Preclinical and clinical development of new vaccines: Institut Pasteur, Paris, France, 27 - 28 May 1997 ; proceedings of a symposium ; 42 tables
Gespeichert in:
| Format: | Buch |
|---|---|
| Sprache: | German |
| Veröffentlicht: |
Basel [u.a.]
Karger
1998
|
| Schriftenreihe: | Developments in biological standardization
95 |
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | Literaturangaben |
| Beschreibung: | XI, 280 S. graph. Darst. |
| ISBN: | 3805567340 |
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Datensatz im Suchindex
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|---|---|
| adam_text | Contents
Opening Session
David Magrath Memorial Lecture 1
Lessons Learned from the Development of Poliovaccines 3
A.J. Beale
Session I
Preclinical Testing Prerequisite to Phase 1 11
Chairpersons: M. Hilleman and G. Schild
Vaccines, Human Experimentation, and Ethics in Evolutionary Perspective 13
M.R. Hilleman
Overview of Current Preclinical Testing Strategies for Viral Vaccines 19
D.J. Wood
Review of Current Preclinical Testing Strategies for Bacterial Vaccines 25
L.A. Folk, D.K.F. Chandler, P. Richman
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
K.H.G. Mills, M. Brady, E. Ryan, B.P. Mahon
DNA Vaccines 43
J.J. Donnelly, J.B. Ulmer, M.A. Liu
Session II
General Considerations and Objectives of Clinical Trials 55
Chairpersons: F. Andre and J. Eskola
A Phased Approach to Clinical Testing: Criteria for Progressing from Phase I to Phase II to
Phase III Studies 57
F.E. Andre, M.A. Foulkes
Natural History and Pathogenesis as they Affect Clinical Trials 61
E.R. Moxon
Regulatory Aspects of Clinical Trials with Vaccines 69
A.M. Georges
Epidemiological Factors in Clinical Trial Design 75
S. Wassilak
Clinical Evaluation of New Pneumococcal Vaccines: the Finnish Approach 85
J. Eskola, A.K. Takala, T.M. Kilpi, K.S. Lankinen, H. Kayhty
IX
Session III
Immunological Issues in Vaccine Trials 93
Chairpersons: F. Ennis and J. Poolman
i
Assessment of Human CD4+ and CD8+ T Lymphocyte Responses in Experimental Viral ;
Vaccine Studies 95 ,
A.L. Rothman, Y. Yamada, J. Jameson, J. Cruz, K. West, S. Green, FA. Ennis
B Cell Responses and Immune Memory 105
M.K. Slifka, R. Ahmed
Immunological Issues in Vaccine Trials: T Cell Responses 117
P. Kourilsky, P. Bousso, S. Calbo, L. Gapin
Immunisation and the Maturation of Infant Immune Responses 125
D. Goldblatt
Maternal Immunity and Infant Responses to Immunization: Factors Influencing Infant
Responses 133
C.A. Siegrist, PH. Lambert
Mucosal Responses to Parenteral and Mucosal Vaccines 141
D. Kaul, PL. Ogra
HIV 1 DNA Based Vaccine Induces a CD8 Mediated Cross Clade CTL Response 147
J.D. Boyer, M. Chattergoon, A. Shah, R. Ginsberg, R.R. MacGregor, D.B. Weiner
Standardization of Acellular Pertussis Vaccine by Assay of Serum Neutralizing Antibodies to
Pertussis Toxin (Antitoxin): Analogy with Diphtheria Toxoid 155
J.B. Robbins, R. Schneerson, B. Trollfors, J. Taranger, T. Lagergard
Session IV
Measurement of Protection 159
Chairpersons: J.B. Robbins and S.A. Plotkin
Standardization May Suffice for Licensure of Conjugate Vaccines 161
J.B. Robbins, R. Schneerson, S.C. Szu, D.A. Bryla, F. Y. Lin, E.C. Gotschlich
Experimental Challenge Studies in the Development of Vaccines for Infectious Diseases 169
M.M. Levine
Immunogenicity Assays and Surrogate Markers to Predict Vaccine Efficacy 175
H. Kayhty
Bridging Studies 181
B. Fritzell
Long Term Efficacy of Pertussis Vaccines in Italy 189
S. Salmaso, A. Anemona, P. Mastrantonio, P. Stefanelli, A.E. Tozzi, M.L. Ciofi degli Atti,
the PROPER Study Working Group
Measuring Protection: Efficacy Versus Effectiveness 195
D.S. Fedson
Monitoring and Safety Assessment in Phase I to III Clinical Trials 203
R. Fescharek, U. Nicolay, C. Arras Reiter
Measuring Protection; a Case Study of Pertussis Vaccines Swedish Trial II: Secondary Non
Randomized Comparisons Between two Schedules of Infant Vaccination 211
P. Olin, H.O. Hollander, L. Gustafsson, L. Barreto, A. Podda
Measurement of Human Serum IgG Antibodies or a Surrogate is Sufficient to Standardize
(Predict Efficacy) Vaccines 221
J.B. Robbins, R. Schneerson, S.C. Szu, D.A. Bryla, F. Y. Lin
X Contents
Session V
Safety and Other Issues 223
Chairperson: D. Salisbury
