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Utilising successful case studies Vaccine Development will provide insight to the issues scientists face when producing a vaccine, the steps involved and will serve as an ideal reference tool regarding state-of-the-art vaccine development.
The past three decades have witnessed the development and regulatory approval of glycoconjugate vaccines against several medically important bacterial pathogens, including Haemophilus influenzae type b, Streptococcus pneumoniae, Neisseria meningitides, and Salmonella typhi. Immunologic protection against these and many other bacterial diseases is mediated through opsonophagocytic antibodies directed against the surface carbohydrates that define the bacterial serogroup or serotype and serve as virulence factors. These vaccines are composed of bacterial capsular polysaccharides chemically conjugated to immunogenic carrier proteins. Given that the diseases caused by these bacterial pathogens are most pronounced in infants and young children, the development of the glycoconjugate vaccine technology has had a considerable impact on public health. Many of the chapters in this volume were assembled as a follow-up from a symposium entitled "Carbohydrate-Based Vaccines and Adjuvants" which took place at the 254th American Chemical Society National Meeting held in Washington, DC (August 2017). The symposium was sponsored by Pfizer and the Carbohydrate (CARB) and Biotechnology (BIOT) divisions. This book, therefore, reflects the importance of this field toward design, development, manufacture and licensure of the complex carbohydrate-based (glycoconjugate) vaccines. The book has been organized into thirteen chapters, which cover a comprehensive landscape including the clinical history, design, development, chemistry, manufacturing and control (CMC) aspects, pre-clinical assays, adjuvants and the various approaches used to develop carbohydrate-based vaccines.
Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.
A legacy of our generation -- Ch. 1. We need to invest more in vaccines -- Ch. 2. Promoting private investment in vaccine development -- Ch. 3. A market not a prize -- Ch. 4. Design choices -- Ch. 5. $3 billion per disease -- Ch. 6. Meeting industry requirements -- Ch. 7. How sponsors can do it.
This remarkable book tells you everything you need to know about vaccines. Having nearly 40 years’ experience of the subject, the author covers the history of vaccines, how they work, how research is carried out, their safety, how they are used in society, the inside track on COVID-19 and what the future holds. It is a deeply personal account, with anecdotes involving a cow called Blossom, a hospital in the Caribbean, a crocodile-infested lake in Malawi, an encounter with Russian soldiers in Prague and many others. An A-to-Z section covers every vaccine from Anthrax to Yellow Fever. It will educate, entertain and enlighten the vaccine scientific community and public health practitioners. Key Features • Explores a highly topical concept of vaccines in a comprehensive and easy-to-read manner • Engages readers with relatable and interesting anecdotes • Provides a balanced, factual counter to the huge amount of current vaccine misinformation
Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
This book is the first of its kind entirely dedicated to carbohydrate vaccines written by renowned scientists with expertise in carbohydrate chemistry and immunochemistry. It covers the synthesis of carbohydrate antigens related to bacteria and parasites such as: Heamophilus influenza, Streptococcus pnemoniae, Shigella flexneri, Candida albicans, Mycobacterium tuberculosis, and Chlamydia. The first three chapters are of wide interest as they cover fundamental concerns in new vaccine developments. The first one presents the immune system and how carbohydrate antigens are processed before protective antibodies are produced. It also illustrates antigen presentation in the context of major histocompatibility complexes (MHCs). The second chapter describes regulatory issues when carbohydrate vaccines are involved while the third one discuss several techniques used in conjugation chemistry and the implication of certain chemical linkages that may induce unexpected anti-linker antibodies. This section will be particularly appealing for those involved in drug-conjugate design, pro-drug developments, and drug vectorization. The book concludes with one chapter that illustrates the principle through which peptide antigens can functionally mimic carbohydrate epitopes, thus, unraveling the potential for peptide surrogates as replacement for complex carbohydrate structures. This book is unique in that it covers all aspects related to carbohydrate vaccines including the success story with the first semi-synthetic bacterial polysaccharide vaccine against Heamophilus influenza type b responsible for pneumonia and meningitis, liable for more than 600,000 infant deaths worldwide in developing countries. The book also presents regulatory issues and will thus be vital for government agencies approving candidate vaccines. It widely covers synthetic methodologies for the attachment of carbohydrate antigens to peptides and immunogenic protein carriers. Vaccines against bacterial antigens, cancer, and parasites are also discussed by worldwide experts in this field in details. No other book contains such a wide panel of different expertise. It will also be useful to students and researchers involved with the immunology of forreings antigens and how the under appreciated carbohydrate antigens are processed by the immune system.
Vaccinology, the concept of a science ranging from the study of immunology to the development and distribution of vaccines, was a word invented by Jonas Salk. This book covers the history of the methodological progress in vaccine development and to the social and ethical issues raised by vaccination. Chapters include "Jenner and the Vaccination against Smallpox," "Viral Vaccines," and "Ethical and Social Aspects of vaccines." Contributing authors include pioneers in the field, such as Samuel L. Katz and Hilary Koprowski. This history of vaccines is relatively short and many of its protagonists are still alive. This book was written by some of the chief actors in the drama whose subject matter is the conquest of epidemic disease.