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Book Statistics in Clinical Vaccine Trials

Download or read book Statistics in Clinical Vaccine Trials written by Jozef Nauta and published by Springer Science & Business Media. This book was released on 2010-10-07 with total page 165 pages. Available in PDF, EPUB and Kindle. Book excerpt: This monograph offers well-founded training and expertise on the statistical analysis of data from clinical vaccine trials, i.e., immunogenicity and vaccine field efficacy studies. The book's scope is practical rather than theoretical. It opens with two introductory chapters on the immunology of vaccines to provide readers with the necessary background knowledge. It then continues with an in-depth exploration of the statistical methodology. Many real-life examples and SAS codes are presented, making application of the methods straightforward. Topics discussed include maximum likelihood estimation for censored antibody titers, ANCOVA for antibody values, analysis of equivalence and non-inferiority immunogenicity trial data, analysis of data from vaccine field efficacy trials (including data from studies with recurrent infection data), fitting protection curves to data of challenge or field efficacy studies, and the analysis of vaccine safety data.

Book Vaccine Safety Forum

    Book Details:
  • Author : Institute of Medicine
  • Publisher : National Academies Press
  • Release : 1997-08-10
  • ISBN : 0309057914
  • Pages : 71 pages

Download or read book Vaccine Safety Forum written by Institute of Medicine and published by National Academies Press. This book was released on 1997-08-10 with total page 71 pages. Available in PDF, EPUB and Kindle. Book excerpt: On November 6, 1995, the Institute of Medicine's Vaccine Safety Forum convened a workshop on detecting and responding to adverse events following vaccination. Workshop speakers and participants discussed the difficulties in detecting adverse events, current adverse events detection and response methods and procedures, suggestions for improving the means of detecting and responding to adverse events following vaccination, and future areas of research. This document represents a summary of that workshop.

Book Adverse Effects of Vaccines

    Book Details:
  • Author : Institute of Medicine
  • Publisher : National Academies Press
  • Release : 2012-04-26
  • ISBN : 0309214351
  • Pages : 894 pages

Download or read book Adverse Effects of Vaccines written by Institute of Medicine and published by National Academies Press. This book was released on 2012-04-26 with total page 894 pages. Available in PDF, EPUB and Kindle. Book excerpt: In 1900, for every 1,000 babies born in the United States, 100 would die before their first birthday, often due to infectious diseases. Today, vaccines exist for many viral and bacterial diseases. The National Childhood Vaccine Injury Act, passed in 1986, was intended to bolster vaccine research and development through the federal coordination of vaccine initiatives and to provide relief to vaccine manufacturers facing financial burdens. The legislation also intended to address concerns about the safety of vaccines by instituting a compensation program, setting up a passive surveillance system for vaccine adverse events, and by providing information to consumers. A key component of the legislation required the U.S. Department of Health and Human Services to collaborate with the Institute of Medicine to assess concerns about the safety of vaccines and potential adverse events, especially in children. Adverse Effects of Vaccines reviews the epidemiological, clinical, and biological evidence regarding adverse health events associated with specific vaccines covered by the National Vaccine Injury Compensation Program (VICP), including the varicella zoster vaccine, influenza vaccines, the hepatitis B vaccine, and the human papillomavirus vaccine, among others. For each possible adverse event, the report reviews peer-reviewed primary studies, summarizes their findings, and evaluates the epidemiological, clinical, and biological evidence. It finds that while no vaccine is 100 percent safe, very few adverse events are shown to be caused by vaccines. In addition, the evidence shows that vaccines do not cause several conditions. For example, the MMR vaccine is not associated with autism or childhood diabetes. Also, the DTaP vaccine is not associated with diabetes and the influenza vaccine given as a shot does not exacerbate asthma. Adverse Effects of Vaccines will be of special interest to the National Vaccine Program Office, the VICP, the Centers for Disease Control and Prevention, vaccine safety researchers and manufacturers, parents, caregivers, and health professionals in the private and public sectors.

