Vaccine development : from concept to clinic /

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.

מידע ביבליוגרפי
מחברים אחרים: Prasad, A. Krishna (Editor)
פורמט: Licensed eBooks
שפה:אנגלית
יצא לאור: Cambridge : Royal Society of Chemstry, 2022.
סדרה:RSC Drug development and pharmaceutical science.
גישה מקוונת:https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=3453660
תוכן הענינים:
  • Cover
  • Dedication
  • Foreword
  • Contents
  • Chapter 1 Vaccine Development: From Concept to Clinic
  • 1.1 Introduction
  • 1.2 Preclinical Safety Assessment Considerations
  • 1.3 Clinical Trials in the Development of Vaccines
  • 1.5 High-throughput Assays for Clinical Development
  • 1.6 Complexity in the Development of Multivalent Vaccines: Virus-like Particle-based Vaccines
  • 1.7 Cell Culture-based Influenza Vaccine Development
  • 1.8 Conjugate Vaccines: Design and Development Considerations
  • 1.9 Vaccine Adjuvants
  • 1.10 Development Considerations for Final Dosage Forms: Mucosal Bacterial Vaccines
  • 1.11 Exploiting Glycans for Vaccine Design
  • 1.12 Public-Private Partnerships for Vaccine Development
  • 1.13 Structure-based Vaccine Design: The New Frontier
  • 1.14 Vaccines to Target Antimicrobial Resistance
  • 1.15 Technologies Revolutionizing Vaccines
  • 1.15.1 Vaccines Based on Nucleic Acids
  • 1.15.2 VLPs Produced from Plants
  • 1.16 Vaccines Targeting Latent Viruses
  • 1.16.1 Vaccines Targeting Shingles
  • 1.16.2 Human Cytomegalovirus (CMV)
  • 1.16.3 Epstein-Barr Virus (EBV)
  • 1.17 The Unmet Medical Need
  • 1.18 Herd Immunity
  • References
  • Chapter 2 Preclinical Safety Assessment Considerations for Vaccine Development
  • Introduction
  • 2.2 General Considerations
  • 2.2.1 Regulatory Guidelines for the Non-clinical Safety Assessment of Vaccines and Adjuvants
  • 2.2.2 Vaccine Modalities
  • 2.2.3 Antigen
  • 2.2.4 Adjuvant
  • 2.3 Vaccine Study Design
  • 2.3.1 Test Article
  • 2.3.2 Species Selection
  • 2.3.3 Study Groups
  • 2.3.4 Dose, Dose Volume, and Administration Location
  • 2.3.5 Dose Number and Dosing Interval
  • 2.3.6 In-life Assessments
  • 2.3.7 Anatomical Pathology
  • 2.4 Genotoxicity and Carcinogenicity Studies
  • 2.5 Biodistribution Studies
  • 2.6 Neurovirulence Studies
  • 2.7 Reproductive Toxicology Studies
  • 2.8 Conclusion
  • References
  • Chapter 3 Clinical Trials in the Development of Vaccines for Infectious Diseases
  • 3.1 Types of Vaccines and Populations for Immunisation
  • 3.2 Staging Clinical Trials Throughout a Development Programme
  • 3.3 Immunogenicity
  • 3.3.1 Types of Antibody Assay
  • 3.3.2 How Antibody Values are Expressed
  • 3.3.3 What Does an Antibody Response Mean?
  • 3.3.4 CellularMethods for Assessing Immunogenicity
  • 3.3.5 Limits to Blood Sample Volumes
  • 3.3.6 Clinical Trials That Use Immunogenicity Endpoints
  • 3.4 Efficacy
  • 3.4.1 Defining Efficacy
  • 3.4.2 Defining Cases Within an Efficacy Trial
  • 3.4.3 Selection of Subjects for Efficacy Trials
  • 3.4.4 Efficacy Study Design
  • 3.4.5 Non-pivotal Efficacy Studies
  • 3.4.6 Controlled Human Infection Models
  • 3.5 Safety
  • 3.5.1 Reactogenicity
  • 3.5.2 Other Adverse Events
  • 3.6 Conclusion
  • Postscript
  • References
  • Chapter 4 Clinical Trials in Immunotherapeutic Vaccine Development

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