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

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

by Stanley A. Plotkin

ISBN-10: 3805567340

ISBN-13: 9783805567343

Pub. Date: 11/01/1998

Publisher: Karger, S. Inc.

Product Details

Karger, S. Inc.
Publication date:
Developments in Biological Standardization Ser.

Table of Contents

David Magrath Memorial Lecture1
Lessons Learned from the Development of Poliovaccines3
Vaccines, Human Experimentation, and Ethics in Evolutionary Perspective13
Overview of Current Preclinical Testing Strategies for Viral Vaccines19
Review of Current Preclinical Testing Strategies for Bacterial Vaccines25
A Respiratory Challenge Model for Infection with Bordetella pertussis: Application in the Assessment of Pertussis Vaccine Potency and in Defining the Mechanism of Protective Immunity31
DNA Vaccines43
A Phased Approach to Clinical Testing: Criteria for Progressing from Phase I to Phase II to Phase III Studies57
Natural History and Pathogenesis as they Affect Clinical Trials61
Regulatory Aspects of Clinical Trials with Vaccines69
Epidemiological Factors in Clinical Trial Design75
Clinical Evaluation of New Pneumococcal Vaccines: the Finnish Approach85
Assessment of Human CD4+ and CD8+ T Lymphocyte Responses in Experimental Viral Vaccine Studies95
B Cell Responses and Immune Memory105
Immunological Issues in Vaccine Trials: T-Cell Responses117
Immunisation and the Maturation of Infant Immune Responses125
Maternal Immunity and Infant Responses to Immunization: Factors Influencing Infant Responses133
Mucosal Responses to Parenteral and Mucosal Vaccines141
HIV-1 DNA Based Vaccine Induces a CD8 Mediated Cross-Clade CTL Response147
Standardization of Acellular Pertussis Vaccine by Assay of Serum Neutralizing Antibodies to Pertussis Toxin (Antitoxin): Analogy with Diphtheria Toxoid155
Standardization May Suffice for Licensure of Conjugate Vaccines161
Experimental Challenge Studies in the Development of Vaccines for Infectious Diseases169
Immunogenicity Assays and Surrogate Markers to Predict Vaccine Efficacy175
Bridging Studies181
Long-Term Efficacy of Pertussis Vaccines in Italy189
Measuring Protection: Efficacy Versus Effectiveness195
Monitoring and Safety Assessment in Phase I to III Clinical Trials203
Measuring Protection; a Case Study of Pertussis Vaccines - Swedish Trial II: Secondary Non-Randomized Comparisons Between two Schedules of Infant Vaccination211
Measurement of Human Serum IgG Antibodies or a Surrogate is Sufficient to Standardize (Predict Efficacy) Vaccines221
Mathematical Modelling of Effectiveness225
Safety Assessment Post-Licensure235
Clinical Safety Evaluation of Combination Vaccines245
Development and Efficacy Assessment of Combination Vaccines, with Emphasis on Acellular Pertussis251
From Immunisation Research to Policy and Implementation257
Summary and Conclusions261

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