Human Challenge Studies for Vaccine Development

本書提供了對人類挑戰性研究的深入洞察，其中成年志願者被故意感染感興趣的病原體。這些研究可以擴大我們對於自然感染率相對較低但對全球健康仍然具有巨大威脅的感染病的認識。作者還介紹了一些情況，其中沒有合適的動物模型可以幫助我們了解人體對特定病原體的免疫反應。最近的SARS-CoV-2大流行就是另一個例子，直接在人體中進行的研究可以節省寶貴的時間。

人類挑戰性研究可以為疫苗開發提供免疫原性和早期功效數據。然而，類似的模型也可以用於研究各種醫療治療方法，如單克隆抗體、抗生素、抗病毒藥物和噬菌體。本書的章節涵蓋了多種病原體，包括病毒、細菌和寄生蟲，以及科學和技術方面的內容，以及對監管、倫理和製造要求的描述。

本書對於從事人類病原體研究的科學家和臨床醫生來說是一個寶貴的資源。

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 pangenome. He has developed licensed vaccines among which for acellular pertussis, meningococcus C, and meningococcus B.

Dr. Rappuoli is among the world scientific leaders dedicated to the sustainability of global health.

Fabio Bagnoli是GSK的高級科學總監。

Fabio進行的研究導致了多個疫苗候選者的開發，並在重要的同行評審期刊上發表了關於不同人類病原體的專利和論文。

他提倡創新的研究和開發方法：i) 反向臨床開發；ii) 人體器官模型作為疫苗替代試驗；iii) 能夠誘導不同保護機制的疫苗配方。

Fabio Bagnoli曾擔任多個出版物的編輯和工業-學術合作的協調人。

他擁有帕多瓦大學的分子和細胞微生物學博士學位，並在斯坦福大學進行了斯坦利·法爾科和曼努埃爾·阿米耶瓦博士的指導下的博士後研究。

Giuseppe Del Giudice在米蘭大學獲得了醫學博士學位和傳染病後期專業學位，並在瑞士日內瓦大學獲得了免疫學博士學位。

然後，他在瑞士度過了12年的時間，首先在日內瓦大學，然後在洛桑大學研究瘧疾寄生蟲的免疫反應。在這兩所大學，他被任命為免疫學的私人講師。同時，他還擔任世界衛生組織日內瓦總部傳染病部門的醫務官（職員）。

1996年，他成為錫耶納的Chiron Vaccines研究中心的高級研究總監，後來成為Novartis Vaccines，然後是GSK。

在這些年裡，他擔任了越來越多負責任的職位，成為Novartis Vaccines和GSK Vaccines的轉化醫學負責人。在這些年裡，他負責了多個關於研究和開發各種病毒和細菌疾病疫苗以及疫苗佐劑（包括肌肉注射和黏膜）的項目。

他是300多篇出版物的作者和合著者，並且是幾個國際學會和科學機構的成員。

他於2021年1月1日從GSK退休。現在，他是與疫苗研究和開發相關的各個組織的獨立顧問。

Sanjay Phogat目前擔任GSK研究與開發的副總裁，專注於細菌、真菌、病毒疫苗和對抗傳染病的單克隆抗體。憑藉超過二十年的經驗，Sanjay被認為是一位專注於利用RNA、糖蛋白、佐劑、基於結構設計和VLP等多種技術研究病毒和細菌病原體的傳染病專家。他被認為是針對HIV、COVID-19、流感和其他病原體的單克隆抗體的重要科學貢獻者，並對全球健康事業做出了重大貢獻。他的教育背景涉及微生物學、生物技術和遺傳學。Sanjay已發表了80多篇科學論文，他的工作在該領域中受到高度讚譽，經常被引用在高影響力期刊中。

Rino Rappuoli是意大利錫耶納生物技術中心的科學總監，倫敦帝國學院的榮譽教授和錫耶納大學的高級教授。

他是美國國家科學院（NAS）、美國醫學和生物工程學會（AIMBE）、歐洲分子生物學組織、倫敦皇家學會的當選成員，並擔任國際微生物學協會主席。他在同行評審期刊上發表了801篇論文。

他引入了新的科學概念，如基因解毒、細胞微生物學、反向疫苗學和全基因組。他開發了許可的疫苗。