Vaccine Clinical Trials

This open access book helps to understand how to design and plan clinical development of new vaccines.

The book covers prospective clinical trials at all stages of development, with the target being regulatory approval and market placement, whether for profit or non-profit. Two sections are included, the first covering general principles of vaccine clinical trials and the second covering clinical trials on specific types of vaccines. For the second section the focus is on vaccines particularly well known to the editors so that broad principles can be illustrated.

Vaccine Clinical Trials offers an insight for those who are new to vaccine development in industry as well as governmental and non-governmental organisations. It helps them understand how to design and plan clinical development of new vaccines. For those already active in the vaccine trial field it helps them gain a more integrated view of the process and is of value for those moving to work on new vaccine targets. Whilst written with clinical trial physicians and clinical scientists in mind, it has a broader audience including statisticians, data managers, epidemiologists, pharmacists, medical affairs and pharmacovigilance staff and others. The first section is aimed at people who are very new to vaccine trials and the second is of interest to those moving into the particular areas discussed.

This book is open access, which means that you have free and unlimited access Shares the knowledge of highly successful editors bringing first-in-class and best-in-class vaccines to the market Inspires new researchers by exposing the limits of knowledge in a rapidly growing industry Clarifies the features of vaccine clinical development that differ from other biopharmaceutical products

Autorentext

Dr. Stephen Lockhart is Director and Senior Consultant in Hurst Grange Associates Ltd, a UK-based consulting organization. He was Vice President, Clinical Vaccine Research and Development at Pfizer, with responsibilities including staff in Europe, US, Australia and Japan as well global clinical programs for COVID-19, Clostridiodes difficile and other pathogens. He qualified as a physician over 40 years ago and has over 35 years of experience in biopharmaceutical development with several companies. He is a Fellow of the UK Faculty of Pharmaceutical Medicine (FFPM) and Fellow of the UK Academy of Medical Sciences (FMedSci).
Dr. William Gruber is Adjunct Professor, Depts of Pediatrics and Internal Medicine, Medical School, Adjunct Clinical Professor, Dept of Epidemiology,School of Public Health, University of Michigan, Ann Arbor Michigan. He is the Principal of Gruber Vaccine R&D Consulting, LLC.  He was formerly Senior Vice President and Head of Pfizer Vaccine Clinical Research and Development (VCRD). He has over 40 years of academic and industry experience in vaccine research and development.  His Pfizer VCRD group was responsible for global clinical research and development of now licensed pneumococcal, meningococcal, influenza, COVID-19, and respiratory syncytial virus (RSV) vaccines, in addition to many investigational vaccine candidates.  Before joining industry, Dr. Gruber was an Associate Professor in Pediatric Infectious Diseases at Vanderbilt University School of Medicine.  He is a Fellow of the American Academy of Pediatrics (FAAP), Infectious Diseases Society of America (FIDSA), and Fellow of the Pediatric Infectious Diseases Society (FPIDS).
Dr. Kenneth Koury was Vice President and Head of Statistics for Vaccine Clinical Research and Development at Pfizer, with responsibility for all statistical aspects of global clinical vaccine development.  After receiving a PhD in Biostatistics from the University of North Carolina at Chapel Hill, Ken joined Lederle Laboratories. He has over 35 years of experience in drug and vaccine development including senior leadership at Merck and Schering-Plough.  He previously served as Co-Chair of the FDA/Industry/Academia Safety Graphics Working Group, on PhRMA's BDM Technical Group, and as Program Chair and Chair of the ASA Biopharmaceutical Section.
Dr. Alejandra Gurtman is Senior Vice President and Chief Development officer for Vaccine Clinical Research and Development at Pfizer. Dr. Gurtman received her medical degree and internal medicine training at the University of Buenos Aires, School of Medicine, Argentina qualifying over 30 years ago. . She received postdoctoral training as Fellow in Infectious Diseases at Mount Sinai School of Medicine, New York. She served on the faculty of the Mt. Sinai School of Medicine rising to Associate Professor. She joined Pfizer in 2005 and has led the clinical development of many vaccines, notably including the pneumococcal 13 valent pneumococcal vaccine, Respiratory Syncytial Virus vaccine and COVID vaccine. She is a Fellow of the Infectious Diseases Society of America (FIDSA),

Dr. Annaliesa Anderson is the Senior Vice President and Head of Vaccine Research & Development at Pfizer, and has over 30 years of pharmaceutical research experience. She earned her PhD in biological sciences from the University of Warwick, England, and has contributed to the research and development of many vaccines, including for Human Papilloma Virus at Merck, and pneumococcal disease, meningococcal disease, COVID-19, and respiratory syncytial virus at Pfizer. During the COVID-19 pandemic, she helped lead the development of an antiviral therapy for COVID-19, and now leads the strategic development of an extensive vaccine portfolio for diseases including influenza, C. difficile infection, Group B Streptococcus, and many others. She sits on multiple committees including the American Society for Microbiology Service Awards Selection Committee, as well as Advisory Boards for ContraFect, the Florey Institute, and the Universities of Sheffield and Rochester. is the Senior Vice President and Head of Vaccine Research & Development at Pfizer, and has over 30 years of pharmaceutical research experience. She earned her PhD in biological sciences from the University of Warwick, England, and has contributed to the research and development of many vaccines, including for Human Papilloma Virus at Merck, and pneumococcal disease, meningococcal disease, COVID-19, and respiratory syncytial virus at Pfizer. During the COVID-19 pandemic, she helped lead the development of an antiviral therapy for COVID-19, and now leads the strategic development of an extensive vaccine portfolio for diseases including influenza, C. difficile infection, Group B Streptococcus, and many others. She sits on multiple committees including the American Society for Microbiology Service Awards Selection Committee, as well as Advisory Boards for ContraFect, the Florey Institute, and the Universities of Sheffield and Rochester.

Inhalt

From concept to clinical trial: Starting clinical trials with a new vaccine.- Immunogenicity in first-in-human and early vaccine trials.- Assessing vaccine safety in clinical trials.- Vaccine efficacy trials.- Vaccine immunogenicity for regulatory effectiveness and other regulatory requirements.- Clinical trials of maternal immunisation.- Using controlled human infection models for vaccines.- Running vaccine trials in resource-poor environments.- Ethical aspects and oversight of vaccine clinical trials.- Pneumococcal vaccines.- Meningococcal vaccines.- Group B Streptococcus.- Clostridioides difficile.- Influenza.- Respiratory Syncytial Virus (RSV).- Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2).- Disease X.- Tuberculosis.- Helminthic and Protozoal Neglected Tropical Diseases (NTD).- Gastrointestinal bacterial pathogens.- Malaria.- Rotavirus.