activities were(18 ± 0. 8)and(18 ± 0. 5)s,mean HPLC purities were(86. 16 ± 1. 60)% and(86. 36 ± 0. 67)%,the maximum mean fluorescence spectra were(341. 9 ± 0. 2)and(342. 1 ± 0. 2)nm,the mean mid point temperatures of thermal thansition 1(Tmid 1) were(47. 84 ± 0. 09) and(47. 36 ± 0. 36)℃,and the mean Tmid 2 were(52. 34 ± 0. 15)and(52. 19 ± 0. 33)℃,respectively,which showed no significant difference(P > 0. 05). However,the mean proportions of α helix,β sheet,β corner and random coli in samples before and after inactivation showed no significant difference(P > 0. 05). Conclusion Dry heat was effective for inactivation of human fibrinogen,and the quality of samples remains unchanged before and after inactivation.

    2022 10 v.35 [Abstract][OnlineView][Download 1200K]

  • Preparation of antibody against Japanese encephalitis virus NS1 protein and development and validation of an ELISA method for antigen quantification

    LUO Na;QIAO Jian;ZHENG Jia-wei;ZOU Wen-qi;JIANG Zhi-jun;ZHANG Zhong-kai;WU Jie;XU Ge-lin;Wuhan Institute of Biological Product Co.Ltd.;

    Objective To prepare polyclonal and monoclonal antibodies against non-structural protein NS1 of Japanese encephalitis virus(JEV),and develop a double antibody sandwich ELISA for antigen quantification and quality control in JEV vaccine development. Methods Recombinant protein JEV-NS1 was expressed in prokaryotes and purified,with which BALB/c mice and rabbits were immunized to prepare mouse monoclonal and rabbit polyclonal antibodies respectively. An ELISA method for antigen quantification was developed using rabbit polyclonal antibody and HRP-JEns1C1 mouse monoclonal antibody as capture and detection antibodies,and mouse monoclonal antibody JEns1C1 and enzymelabeled rabbit polyclonal antibody as captue and detection antibodies,respectively,in which the antigen concentration for coating and antibody concentration for detection were optimized by matrix titration. The developed ELISA method was determined for linear range and sensitivity,and validated for specificity,accuracy,precision and durability. Results Rabbit polyclonal and mouse monoclonal antibodies against JEV-NS1,with good specificity and high titer,were prepared.An ELISA method for antigen quantification was developed using rabbit polyclonal antibody as capture antibody and HRPJEns1C1 mouse monoclonal antibody as detection antibody,of which the detection range was 250. 0～4 000. 0 ng/mL,with a R~2 value of not less than 0. 99. The recoveries of samples at high(2 000. 0 ng/mL),moderate(1 000. 0 ng/mL)and low(500. 0 ng/mL) concentrations in validation for accuracy were 83. 7%～103. 4%,while the coefficients of variation(CVs)were 5. 8%,3. 8% and 2. 9% in validation for reproducibility,5. 7%,5. 8% and 5. 3% in validation for intermediate precision,and 3. 7%,5. 7% and 5. 3% in validation for durability,respectively. However,the result of validation for specificity showed that only JEV-NS1 antigen was recognized by the method,and no cross-reactions with other viruses were observed. All the validation results met the requirements for quality control of JEV vaccine. Conclusion The developed double antibody sandwich ELISA method for JEV-NS1 antigen quantification shows good specificity,accuracy,precision,linearity and durability,which may be used for antigen determination of samples in purification process,and provides a quality control method for determination of antigen content in the preparation of JEV vaccine.