Book Statistics in Clinical and Observational Vaccine Studies

Download or read book Statistics in Clinical and Observational Vaccine Studies written by Jozef Nauta and published by Springer Nature. This book was released on 2020-03-14 with total page 234 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book offers an overview of the statistical methods used in clinical and observational vaccine studies. Pursuing a practical rather than theoretical approach, it presents a range of real-world examples with SAS codes, making the application of the methods straightforward. This revised edition has been significantly expanded to reflect the current interest in this area. It opens with two introductory chapters on the immunology of vaccines to provide readers with the necessary background knowledge. It then continues with an in-depth exploration of the analysis of immunogenicity data. Discussed are, amongst others, maximum likelihood estimation for censored antibody titers, ANCOVA for antibody values, analysis of data of equivalence, and non-inferiority immunogenicity studies. Other topics covered include fitting protection curves to data from vaccine efficacy studies, and the analysis of vaccine safety data. In addition, the book features four new chapters on vaccine field studies: an introductory one, one on randomized vaccine efficacy studies, one on observational vaccine effectiveness studies, and one on the meta-analysis of vaccine efficacy studies. The book offers useful insights for statisticians and epidemiologists working in the pharmaceutical industry or at vaccines institutes, as well as graduate students interested in pharmaceutical statistics.

Book The Vaccine Book

    Book Details:
  • Author : Barry R. Bloom
  • Publisher : Academic Press
  • Release : 2016-06-23
  • ISBN : 012805400X
  • Pages : 666 pages

Download or read book The Vaccine Book written by Barry R. Bloom and published by Academic Press. This book was released on 2016-06-23 with total page 666 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Vaccine Book, Second Edition provides comprehensive information on the current and future state of vaccines. It reveals the scientific opportunities and potential impact of vaccines, including economic and ethical challenges, problems encountered when producing vaccines, how clinical vaccine trials are designed, and how to introduce vaccines into widespread use. Although vaccines are now available for many diseases, there are still challenges ahead for major diseases, such as AIDS, tuberculosis, and malaria. This book is designed for students, researchers, public health officials, and all others interested in increasing their understanding of vaccines. It answers common questions regarding the use of vaccines in the context of a rapidly expanding anti-vaccine environment. This new edition is completely updated and revised with new and unique topics, including new vaccines, problems of declining immunization rates, trust in vaccines, the vaccine hesitancy, and the social value of vaccines for the community vs. the individual child's risk. - Provides insights into diseases that could be prevented, along with the challenges facing research scientists in the world of vaccines - Gives new ideas about future vaccines and concepts - Introduces new vaccines and concepts - Gives ideas about challenges facing public and private industrial investors in the vaccine area - Discusses the problem of declining immunization rates and vaccine hesitancy

Book The Science and Applications of Synthetic and Systems Biology

Download or read book The Science and Applications of Synthetic and Systems Biology written by Institute of Medicine and published by National Academies Press. This book was released on 2011-12-30 with total page 570 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many potential applications of synthetic and systems biology are relevant to the challenges associated with the detection, surveillance, and responses to emerging and re-emerging infectious diseases. On March 14 and 15, 2011, the Institute of Medicine's (IOM's) Forum on Microbial Threats convened a public workshop in Washington, DC, to explore the current state of the science of synthetic biology, including its dependency on systems biology; discussed the different approaches that scientists are taking to engineer, or reengineer, biological systems; and discussed how the tools and approaches of synthetic and systems biology were being applied to mitigate the risks associated with emerging infectious diseases. The Science and Applications of Synthetic and Systems Biology is organized into sections as a topic-by-topic distillation of the presentations and discussions that took place at the workshop. Its purpose is to present information from relevant experience, to delineate a range of pivotal issues and their respective challenges, and to offer differing perspectives on the topic as discussed and described by the workshop participants. This report also includes a collection of individually authored papers and commentary.

Book Mucosal Vaccines

    Book Details:
  • Author : Hiroshi Kiyono
  • Publisher : Elsevier
  • Release : 1996-10-23
  • ISBN : 0080537057
  • Pages : 501 pages

Download or read book Mucosal Vaccines written by Hiroshi Kiyono and published by Elsevier. This book was released on 1996-10-23 with total page 501 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive, authoritative treatise covers all aspects of mucosal vaccines including their development, mechanisms of action, molecular/cellular aspects, and practical applications. The contributing authors and editors of this one-of-a-kind book are very well known in their respective fields. Mucosal Vaccines is organized in a unique format in which basic, clinical, and practical aspects of the mucosal immune system for vaccine development are described and discussed. This project is endorsed by the Society for Mucosal Immunology. - Provides the latest views on mucosal vaccines - Applies basic principles to the development of new vaccines - Links basic, clinical, and practical aspects of mucosal vaccines to different infectious diseases - Unique and user-friendly organization

