Combined vaccines and simultaneous administration current issues and perspectives ; [the conference was held on July 28 - 30, 1993 in Bethesda, Maryland]
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1995
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Datensatz im Suchindex
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| adam_text | ANNALS OF THE NEW YORK ACADEMY OF SCIENCES
Volume 754
May 31, 1995
COMBINED VACCINES AND
SIMULTANEOUS ADMINISTRATION
CURRENT ISSUES AND PERSPECTIVES
Editors
Jim C. Williams, Karen L. Goldenthal, Drusilla L. Burns,
and Benjamin P. Lewis, Jr.
Workshop Co chairs
Drusilla L. Burns and Jim C. Williams
Workshop Program Committee
Drusilla L. Burns, Joy A. Cavagnaro, Elaine C. Esber, Karen L. Goldenthal,
M. Carolyn Hardegree, Benjamin P. Lewis, Jr., and Jim C. Williams
CONTENTS
Overview Combination Vaccines and Simultaneous Administration:
Past, Present, and Future. By Karen L. Goldenthal,
Drusilla L. Burns, Loris D. McVittie, Benjamin P. Lewis, Jr.,
and Jim C. Williams xi
Part I. The Interface between Vaccine Initiatives, New Technologies,
and Vaccine Development
Elaine C. Esber and M. Teresa Aguado, Co chairs
Combined and Simultaneously Administered Vaccines: A Brief History.
By Paul D. Parkman 1
FDA Perspective on Regulatory Issues in Vaccine Development.
By Bascom F. Anthony 10
Strategies for Developing Combination Vaccines. By Ronald J. Saldarini ... 17
Manufacturing Issues for Multivalent Vaccines. By Arthur Y. Elliott 23
Combination Vaccines: Regulatory Issues. By D. K. McClintock 27
This volume is the result of a conference entitled Combined Vaccines and Simultaneous I
Administration: Current Issues and Perspectives, which was sponsored by the Center for Biologies I
Evaluation and Research, United States Food and Drug Administration; the National Vaccine
Program Office; the National Institute of Allergy and Infectious Diseases, the National Institutes
of Health; the Centers for Disease Control and Prevention; and the World Health Organization.
The conference was held on July 28 30, 1993 in Bethesda, Maryland.
Part II. Advances in the Development of Conjugate
and Combination Vaccines
Claire V. Broome and Geoffrey Schild, Co chairs
Potential Alterations in Immunogenicity by Combining or Simultaneously
Administering Vaccine Components. By Richard A. Insel 35
Determinant Flanking Regions and the Design of Appropriate Vaccines.
By Luis Soares, Hongkui Deng, Iqbal S. Grewal, Vipin Kumar,
Alexander Miller, Kamal D. Moudgil, Mark Palmer, and
Eli E. Sercarz 48
Selection of Carrier and B Cell Protectope Sequences for Vaccines.
By Howard M. Etlinger 57
Prevention of Systemic Infections Caused by Group B Streptococcus and
Stttphybcoccus aureus by Multivalent Polysaccharide Protein Conjugate Vaccines.
By John B. Robbins, Rachel Schneerson, Willie F. Vann,
Dolores A. Bryla, and Ali Fattom 68
Definition and Clinical Assessment of Consistency Lots for Combination
Vaccines. By Bernard Fritzell 83
Immune Responses to Pertussis Vaccines Concurrently Administered with
Viral Vaccines. By Scott A. Halperin, Brian J. Eastwood, and
Joanne M. Langley 89
Comparative Evaluation of Immunization with Live Attenuated and
Inactivated Poliovirus Vaccines. By Pearay L. Ogra 97
Combination Vaccines for Diphtheria, Tetanus, Pertussis, and Haemophilus
influenzae Type b. By Peter R. Paradiso 108
Part III. New Approaches in Design and Use of Vaccine Adjuvants
William E. Paul and Joy A. Cavagnaro, Co chairs
The Biochemistry and Cell Biology of Antigen Presentation by MHC Class I
and Class II Molecules: Implications for Development of Combination
Vaccines. By Ronald N. Germain 114
Vaccine Strategies: Targeting Helper T Cell Responses. By Basil Golding
and Dorothy E. Scott 126
The Role of sIgA+ B Cells in Oral Immunity. By Rolf O. Ehrhardt and
Warren Strober 138
Liposomal Vaccines: Clinical Status and Immunological Presentation for
Humoral and Cellular Immunity. By Carl R_ Alving 143
Immunologic Adjuvants for Modern Vaccine Formulations.