    2022 10 v.35 [Abstract][OnlineView][Download 1274K]

  • Meta-analysis on risk factors of severe hand-foot-mouth disease

    DENG Peng;LI Qiong;QIAN Xiao-ai;ZHAN Fa-xian;YANG Bei-fang;Hubei Provincial Center for Disease Control and Prevention;

    Objective To investigate the risk factors of occurrence of severe hand-foot-mouth disease(HFMD) and provide a scientific basis for the prevention and treatment of the disease. Methods The data on case-control studies on risk factors of severe HFMD in China in recent years were subjected to Meta-analysis by using Stata11.0 software.Results A total of 19 literatures were included,in which 3 849 severe cases(case group) and 7 332 common cases(control group)were investigated. The scores for qualities of the literatures were not less than 5. There were eight major risk factors,i.e. age of less than 3 years,rural residents,scattered children,undiagnosed as HFMD in first visit,poor mental status,fever lasting for more than 3 d,fever of more than 39 ℃ and EV71 infection,of which the ORs and 95%CIs were(5. 16,4. 06 ～ 6. 56),(2. 46,1. 72 ～ 3. 51),(1. 33,1. 05 ～ 1. 69),(3. 02,2. 29 ～ 3. 99),(23. 63,7. 96 ～70. 15),(4. 23,2. 35 ～ 7. 61),(2. 49,1. 83 ～ 3. 40),(7. 05,4. 58 ～ 10. 86)respectively. Conclusion There are many risk factors affecting the incidence of severe HFMD,which should be prevented and controled in various aspects.

    2022 10 v.35 [Abstract][OnlineView][Download 1236K]

  • Development and verification of reversephase high performance liquid chromatography for determination of protein purity of recombinant human interleukin-12 injection

    WANG Yan-na;MENG Jin;LIU Zhong-kai;WANG Yuan-yuan;WU Ming-yuan;WANG Jian-gang;Kanglitai Biomedical(Qingdao)Co.,Ltd;

    Objective To develop and verify a method of determination of protein purity of recombinant human interleukin-12(rhIL-12)injection by reversephase high performance liquid chroomatography(RP-HPLC). Methods YMC C4gel column(250 mm × 4. 6 mm)was adopted. The mobile phase A was 0. 05% trifluoroacetic acid-water,while the mobile phase B was 0. 05% trifluoroaceticacid-acetonitrile. Gradient elution was adopted at a flow rate of 1. 0 m L/min. The column temperature was 30 ℃,while the detection wavelength was 280 nm,and the sample load was 1 000 μL. The developed RP-HPLC method was verified for specificity,precision and durability,and determined for limit of detection(LOD)and limit of quantitation(LOQ). The protein purities of three batches of rhIL-12 injection were determined by the developed method. Results The retention time of rhIL-12 injection was 16. 957 min,with a single target peak within the integral range,while no absorption peak of blank solvent(mobiles A and B and buffer) was observed. The separation degree of degradation peak of foreign protein and target peak was 2. 58,while the number of theoretical plates was 17 666. All the relative standard deviations(RSDs) of retention time,area and percentage of major peaks of rhIL-12 injection in sixconsecutive sample loadings by the same person and by different persons were less than 2. 0%. The RSD of percentages of major peaks determined at flow rates of 0. 9,1. 0 and 1. 1 mL/min was 0. 05%,while that at column temperatures of28,30 and 32 ℃ was 0. 09%. The LOD and LOQ of the developed method were 0. 06 and 0. 58 μg respectively. The protein purities of rhIL-12 injection with lot numbers of 201807002,201807004 and 201808006 were 99. 88%,99. 00%and 99. 53% respectively. Conclusion The developed RP-HPLC method showed good specificity, precision and durability,which was simple,accurate,and was suitable for the determination of protein purity of rhIL-12 injection at a concentration of 15 μg/mL.

    2022 10 v.35 [Abstract][OnlineView][Download 1327K]

  • Development of purification process for supercoiled configuration of DNA vaccine against S protein of SARS-CoV-2

    WANG Xue-yun;WU Yan-ping;YE Cai-wen;LIANG Fu;HUANG Zhi-xiang;XU Er-zan;LIU Ai-he;GUO Tu-jing;Shenzhen Weiguang Biopharmaceutical Co.,Ltd.;

