Developments in Biological Standardization. Siehe auch: Progress... / Preclinical and Clinical Development of New Vaccines
Symposium, Institut Pasteur, Paris, May 27-28, 1997.
Published in 1998
Book
Hardback
XII, 284 pages
978-3-8055-6734-3 (ISBN)
Description
This publication covers all aspects of new vaccine development from the preclinical stage to licensing. It contains discussions about the preclinical testing which is necessary to obtain permission to test a new vaccine in clinical trials and to organize a clinical plan that will demonstrate the safety and efficacy of a new vaccine. In addition, some aspects of newer strategies, such as DNA immunization, are presented as well as a number of theoretical issues relating to vaccination, such as immunological correlates of protection, interference with immune responses, combination of vaccines, and the natural history of disease. Much attention is devoted to the proof of efficacy, a process which is both expensive and complicated. This volume is important reading for all scientists interested in vaccine development, especially those working in industry, government and public health authorities.
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Content
Opening session David Magrath Memorial Lecture; lessons learned from the development of poliovaccines, A.J. Beale. Session 1 Preclinical testing prerequisite to phase 1: vaccines, human experimentation, and ethics in evolutionary perspective, M.R. Hilleman; overview of current preclinical testing strategies for viral vaccines, D.J. Wood; review of current preclinical testing strategies for bacterial vaccines, L.A. Falk et al; 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, K.H.G. Mills et al; DNA vaccines, J.J. Donnelly et al. Session 2 General considerations and objectives of clinical trials: a phased approach to clinical testing - criteria for progressing froom phase 1 to phase II to phase III studies, F.E Andre and M.A. Foulkes; natural history and pathogenesis as they affect clinical trials, E.R. Moxon; regulatory aspects of clinical trials with vaccines, A.M. Georges; epidemiological factors in clinical trial design, S. wassilak; clinical evaluation of pneumococcal vaccines - the Finnish approach, J. Eskola et al. Session 3 Immunological issues in vaccine trials: assessment of human CD4+ and CD8+ T lymphocyte responses in experimental viral vaccine studies, A.L. Rothman et al; B cell responses and immune memory, M.K. Slifka and R. Ahmed; immunological issues in vaccine trials - T-cell responses, P. Kourilsky et al; immunization and the maturation of infant immune responses, D. Goldblatt; maternal immunity and infant responses to immunization - factors influencing infant responses, C.A. Siegrist and P.H. Lambert; mucosal responses to parenteral and mucosal vaccines, D. Kaul and P.L. Ogra; HIV-1 DNA based vaccine induces a CD8 mediated cross-clade CTL response, J.D. Boyer et al; standardization of acellular pertussis vaccine by assay of serum neutralizing antibodies to pertussis toxin (antitoxin) - analogy with diptheria toxoid, J.B. Robbins et al. Session 4 Measurement of protection: standardization may suffice for licensure of conjugate vaccines, J.B. Robbins et al; experimental challenge studies in the development of vaccines for infectious diseases, M.M. Levine; immunogenicity assays and surrogate markers to predict vaccine efficacy, H. Kayhty; bridging studies, B. Fritzell; long-term efficacy of pertussis vaccines in Italy, S. Salmaso et al; measuring protection - efficacy versus effectiveness, D. S. Fedson; monitoring and safety assessment in phase I to III clinical trials, R. Fescharek et al; measuring protection - a case study of pertussis vaccines - Swedish trial II; secondary non-randomized comparisons between two schedules of infant vaccination, P. Olin et al; Contents (part).