By Frederick R. Vogel 153
Designing Peptide Vaccines to Broaden Recognition and Enhance Potency.
By Jay A. Berzofsky 161
Galactose Oxidation as a Potent Vaccine Adjuvant Strategy: Efficacy in
Murine Models and in Protection against a Bovine Parasitic Infection.
By John Rhodes, Biao Zheng, and Christopher A. Morrison 169
Part IV. New Antigen Delivery Systems: Construction and Use
Barry R. Bloom and John R. La Montagne, Co chairs
The Hepatitis Nucleocapsid as a Vaccine Carrier Moiety. By D. R. Milich,
D. L. Peterson, J. Zheng, J. L. Hughes, R. Wirtz, and F. Schodel . . . 187
Yeast Retrotransposon Particles as Antigen Delivery Systems.
By Alan J. Kingsman, Nigel R. Burns, Guy T. Layton, and
Sally E. Adams 202
Progress on Development of the Live BCG Recombinant Vaccine Vehicle for
Combined Vaccine Delivery. By Mark S. Hanson,
Claudia Vigil Lapcevich, and Shirley L. Haun 214
Live Attenuated Vaccinia and Other Poxviruses as Delivery Systems: Public
Health Issues. By Marion E. Perkus, Jill Taylor, James Tartaglia,
Steven Pincus, Elizabeth B. Kauffman, John A. Tine, and
Enzo Paoletti 222
Part V. Considerations for the Evaluation of Combination Vaccines:
Clinical Design, Efficacy, and Statistical Issues
Karen L. Goldenthal and Walter A. Orenstein, Co chairs
Issues in Design of Clinical Trials of Combination Vaccines.
By Michael D. Decker and Kathryn M. Edwards 234
Industry Perspective on Clinical Trial Issues for Combination Vaccines.
By Kenneth R. Brown 241
Practical Considerations Regarding the Impact on Immunization Schedules of
the Introduction of New Combined Vaccines. By Neal A. Halsey 250
Interactions between PRP T Vaccine against Haemophilus inflnenzae Type b and
Conventional Infant Vaccines: Lessons for Future Studies of Simultaneous
Immunization and Combined Vaccines. By John Clemens,
Ruth Brenner, and Malla Rao 255
International Prospects for Combined Vaccines with Emphasis on
Quadrivalent Diphtheria Tetanus Pertussis Hepatitis B Vaccine.
By Joseph L. Melnick 267
Defining Surrogate Serologic Tests with Respect to Predicting Protective
Vaccine Efficacy: Pertussis Vaccination. By Patrick Olin 273
Laboratory Correlates of Protection against Haemophilus influenzae Type b
Disease: Importance of Assessment of Antibody Avidity and Immunologic
Memory. By Dan M. Granoff and Alexander H. Lucas 278
Defining Surrogate Serologic Tests with Respect to Predicting Protective
Vaccine Efficacy: Poliovirus Vaccination. By Roland W. Sutter,
Mark A. Pallansch, Leigh A. Sawyer, Stephen L. Cochi, and
Stephen C. Hadler 289
Methodological Issues in the Evaluation and Monitoring of Vaccine Safety.
By Paul E. M. Fine 300
Surveillance of the Safety of Simultaneous Administration of Vaccines:
The Centers for Disease Control and Prevention Experience.
By Robert T. Chen, Penina Haber, and John R. Mullen 309
Similarity/Equivalence Trials for Combination Vaccines.