    Objective To develop a purification process for supercoiled configuration of DNA vaccine pDRVI3.0-S against S protein of severe acute respiratory symptom coronavirus 2(SARS-CoV-2). Methods The ammonium sulfate concentration(2. 0,2. 3 and 2. 5 mol/L),sodium chloride concentration(0,0. 3 and 0. 5 mol/L) and sample load(1. 0,1. 5 and 2. 0 g/L) for affinity chromatography of plasmid DNA were optimized by orthogonal test using supercoiled configuration content and plasmid recovery of pDRVI3. 0-S as indicators. Results The optimal ammonium sulfate concentration,sodium chloride concentration and sample load were 2. 3 mol/L,0. 5 mol/L and 1 g/L respectively,at which the supercoiled configuration content of DNA vaccine pDRVI3. 0-S reached a maximum of more than 92%. Conclusion The purification process for supercoiled configuration of DNA vaccine pDRVI3. 0-S against S protein of SARS-CoV-2 was successfully developed,which provided a experimental basis for large-scale production of the vaccine.

    2022 10 v.35 [Abstract][OnlineView][Download 1259K]

  • Application of one dimensional nuclear magnetic resonance hydrogen spectrum in quality control of pneumococcal polysaccharide conjugate vaccine

    ZHANG Fan;CAO Fang;CHEN Ya-ru;JIANG Su;WANG Bo-ya;CHEN Gao-feng;YANG Yan;YU Zheng-rong;AIM Explorer Biomedical Research Co.,Ltd.;

    Objective To investigate the application of one dimensional nuclear magnetic resonance hydrogen spectrum(~1H-NMR) in quality control of pneumococcal polysaccharide conjugate vaccine. Methods The structures of purified polysaccharide,degraded polysaccharide,activated polysaccharide,polysaccharide derivative and bulk of polysaccharide conjugate of types 9V,14,6A and 11A pneumococcus were characterized by ~1H-NMR,and the characteristic groups were compared. Results The structures of fingerprint areas of degraded polysaccharide,activated polysaccharide,polysaccharide derivative and bulk of polysaccharide conjugate of types 9V,14,6A and 11A pneumococcus were consistent with that of standard pneumococcal polysaccharide,indicating no impact on the integrity of polysaccharide structure during degradation,activation and derivation. Conclusion ~1H-NMR method may be used for the characterization of structure of pneumococcal polysaccharide including those during degradation,activation and derivation,which is more effective in the quality control of pneumococcal polysaccharide conjugate vaccine.

    2022 10 v.35 [Abstract][OnlineView][Download 1418K]

  • Progress in research on dendritic cell vaccines

    LI Xing-hang;LI Qi-han;Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Diseases,Institute of Medical Biology,Chinese Academy of Medical Science & Peking Union Medical College;

    Objective Dendritic cell(DC)is a powerful class of antigen-presenting cells and a key step in adaptive immune response,which is necessary for the induction of T-and B-cell-mediated cellular and humoral immunities.Because of specific immunological function,DC have been paid more attention in the research on DC vaccines. A DCbased vaccine,Sipuleucel-T,has been approved for marketing,and several other DC vaccines are in clinical trials. This paper reviews the biological characteristics and functions of DC as well as the types,challenges and prospect of DC vaccines.

    2022 10 v.35 [Abstract][OnlineView][Download 1392K]

  • Progress in research on application of human immunoglobulin for intravenous injection in indications and off-label indications

    ZHU Li-yuan;YE Sheng-liang;MA Li;LI Chang-qing;Institute of Blood Transfusion,Chinese Academy of Medical Sciences;

    Human immunoglobulin for intravenous injection(IVIG),an important human immunoglobulin product,is widely used in the prevention and treatment of a variety of diseases. At present,there are eight indications for IVIG approved by the Food and Drug Administration(FDA),while only four by the China Food and Drug Administration(CFDA). However,due to the limitation of content of instruction as well as hysteresis and complexity of the revision,IVIG is more commonly used for the treatment of off-label indications in actual clinical diagnosis and treatment at home and abroad. Therefore,this paper reviews the progress in research on application of IVIG in indications and off-label indications,in order to deeply understand the application of IVIG in off-label indications at home and abroad and provide a reference for the rational use of IVIG.

