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Conference papers and proceedings
|Additional Physical Format:||Online version:
Preclinical and clinical development of new vaccines.
Basel ; New York : Karger, ©1998
|Material Type:||Conference publication|
|All Authors / Contributors:||
Stanley A Plotkin; Fred Brown; Florian Horaud; Institut Pasteur (Paris, France); International Association of Biological Standardization.
|Notes:||Proceedings of a Symposium organized and sponsored by the Institut Pasteur and the International Association of Biological Standardization (IABS).|
|Description:||xi, 280 pages : illustrations ; 24 cm.|
|Contents:||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).|
|Series Title:||Developments in biological standardization, vol. 95.|
|Responsibility:||volume editors, Stanley A. Plotkin, Fred Brown, Florian Horaud.|
- Vaccines -- Testing -- Congresses.
- Clinical Trials as Topic.
- Drug Approval.
- Vaccin -- congrès.
- Vaccins -- immunologie -- Congrès comme sujet.
- Vaccines -- Testing.
- Vaccins -- Congrès.
- Impfstoff -- Klinische Prüfung -- Kongress -- Paris <1997>.
- Klinische Prüfung -- Impfstoff -- Kongress -- Paris <1997>.