By William C. Blackwelder 321
The Statistical Analysis of Immunogenicity Data in Vaccine Trials: A Review
of Methodologies and Issues. By Amelia Dale Horne 329
Part VT. Clinical Considerations for the Evaluation
of Combination Vaccines
Karen L. Goldenthal and Walter A. Orenstein, Co chairs
Combination Live Enteric Virus Vaccines. By Samuel L. Katz 347
Combination Live Respirator) Virus Vaccines. By Mary Lou Clements .... 351
Progress and Challenges for a New Combination Vaccine Composed of
Diphtheria, Tetanus, Acellular Pertussis, and Haemophilus b Conjugate.
By Dace V. Madore 356
Surrogate Serologic Tests for the Prediction of Pertussis Vaccine Efficacy.
By James D. Cherry, Ulrich Heininger, Peter D. Christenson,
Thomas Eckhardt, Suzanne Laussucq, Jill G. Hackell,
Joseph R Mezzatesta, and Klemens Stehr 359
Comprehensive Evaluation of Vaccine Safety: Assessment of Local and
Systemic Side Effects as well as Emergency and Hospital Utilization.
By Steven Black and Henry Shinefield 364
Vaccine Licensure: A Proposal to Meet Changing Needs.
By Frederick C. Robbins and Edward A. Mortimer, Jr 368
Utility of Large linked Databases in Vaccine Safety, Particularly in Distinguishing
Independent and Synergistic Effects. By Steven G. F. Wassilak,
John W. Glasser, Robert T Chen, Stephen C. Hadler, and
the Vaccine Safety Datalink Investigators 377
Combination Vaccines: Some Practical Considerations.
By Robert S. Daum, Anjali Jain, and Karen P. Goldstein 383
Summary
Summary: A Perspective on Issues Relating to Future Vaccines.
By Barry R Bloom 388
Subject Index 397
Index of Contributors 403
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| spellingShingle | Combined vaccines and simultaneous administration current issues and perspectives ; [the conference was held on July 28 - 30, 1993 in Bethesda, Maryland] Annals of the New York Academy of Sciences Kombinationstherapie (DE-588)4194534-7 gnd Impfung (DE-588)4026656-4 gnd Impfstoff (DE-588)4026655-2 gnd |
| subject_GND | (DE-588)4194534-7 (DE-588)4026656-4 (DE-588)4026655-2 (DE-588)1071861417 |
| title | Combined vaccines and simultaneous administration current issues and perspectives ; [the conference was held on July 28 - 30, 1993 in Bethesda, Maryland] |
| title_auth | Combined vaccines and simultaneous administration current issues and perspectives ; [the conference was held on July 28 - 30, 1993 in Bethesda, Maryland] |
| title_exact_search | Combined vaccines and simultaneous administration current issues and perspectives ; [the conference was held on July 28 - 30, 1993 in Bethesda, Maryland] |
| title_full | Combined vaccines and simultaneous administration current issues and perspectives ; [the conference was held on July 28 - 30, 1993 in Bethesda, Maryland] ed. by Jim C. Williams ... |
| title_fullStr | Combined vaccines and simultaneous administration current issues and perspectives ; [the conference was held on July 28 - 30, 1993 in Bethesda, Maryland] ed. by Jim C. Williams ... |
| title_full_unstemmed | Combined vaccines and simultaneous administration current issues and perspectives ; [the conference was held on July 28 - 30, 1993 in Bethesda, Maryland] ed. by Jim C. Williams ... |
| title_short | Combined vaccines and simultaneous administration |
| title_sort | combined vaccines and simultaneous administration current issues and perspectives the conference was held on july 28 30 1993 in bethesda maryland |
| title_sub | current issues and perspectives ; [the conference was held on July 28 - 30, 1993 in Bethesda, Maryland] |
| topic | Kombinationstherapie (DE-588)4194534-7 gnd Impfung (DE-588)4026656-4 gnd Impfstoff (DE-588)4026655-2 gnd |
| topic_facet | Kombinationstherapie Impfung Impfstoff Konferenzschrift 1993 Bethesda Md. Konferenzschrift 1993 Bethesda, Md. |
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