PrimaryImmunogenicityEndpointsforNewInfantPneumoco：新的婴儿pneumoco主要免疫原性的端点.pptVIP

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2017-08-08 发布于重庆
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PrimaryImmunogenicityEndpointsforNewInfantPneumoco：新的婴儿pneumoco主要免疫原性的端点.ppt

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PrimaryImmunogenicityEndpointsforNewInfantPneumoco：新的婴儿pneumoco主要免疫原性的端点.ppt

Overview Background Prevnar clinical efficacy trial: invasive pneumococcal disease (IPD) VRBPAC 2001 Comparative immunogenicity studies in U.S. children WHO Technical Report Series (TRS) No.927 Pneumococcal IgG antibody concentration: 0.35 μg/mL Opsonophagocytic antibody (OPA): important supportive data Post-marketing effectiveness studies PCV13 pivotal U.S. immunogenicity trial design Immunogenicity assessment to support licensure Overview Background Prevnar clinical efficacy trial: invasive pneumococcal disease (IPD) VRBPAC 2001 Comparative immunogenicity studies in U.S. children WHO Technical Report Series (TRS) No.927 Pneumococcal IgG antibody concentration: 0.35 μg/mL Opsonophagocytic antibody (OPA): important supportive data Post-marketing effectiveness studies PCV13 pivotal U.S. immunogenicity trial design Immunogenicity assessment to support licensure WHO consultation meetings2003-03 WHO TRS No. 927: published in 2005 WHO recommendations to assure the quality, safety and efficacy of pneumococcal conjugate vaccines IgG antibody concentration: 0.35 μg/mL Reference point: Immunogenicity of a candidate pneumococcal conjugate vaccine to a U.S. licensed vaccine. Prevention of vaccine serotype IPD. Not a correlate of protection OPA Assay limitations Important supportive data Post-licensure safety and effectiveness Immunological Bridging of Two ELISA Assay Methods New ELISA assay method (22F pre-adsorption) Increased assay specificity after a 2 step pre-adsorption WHO reference ELISA (no 22F pre-adsorption) 0.35 μg/mL IgG antibody reference value Bridging of two ELISA assay methods Equivalent IgG antibody concentration = 0.32ug/mL 0.35ug/mL retained as the reference value Overview Background Prevnar clinical efficacy trial: IPD VRBPAC 2001 Comparative immunogenicity studies in US children WHO Technical Report Series (TRS) No.927 Pneumococcal IgG antibody concentration: 0.35 μg/mL Opsonophagocytic antibody (OPA): important supportive data Post-marketing ef