Book Vaccinology and Methods in Vaccine Research

Download or read book Vaccinology and Methods in Vaccine Research written by Rebecca Ashfield and published by Elsevier. This book was released on 2022-03-16 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: Vaccinology and Methods in Vaccine Research is a combination of cutting-edge methodologies, experimental approaches and literature reviews. The book covers all aspects of vaccine development, including basic immunology (focusing on the stimulation of adaptive immunity, which is required for vaccine efficacy), approaches to vaccine design and target validation, vaccine biomanufacturer and clinical development. Existing vaccinology resources are theoretical reference books, whereas this book provides a practical handbook for use in the research lab and classroom by those working in vaccinology and training others in the field. It is authored and edited by scientists actively engaged in vaccine research and development for day-to-day teaching/methodological advice. Addresses how to design a vaccine for an emerging disease, from a practical point-of -view, with chapters written by scientists who are grappling with these questions Provides new approaches to vaccine development. including vaccine targeting and virus-like-particle vaccines Gives up-to-date information and methodologies in use for vaccine adjuvants

Book Vaccines

    Book Details:
  • Author : Stanley A. Plotkin
  • Publisher : Elsevier Health Sciences
  • Release : 2008-02-11
  • ISBN : 1437721583
  • Pages : 1748 pages

Download or read book Vaccines written by Stanley A. Plotkin and published by Elsevier Health Sciences. This book was released on 2008-02-11 with total page 1748 pages. Available in PDF, EPUB and Kindle. Book excerpt: Completely revised and updated, this respected reference offers comprehensive and current coverage of every aspect of vaccination-from development to use in reducing disease. It provides authoritative information on vaccine production, available preparations, efficacy, and safety...recommendations for vaccine use, with rationales...data on the impact of vaccination programs on morbidity and mortality...and more. And now, as an Expert Consult title, it includes a companion web site offering this unparalleled guidance where and when you need it most! Provides a complete understanding of each disease, including clinical characteristics, microbiology, pathogenesis, diagnosis, and treatment, as well an epidemiology and public health issues. Offers comprehensive coverage of both existing vaccines and vaccines currently in the research and development stage. Examines vaccine stability, immunogenicity, efficacy, duration of immunity, adverse events, indications, contraindications, precautions, administration with other vaccines, and disease control strategies. Analyses the cost-benefit and cost-effectiveness of vaccines. Discusses the proper use of immune globulins and antitoxins. Illustrates concepts and objective data with approximately 600 tables and figures. Includes access to a companion web site offering the complete contents of the book - fully searchable - for rapid consultation from anyplace with an Internet connection.

Book Vaccines and Autoimmunity

    Book Details:
  • Author : Yehuda Shoenfeld
  • Publisher : John Wiley & Sons
  • Release : 2015-07-07
  • ISBN : 1118663438
  • Pages : 394 pages

Download or read book Vaccines and Autoimmunity written by Yehuda Shoenfeld and published by John Wiley & Sons. This book was released on 2015-07-07 with total page 394 pages. Available in PDF, EPUB and Kindle. Book excerpt: In light of the discovery of Autoimmune Syndrome Induced by Adjuvants, or ASIA, Vaccines and Autoimmunity explores the role of adjuvants – specifically aluminum in different vaccines – and how they can induce diverse autoimmune clinical manifestations in genetically prone individuals. Vaccines and Autoimmunity is divided into three sections; the first contextualizes the role of adjuvants in the framework of autoimmunity, covering the mechanism of action of adjuvants, experimental models of adjuvant induced autoimmune diseases, infections as adjuvants, the Gulf War Syndrome, sick-building syndrome (SBS), safe vaccines, toll-like receptors, TLRS in vaccines, pesticides as adjuvants, oil as adjuvant, mercury, aluminum and autoimmunity. The following section reviews literature on vaccines that have induced autoimmune conditions such as MMR and HBV, among others. The final section covers diseases in which vaccines were known to be the solicitor – for instance, systemic lupus erythematosus – and whether it can be induced by vaccines for MMR, HBV, HCV, and others. Edited by leaders in the field, Vaccines and Autoimmunity is an invaluable resource for advanced students and researchers working in pathogenic and epidemiological studies.