    2022 10 v.35 [Abstract][OnlineView][Download 1489K]

  • Application of surface modification of nanoparticles in development of vaccine adjuvants

    ZHOU Jia;SHEN Li-juan;LIU Ye;Department of Pathology,College of Basic Medicine,Kunming Medical University;

    Vaccination is an effective way to prevent infectious diseases. Vaccines enhance immunity and make indivi-duals resistant to pathogen infection. Though protein subunit vaccine has a good safety,its low immunogenicity makes adjuvant necessary to boost the immune response. As a key factor of increasing immune response of vaccine,the design concept and construction principle of adjuvants are very important for development of effective vaccines. Surface modi-fication can confer prespecified immunomodulatory function on nanomaterial to optimize immune response induced by vaccine. This paper reviews the application of surface modification of nanoparticles in development of vaccine adjuvant.

    2022 10 v.35 [Abstract][OnlineView][Download 1324K]

  • Progress in research on human respiratory syncytial virus vaccine

    LI Hai;REN Hu;ZHANG Yan;XU Wen-bo;National Institute for Viral Diseases Control and Prevention,China CDC,NHC Key Laboratory of Medical Virology and Viral Diseases,WHO WPRO Regional Reference Measles/Rubella Laboratory;

    Human respiratory syncytial virus(hRSV)is one of the major causes of severe respiratory diseases in infants and the elderly,and the global economic burden caused by hRSV infection is estimated to exceed $80 billion annually.Since the discovery of hRSV in 1950s,extensive research and development have been carried out on hRSV vaccine at home and abroad,though there is still no hRSV vaccine approved. The vaccine has been facing great challenges such as insufficient safety or weak immunogenicity,and several hRSV vaccines have been declared “failures” in clinical trials. In2013,the conformation of prefusion F protein(Pre-F)was successfully analyzed,and then hRSV vaccines based on PreF showed good application prospects. At present,there are 14 vaccines in clinical trials,including live attenuated vaccine,viral carrier vaccine,subunit vaccine and granule vaccine. In this paper,the challenge and the latest progress in research of hRSV vaccine are reviewed.

    2022 10 v.35 [Abstract][OnlineView][Download 1481K]

  • Progress in research on multivalent Streptococcus pneumoniae capsular polysaccharide-protein conjugate vaccine

    TIAN Yu;MA Ke;SU Xiao-ye;Beijing Zhifei Lvzhu Biopharmaceutical Co.,Ltd.;

    Streptococcus pneumoniae is one of the pathogenic bacteria causing extremely high morbidity and mortality,which seriously threatens human life and health. The capsular polysaccharide of S. pneumoniae is immunogenic,which may stimulate the production of protective antibody. However,capsular polysaccharide vaccines can not induce immune memory antibody alone. The polysaccharide combined with carrier protein may induce immune memory antibody and effectively improve the immunogenicity of vaccine to prevent the invasive disease of S. pneumoniae. At present,heptavalent,decavalent and 13-valent S. pneumoniae polysaccharide-protein conjugate vaccines(pneumococcal conjugate vaccines) have been developed successively,while 15-and 20-valent pneumococcal conjugate vaccines are also in clinical trials. This article reviews the progress in research on development,preparation methods,influencing factors of immunogenicity and vaccination status in China of pneumococcal conjugate vaccine.

    2022 10 v.35 [Abstract][OnlineView][Download 1438K]

  • Progress in research on mechanism of let-7a and its target genes in hepatocellular carcinoma

    LIANG Yu;SHEN Tao;The Affiliated Hospital of Kunming University of Science and Technology,The First People′s Hospital of Yunnan Province;

    Hepatocellular carcinoma(HCC)is one of the most aggressive malignant tumors in the world,with high recurrence rate and mortality. In most malignant tumors,microRNAs(miRNAs)have been found to be abnormally expressed,thus affect the occurrence,development,metastasis and recurrence of tumors,which play a regulatory role in life activities such as the occurrence and development of diseases,biological development,organ formation,virus defense,epigenetic regulation and metabolism by targeting various target genes and participating in various signaling pathways. Let-7 is a miRNA. As a member of let-7 family,let-7a is involved in biological processes such as cell proliferation and apoptosis and plays the role of tumor suppressor in a variety of cancers. Therefore,this paper reviews the mechanism of let-7A and its target genes in HCC.

    2022 10 v.35 [Abstract][OnlineView][Download 1398K]


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