ABSTRACT
PURPOSE: There is no standard method for confirming the immunogenicity of acellular pertussis vaccines. We tried to develop a local standard method for evaluating the immunogenicity of the three-component of acellular pertussis vaccines which was developed by a Korean local company. MATERIALS AND METHODS: The developed pertussis antigens (pertussis toxin, filamentous hemagglutinin, pertactin) were evaluated by in-house enzyme-linked immunosorbent assay (ELISA) using 189 negative sera, 25 positive sera, and 73 paired sera (pre- and post-Tdap [tetanus, diphtheria, and acellular pertussis] vaccinated sera). ELISA units were calculated by the reference line method, compared with World Health Organization reference sera, and the cut-off value was calculated using negative sera. RESULTS: When compared to National Institute for Biological Standards and Control control antigen (NIBSC) control antigens, the developed pertussis toxin (PT) and filamentous haemagglutinin (FHA) antigens were 203.48 and 61.60 IU/µg, respectively. Each in-house ELISA was established by validating the coefficients of variation % (PT, 11.53%; FHA, 8.60%; pertactin [PRN], 9.86%) obtained from the results of inter- and intra-assay variation. Also, the cut-off values of PT, FHA, and PRN were 11.65, 38.95, and 5.66 EU/mL, respectively. The distributions of antibody levels in paired showed that 93.15% (68/73) in anti-PT IgG, 97.26% (72/73) in anti-FHA IgG, and 100% in anti-PRN IgG were higher than a 100% increase after vaccination. Additionally, the values of 89.04% (65/73) in anti-PT IgG, 97.26% (72/73) in anti-FHA IgG, and 100% in anti-PRN IgG were below each cut-off point. CONCLUSION: We established an in-house ELISA method using self-developed antigens, and these immunoassays have provided a way to standardize measuring the immunogenicity of newly developed vaccines, through single- and dual-serology.
Subject(s)
Diphtheria , Enzyme-Linked Immunosorbent Assay , Hemagglutinins , Immunoassay , Immunoglobulin G , Korea , Methods , Pertussis Toxin , Pertussis Vaccine , Vaccination , Vaccines , Whooping Cough , World Health OrganizationABSTRACT
Objective To investigate the effects of different concentrations and adsorption methods of aluminum hydroxide adjuvant produced by different manufacturers on the immunogenicity of the diphtheria-tetanus-acellular pertussis and inactivated poliovirus combined vaccine ( DTaP-sIPV) . Methods Five anti-gens of DTaP were adsorbed onto different concentrations (0. 42 mg/ml, 0. 47 mg/ml and 0. 52 mg/ml) of aluminum hydroxide from different manufacturers through sequential and separate adsorption. Adsorbability, anti-pertussis toxin ( PT)/filamentous hemagglutinin ( FHA)/pertactin ( PRN)/diphtheria toxoid ( DT)/tet-anus toxoid ( TT) antibodies and the potency of vaccines were detected. Results The adsorbability of alu-minum hydroxide adjuvant slightly decreased with the reduction of concentration. No significant difference in potency and antibody level was observed between sequential and separate adsorption. Moreover, no signifi-cant difference in antibody level was observed between vaccines prepared with aluminum hydroxide adjuvant produced by General Chemical Corp and our institute. Conclusion Aluminum hydroxide adjuvant produced by our institute at the concentration of 0. 52 mg/ml and separate adsorption method are suitable for prepara-tion of DTaP-sIPV.
ABSTRACT
Objective:To study the effects of fluor-hydroxyapatite (FHA) coating titanium alloy on the osseointegration and peri-implantitis of orthodontic micro-implant.Methods:Titanium of FHA alloy (FHA group) and titanium alloy(control group) orthodontic micro-implants were respectively planted into buccal alveolar bone in mandibular premolar area of rabbits.Scanning electron microscope was used to observe the osseointegration around the micro-implants.ELISA was employed to detect TNF-α in the gingival crevicular fluid around the implants.Results:The FHA-coating titanium alloy orthodontic micro-implants led to higher bone density,smaller marrow cavity,and lower TNF-α level and shorter lasting period of TNF-α over-expression than the controls (P ＜ 0.05).Conclusion:The FHA-coating titanium alloy orthodontic micro-implant has better histocompatibility and may inhibit peri-implantitis.
ABSTRACT
Objective:The study aimed at investigating the impact factors of FHA.Methods:The 33-pair subjects were both implemented laboratory check about ?-EP,ACTH,FSH,LH ,E2 in blood and questionnaire about Life Event Scale,EPQ and Coping Style.Results: As for the results of the single factor logistic,the impact factors were very complex.Perhaps the mechanism of FHA resulted from multi-factor interact.The main factors determining whether women suffered from FHA or not were life event,?-EP and withdrawing coping style.Conclusion:The psycholosocial factors of life events,personality and coping styles play important roles in the onset of FHA.