Book Vaccinology

    Book Details:
  • Author : W. John W. Morrow
  • Publisher : John Wiley & Sons
  • Release : 2012-06-12
  • ISBN : 1118345347
  • Pages : 552 pages

Download or read book Vaccinology written by W. John W. Morrow and published by John Wiley & Sons. This book was released on 2012-06-12 with total page 552 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covering all aspects of vaccine research and development in one volume, this authoritative resource takes a comprehensive and systematic approach to the science of vaccinology focusing not only on basic science, but also on the many stages required to commercialize and navigate the regulatory requirements for human application, both in the United States and Europe. Reviews in detail the process of designing a vaccine, from the initial stages of antigen discovery to human application Includes evaluation of vaccine efficacy and safety Details clinical trial design, including regulatory requirements Discusses the emerging field of active cellular immunotherapy Vaccinology: Principles and Practice provides an invaluable resource for clinicians, scientific and medical researchers, lecturers and postdoctoral fellows working in the field of vaccines.

Book Lumpy Skin Disease

    Book Details:
  • Author : Eeva S. M. Tuppurainen
  • Publisher : Springer
  • Release : 2018-07-03
  • ISBN : 3319924117
  • Pages : 99 pages

Download or read book Lumpy Skin Disease written by Eeva S. M. Tuppurainen and published by Springer. This book was released on 2018-07-03 with total page 99 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a comprehensive but concise overview on the economically important emerging cattle pox virus derived Lumpy Skin Disease, including the characteristics of causative agent, description of clinical signs in cattle, pathology and histopathology, immunity, geographical distribution, epidemiology and transmission pathways, control and eradication of the disease. In addition the recent developments in vaccination, mathematical modeling and risk assessment are discussed. Lumpy Skin Disease currently spreads aggressively across the Middle and Near East. The first incursion to the European Union territory occurred in Greece in autumn 2015. The book targets clinicians and field veterinarians in Lumpy Skin Disease affected regions, veterinary authorities as well as advanced students in veterinary medicine and virology.

Book Acute Rheumatic Fever and Rheumatic Heart Disease

Download or read book Acute Rheumatic Fever and Rheumatic Heart Disease written by Dr. Scott Dougherty and published by Elsevier Health Sciences. This book was released on 2020-02-22 with total page 364 pages. Available in PDF, EPUB and Kindle. Book excerpt: Acute Rheumatic Fever and Rheumatic Heart Disease is a concise, yet comprehensive, clinical resource highlighting must-know information on rheumatic heart disease and acute rheumatic fever from a global perspective. Covering the major issues dominating the field, this practical resource presents sufficient detail for a deep and thorough understanding of the latest treatment options, potential complications, and disease management strategies to improve patient outcomes. - Divided into four distinct sections for ease of navigation: Acute Rheumatic Fever, Rheumatic Heart Disease, Population-Based Strategies for Disease Control, and Acute and Emergency Presentations. - International editors and chapter authors ensure a truly global perspective. - Covers all clinical aspects, including epidemiology, pathophysiology, clinical features, diagnosis, management, and treatment. - Includes key topics on population-based measures for disease control for effective primary, secondary, and tertiary prevention. - Consolidates today's available information and guidance into a single, convenient resource.

Book Vaccines

    Book Details:
  • Author : Joseph Domachowske
  • Publisher : Springer Nature
  • Release : 2020-11-01
  • ISBN : 3030584143
  • Pages : 494 pages

Download or read book Vaccines written by Joseph Domachowske and published by Springer Nature. This book was released on 2020-11-01 with total page 494 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is designed to provide easy-to-read and basic information about vaccines for those undertaking a vaccine course or for medical providers seeking to improve their skills. Written by expert medical educators in the areas of infectious diseases, medical microbiology, and pediatrics, this book begins by establishing the fundamentals of vaccines such as what constitutes a vaccine, how they are manufactured and composed, how they are tested for safety and efficacy, and how vaccine recommendations are developed and conveyed to health care providers and their patients. The book then explains the composition, safety profile, effectiveness, and current recommendations for use of every available vaccine, alphabetized by infection. The concluding section illuminates practical concerns every vaccinating clinician experiences, including vaccine confidence and hesitancy, misconceptions, and patient communication. Vaccines: A Clinical Overview and Practical Guide is an excellent learning tool for all students and providers administering vaccines to patients, including infectious disease specialists and other internal medicine subspecialists, pediatricians, geriatricians, as well as all other primary care physicians, nurse practitioners, physician’s assistants, and nurses.

