This volume offers insights into human challenge studies, where adult volunteers are deliberately infected with a pathogen of interest. These studies can broaden our knowledge on infections that have a rather low natural infection rate, but still bear a great threat to global health. The authors also present instances, where no suitable animal model is available to help understand human immune responses to a specific pathogen. The recent SARS-CoV-2 pandemic is another example, where studies that are directly conducted in humans, could save valuable time.

Human challenge studies can provide immunogenicity and early efficacy data for vaccine development. However, similar models could be used for studying a wide variety of medical treatments such as monoclonal antibodies, antibiotics, antivirals and bacteriophages. The chapters in this volume cover several pathogens, including viruses, bacteria and parasites, scientific and technical aspects as well as descriptions of regulatory, ethical and manufacturing requirements.

The book serves as a valuable resource for scientists and clinicians working on human pathogens.

Offers contemporary knowledge on human challenge studies and models Provides data on basic science and technical application of human challenge trials Guides through manufacturing, regulation and ethics

Autorentext

Fabio Bagnoli is Senior Scientific Director at GSK.

Research conducted by Fabio led to the development of various vaccine candidates as well as filing of several patents and publications on different human pathogens published in important peer-review journals.

He promoted innovative research and development approaches: i) Reverse Clinical Development; ii) human organotypic models as vaccine surrogate assays; iii) vaccine formulations able to induce different protective mechanisms.

Fabio Bagnoli has served as editor of several publications and as coordinator of industrial-academic efforts.

He holds a PhD in Molecular and Cellular Microbiology from the University of Padova and conducted post-doctoral studies at Stanford University under the guidance of Dr. Stanley Falkow and Dr. Manuel Amieva.

Giuseppe Del Giudice obtained his MD degree and the post-graduated specialization in Infectious Diseases at the University of Milan, and the PhD degree in Immunology at the University of Geneva, Switzerland.

He then spent 12 years in Switzerland studying the immune response to malaria parasites first at the University of Geneva, then at the University of Lausanne. At the two universities he was appointed as Privat Docent in Immunology. At the same time, he also covered the position of medical officer (staff member) of the World Health Organization, Division of Communicable Diseases, WHO Headquarters, Geneva, Switzerland.

In 1996 he became Senior Research Director at the Research Center of Chiron Vaccines, in Siena, Italy, which then became Novartis Vaccines, and then GSK.

During these years he covered positions with increasing responsibilities becoming responsible of Translational Medicine with Novartis Vaccines and then with GSK Vaccines. During these years he was responsible of several projects on research and development of vaccines against various viral and bacterial diseases as well as on vaccine adjuvants, both parenteral and mucosal.

He is author and co-author of more than 300 publications and member of several international societies and scientific institutional national and supranational boards.

He retired from GSK on 1 January 2021. Now he is an independent consultant for various organizations on aspects related to vaccine research and development.

Sanjay Phogat currently serves as the Vice President at GSK, Research & Development, focusing on bacterial, fungal, viral vaccines, and monoclonal antibodies against infectious diseases. With over twenty years of experience, Sanjay is recognized as an infectious disease expert focusing on viral and bacterial pathogens utilizing various technologies, including RNA, glycoconjugates, adjuvants, structure-based designs, and VLPs. He is recognized as a key scientific contributor to monoclonal antibodies targeting HIV, COVID-19, influenza, and other pathogens, and contributed significantly to global health efforts. His educational training as been in the fields of Microbiology, Biotechnology, and Genetics. With over 80 scientific publications to his name, Sanjay's work is highly regarded within the field, often cited in high-impacts journals.

Rino Rappuoli is Scientific Director of the Fondazione Biotecnopolo di Siena, Italy, Honorary Professor, Imperial College, London, and Senior Professor, University of Siena.

He is elected member of US National Academy of Sciences (NAS), the American Institute for Medical and Biological Engineering (AIMBE) the European Molecular Biology Organization, the Royal Society of London, and President, International Union of Microbiological Societies. He has published 801 works in peer-reviewed journals.

He introduced novel scientific concepts like genetic detoxification, cellular microbiology, reverse vaccinology, and pange

Inhalt

A brief history of human challenge studies (1900-2021) emphasising the virology, regulatory and ethical requirements, raison d'etre, ethnography, selection of volunteers and unit design.- Regulatory aspects of human challenge studies.-Controlled Human Infection challenge studies with RSV.- Human challenge studies with coronaviruses old and new.- Experimental urethral infection with Neisseria gonorrhoeae.- Helicobacter pylori.-Controlled human infection with Bordetella pertussis
Human challenge studies for cholera.- The Controlled Human Infection Model for Enterotoxigenic Escherichia coli.- Challenges in developing a controlled human tuberculosis challenge model.- Shigella Controlled Human Infection Models: Current and Future Perspectives.- The background, role and outline approach for development of a Controlled Human Infection Model for Nontyphoidal Salmonella.- Controlled Human Malaria Infection studies in Africa - past, present, and future.- Controlled infection of humans with the hookworm parasite Necator americanus to accelerate vaccine development.