The most urgently needed vaccines are those against poverty-related diseases such as tuberculosis, malaria and HIV. However, there is a considerable gap between the development of a vaccine and the implementation as a useful measure for disease control. Major obstacles need to be overcome even after successful completion of the preclinical stage.
This book provides an important link between vaccine development and application under the particular conditions in developing countries.
The editors, S.H.E. Kaufmann and P.H. Lambert – one from the field of basic research and the other an expert on the side of applied vaccinology – have gathered contributions from specialists of both fields in an attempt to create a source of information that has thus far not been available.
Tabella dei contenuti
Background.- Economic aspects of vaccines and vaccination: a global perspective.- Private hand.- How and why vaccines are made.- How can the industrial world help to implement new vaccines against poverty-related diseases?.- Public-private partnerships.- New approaches towards development, production and use of developing-country market vaccines in developing countries.- Bench.- Novel vaccination strategies.- Design and selection of vaccine adjuvants: principles and practice.- Vaccination in the context of immunological immaturity.- Regulatory issues.- Regulatory issues in the development of new vaccines with a special emphasis on safety aspects.- Clinical trials.- Clinical trials in developing countries: ethical issues.- Vaccine safety and adverse events: lessons learnt.- Sequential stages of clinical trials and overview of issues to be considered.- Practical aspects of phase 3 vaccine trials in developing countries.- Vaccination programmes.- Issues to be considered for the introduction of new vaccines into national vaccination programmes.
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