Mathematical Modelling of Effectiveness 225
A.R. McLean
Safety Assessment Post Licensure 235
E. Miller, P. Waight, P. Farrington
Clinical Safety Evaluation of Combination Vaccines 245
K. Midthun, A.D. Home, K.L. Goldenthal
Development and Efficacy Assessment of Combination Vaccines, with Emphasis on Acellular
Pertussis 251
I P. Hauser, D. De Grave, F. Zepp, J. Poolman, M. Slaoui
From Immunisation Research to Policy and Implementation 257
D.M. Salisbury
Summary and Conclusions 261
I
Contents XI
|
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| dewey-ones | 615 - Pharmacology and therapeutics |
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| dewey-sort | 3615 3372 |
| dewey-tens | 610 - Medicine and health |
| discipline | Medizin |
| format | Book |
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| illustrated | Illustrated |
| indexdate | 2024-07-09T18:26:01Z |
| institution | BVB |
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| isbn | 3805567340 |
| language | German |
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| series2 | Developments in biological standardization |
| spelling | Preclinical and clinical development of new vaccines Institut Pasteur, Paris, France, 27 - 28 May 1997 ; proceedings of a symposium ; 42 tables organized and sponsored by the Institut Pasteur ... Vol. eds.: Stanley A. Plotkin ... Basel [u.a.] Karger 1998 XI, 280 S. graph. Darst. txt rdacontent n rdamedia nc rdacarrier Developments in biological standardization 95 Literaturangaben Impfstoff (DE-588)4026655-2 gnd rswk-swf Arzneimittelentwicklung (DE-588)4143176-5 gnd rswk-swf (DE-588)1071861417 Konferenzschrift 1997 Paris gnd-content Impfstoff (DE-588)4026655-2 s DE-604 Arzneimittelentwicklung (DE-588)4143176-5 s Plotkin, Stanley A. 1932- Sonstige (DE-588)13312780X oth Institut Pasteur (Paris) Sonstige (DE-588)36271-2 oth Developments in biological standardization 95 (DE-604)BV000000884 95 HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=008374188&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Preclinical and clinical development of new vaccines Institut Pasteur, Paris, France, 27 - 28 May 1997 ; proceedings of a symposium ; 42 tables Developments in biological standardization Impfstoff (DE-588)4026655-2 gnd Arzneimittelentwicklung (DE-588)4143176-5 gnd |
| subject_GND | (DE-588)4026655-2 (DE-588)4143176-5 (DE-588)1071861417 |
| title | Preclinical and clinical development of new vaccines Institut Pasteur, Paris, France, 27 - 28 May 1997 ; proceedings of a symposium ; 42 tables |
| title_auth | Preclinical and clinical development of new vaccines Institut Pasteur, Paris, France, 27 - 28 May 1997 ; proceedings of a symposium ; 42 tables |
| title_exact_search | Preclinical and clinical development of new vaccines Institut Pasteur, Paris, France, 27 - 28 May 1997 ; proceedings of a symposium ; 42 tables |
| title_full | Preclinical and clinical development of new vaccines Institut Pasteur, Paris, France, 27 - 28 May 1997 ; proceedings of a symposium ; 42 tables organized and sponsored by the Institut Pasteur ... Vol. eds.: Stanley A. Plotkin ... |
| title_fullStr | Preclinical and clinical development of new vaccines Institut Pasteur, Paris, France, 27 - 28 May 1997 ; proceedings of a symposium ; 42 tables organized and sponsored by the Institut Pasteur ... Vol. eds.: Stanley A. Plotkin ... |
| title_full_unstemmed | Preclinical and clinical development of new vaccines Institut Pasteur, Paris, France, 27 - 28 May 1997 ; proceedings of a symposium ; 42 tables organized and sponsored by the Institut Pasteur ... Vol. eds.: Stanley A. Plotkin ... |
| title_short | Preclinical and clinical development of new vaccines |
| title_sort | preclinical and clinical development of new vaccines institut pasteur paris france 27 28 may 1997 proceedings of a symposium 42 tables |
| title_sub | Institut Pasteur, Paris, France, 27 - 28 May 1997 ; proceedings of a symposium ; 42 tables |
| topic | Impfstoff (DE-588)4026655-2 gnd Arzneimittelentwicklung (DE-588)4143176-5 gnd |
| topic_facet | Impfstoff Arzneimittelentwicklung Konferenzschrift 1997 Paris |
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| volume_link | (DE-604)BV000000884 |
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