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Preclinical and Clinical Development of New Vaccines: Symposium, Institut Pasteur, Paris, May, 1997 / Edition 1

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Table of Contents

David Magrath Memorial Lecture 1
Lessons Learned from the Development of Poliovaccines 3
Vaccines, Human Experimentation, and Ethics in Evolutionary Perspective 13
Overview of Current Preclinical Testing Strategies for Viral Vaccines 19
Review of Current Preclinical Testing Strategies for Bacterial Vaccines 25
A Respiratory Challenge Model for Infection with Bordetella pertussis: Application in the Assessment of Pertussis Vaccine Potency and in Defining the Mechanism of Protective Immunity 31
DNA Vaccines 43
A Phased Approach to Clinical Testing: Criteria for Progressing from Phase I to Phase II to Phase III Studies 57
Natural History and Pathogenesis as they Affect Clinical Trials 61
Regulatory Aspects of Clinical Trials with Vaccines 69
Epidemiological Factors in Clinical Trial Design 75
Clinical Evaluation of New Pneumococcal Vaccines: the Finnish Approach 85
Assessment of Human CD4+ and CD8+ T Lymphocyte Responses in Experimental Viral Vaccine Studies 95
B Cell Responses and Immune Memory 105
Immunological Issues in Vaccine Trials: T-Cell Responses 117
Immunisation and the Maturation of Infant Immune Responses 125
Maternal Immunity and Infant Responses to Immunization: Factors Influencing Infant Responses 133
Mucosal Responses to Parenteral and Mucosal Vaccines 141
HIV-1 DNA Based Vaccine Induces a CD8 Mediated Cross-Clade CTL Response 147
Standardization of Acellular Pertussis Vaccine by Assay of Serum Neutralizing Antibodies to Pertussis Toxin (Antitoxin): Analogy with Diphtheria Toxoid 155
Standardization May Suffice for Licensure of Conjugate Vaccines 161
Experimental Challenge Studies in the Development of Vaccines for Infectious Diseases 169
Immunogenicity Assays and Surrogate Markers to Predict Vaccine Efficacy 175
Bridging Studies 181
Long-Term Efficacy of Pertussis Vaccines in Italy 189
Measuring Protection: Efficacy Versus Effectiveness 195
Monitoring and Safety Assessment in Phase I to III Clinical Trials 203
Measuring Protection; a Case Study of Pertussis Vaccines - Swedish Trial II: Secondary Non-Randomized Comparisons Between two Schedules of Infant Vaccination 211
Measurement of Human Serum IgG Antibodies or a Surrogate is Sufficient to Standardize (Predict Efficacy) Vaccines 221
Mathematical Modelling of Effectiveness 225
Safety Assessment Post-Licensure 235
Clinical Safety Evaluation of Combination Vaccines 245
Development and Efficacy Assessment of Combination Vaccines, with Emphasis on Acellular Pertussis 251
From Immunisation Research to Policy and Implementation 257
Summary and Conclusions 261
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