Book The Childhood Immunization Schedule and Safety

Download or read book The Childhood Immunization Schedule and Safety written by Institute of Medicine and published by National Academies Press. This book was released on 2013-04-27 with total page 237 pages. Available in PDF, EPUB and Kindle. Book excerpt: Vaccines are among the most safe and effective public health interventions to prevent serious disease and death. Because of the success of vaccines, most Americans today have no firsthand experience with such devastating illnesses as polio or diphtheria. Health care providers who vaccinate young children follow a schedule prepared by the U.S. Advisory Committee on Immunization Practices. Under the current schedule, children younger than six may receive as many as 24 immunizations by their second birthday. New vaccines undergo rigorous testing prior to receiving FDA approval; however, like all medicines and medical interventions, vaccines carry some risk. Driven largely by concerns about potential side effects, there has been a shift in some parents' attitudes toward the child immunization schedule. The Childhood Immunization Schedule and Safety identifies research approaches, methodologies, and study designs that could address questions about the safety of the current schedule. This report is the most comprehensive examination of the immunization schedule to date. The IOM authoring committee uncovered no evidence of major safety concerns associated with adherence to the childhood immunization schedule. Should signals arise that there may be need for investigation, however, the report offers a framework for conducting safety research using existing or new data collection systems.

Book System Vaccinology

    Book Details:
  • Author : Vijay Kumar Prajapati
  • Publisher : Academic Press
  • Release : 2022-08-20
  • ISBN : 032389786X
  • Pages : 438 pages

Download or read book System Vaccinology written by Vijay Kumar Prajapati and published by Academic Press. This book was released on 2022-08-20 with total page 438 pages. Available in PDF, EPUB and Kindle. Book excerpt: Emergence of new and deadly infectious diseases is significantly deteriorating the human health. Development of vaccine by the scientist has become an important weapon to control the spread of infectious diseases as well as to improve the life expectancy at global level in 20th-21st Century. This book will provide the in-depth knowledge of vaccine history, and development of new strategies to design efficacious and safe vaccine molecule. This book will cover the development of system vaccinology and their applications revolutionize the vaccine discovery. This will provide a resource for the basic and clinical researcher working to human life expectancy by their vaccine experiments and clinical trials. My purpose to write this book to educate the students and researchers with modern development in the field of vaccinology and empowering the researcher with new tools and methodology for developing potential and immunogenic vaccines. This book will be helpful to solve the curiosity of science and medical background students related with vaccinology and will be helpful to devise a new vaccine molecule to control the spread of new and emerging pathogens. Systems biology is a rapidly expanding research discipline aiming to integrate multifaceted datasets generated using state-of-the-art high- throughput technologies such as arrays and next-generation sequencing. Combined with sophisticated computational analysis we are able to interrogate host responses to infections and vaccination on a systems level, thus generating important new hypotheses and discovering unknown associations between immunological parameters. - Provides in-depth knowledge of vaccine history - Covers the development of system vaccinology and their applications revolutionize the vaccine discovery - Gives insights to the development of new strategies to design efficacious and safe vaccine molecule - Provides a resource for the basic and clinical researcher working to human life expectancy by their vaccine experiments and clinical trials - Highlights the importance of differential miRNA expression, microbiome after vaccination for human health - Serves the need of students and researcher for applying computational tools and quick designing of potential molecule which may be proposed for vaccine trial - Take the decisions to perform the kind of experiments for assessment of vaccine immunogenicity - Aims to understand disease pathogenesis and host responses to infection and vaccination - Offers a seamless continuum of scientific discovery and vaccine invention

Book Immunology Made Ridiculously Simple

Download or read book Immunology Made Ridiculously Simple written by Massoud Mahmoudi and published by . This book was released on 2009 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: A brief overview of the basic science and clinical aspects of immunology. The basic science section is a clear presentation of innate and adaptive immunity, immune cells, antibodies and antigens, and other components of the immune system and their interactions. The clinical section clarifies hypersensitivity, autoimmunity, immunodeficiency, common diagnostic tests, vaccination, transplantation, and tumor immunology.