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.

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