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Full Description
The book is essential for anyone interested in vaccine development, as it highlights the unique advantages of viral vector vaccines in triggering robust, long-lasting immunity and provides an in-depth exploration of the technology and advancements shaping the future of healthcare.
Viral vector vaccines have several unique advantages when compared to other vaccine platforms. These powerful vaccines are capable of triggering long-lasting cellular responses, such as cytotoxic T-lymphocytes, that eradicate virus-infected cells. Viral vector-based vaccines use a harmless virus to smuggle the instructions for making antigens from the disease-causing virus into cells, triggering protective immunity against them. In contrast to conventional antigen-containing vaccines, these vaccines use the body's natural defense system to produce antigens by using a modified virus to deliver genetic code for an antigen. Viral Vectors for Vaccine Delivery provides a comprehensive overview of viral vectors and their applications in vaccine delivery. Its chapters explore various aspects of viral vector technology, from the basic principles of viral vector construction to the latest advancements in gene editing and manufacturing.
Readers will find that the book
Offers a deep dive into the world of viral vectors, covering their principles, applications, and potential impact on healthcare;
Explores how viral vectors are revolutionizing vaccine development, providing a more effective and targeted approach to disease prevention;
Discusses the potential of viral vectors to address emerging health challenges and contribute to a healthier world.
Audience
Research scholars, pharma-process engineers, research scientists, pharmacy students and professionals from the pharmaceutical and biopharmaceutical industry interested in drug discovery, chemical biology, computational chemistry, medicinal chemistry, and bioinformatics
Contents
Preface xv
1 Introduction to Viral Vectors 1
Anjali P. Bedse, Suchita P. Dhamane, Shilpa S. Raut, Komal P. Mahajan and Kajal P. Baviskar
1.1 Introduction 2
1.2 Baculovirus Vectors 3
1.3 Adenovirus Vectors 4
1.4 Poxvirus Vectors 6
1.5 Herpes Virus Vectors 8
1.6 Epstein-Barr Virus Vectors 9
1.7 Retrovirus Vectors 10
1.8 Lentivirus Vectors 11
1.9 Adeno-Associated Virus (AAV) 13
1.10 Applications of Viral Vectors 14
1.10.1 Viral Vectors for Vaccine Development 14
1.10.2 Gene Therapy: The Performance of Viral Vectors 15
1.10.3 Clinical Trials 15
1.11 Safety Issues of Viral Vector/Biosafety Challenges 16
1.12 Conclusion 18
References 19
2 Viral Vector Construction 25
Suneetha Vuppu, Toshika Mishra, Shatakshi Mishra, Stany B. and Anushka Das
2.1 Introduction 26
2.2 Applications of Viral Vector 27
2.3 Viral Vectors 29
2.3.1 Adenoviruses 29
2.3.2 Retroviruses 35
2.3.3 Lentiviruses 36
2.3.4 Poxviruses 36
2.3.5 Adeno-Associated Viruses 37
2.3.6 Herpes Simplex Viruses 38
2.3.7 Alphaviruses 39
2.3.8 Flaviviruses 39
2.3.9 Rhabdoviruses 40
2.3.10 Newcastle Disease Virus 40
2.3.11 Coxsackieviruses 41
2.3.12 Measles Virus 41
2.4 Construction of Viral Vectors 42
2.5 Challenges 46
2.5.1 Immune Response 46
2.5.2 Specificity of the Transgene Delivery 47
2.5.3 Insertional Mutagenesis 48
2.6 Advancements in Technology of Viral Vector Construction 49
2.7 Conclusion and Future Prospects 51
Acknowledgments 53
References 53
3 The Role of Adjuvants in the Application of Viral Vector Vaccines 65
Vivek P. Chavda, Anjali P. Bedse and Shilpa S. Raut
3.1 Introduction 66
3.2 Viral Vector Vaccines: A Powerful Platform 67
3.3 Challenges Associated with Viral Vector Vaccines 69
3.3.1 Preexisting Immunity against the Viral Vector 69
3.3.2 Safety Concerns Related to Insertional Mutagenesis 70
3.3.3 Scalability and Manufacturing Challenges 72
3.4 The Role of Adjuvants in Overcoming Challenges 72
3.4.1 Mechanisms of Action of Adjuvants 72
3.4.2 Innate Immune Stimulation 73
3.4.3 Adaptive Immune Response Enhancement 73
3.4.4 Different Classes of Adjuvants Used with Viral Vector Vaccines 74
3.4.4.1 Classes of Adjuvants 74
3.4.5 Targeting CLR Pathway 75
3.4.6 Saponins 75
3.4.7 Cytokines and Chemokines 76
3.4.8 Case Studies of Specific Adjuvants Used with Viral Vector Vaccines 76
3.5 Optimizing Adjuvant Design for Viral Vector Vaccines 76
3.5.1 Importance of Adjuvant Selection and Formulation 76
3.5.2 Adjuvant Formulation Development 77
3.5.3 Adjuvant Formulations for the Development of New Vaccines 77
3.5.4 Strategies for Optimizing Adjuvant Design 78
3.5.4.1 Dose Sparing 78
3.5.4.2 Enabling a More Rapid Immune Response 78
3.5.4.3 Antibody Response Broadening 78
3.5.4.4 Antibody Response Magnitude and Functionality 79
3.5.5 Delivery Systems 79
3.5.5.1 Targeting Specific Immune Cell Populations 79
3.5.5.2 Combination Adjuvants 79
3.5.5.3 Challenges and Future Directions in Adjuvant Development for Viral Vector Vaccines 80
3.6 Conclusion 80
References 81
4 Replication-Competent Viral Vectors for Vaccine Delivery 91
Vivek P. Chavda, Pankti C. Balar, Dixa A. Vaghela, Divya Teli, Amit Chaudhari and Shahnaz Alom
4.1 Introduction 92
4.2 Types of Replication-Competent Viral Vectors 93
4.2.1 Adenoviruses (AdVs) 93
4.2.2 Vesicular Stomatitis Viruses (VSVs) 93
4.2.3 Modified Vaccinia Ankara (MVA) 94
4.2.4 Measles Virus (MV) 94
4.2.5 Influenza Virus (IV) 95
4.3 Mechanisms of RCVV-Mediated Vaccination 97
4.4 Applications of Replication-Competent Viral Vectors 101
4.4.1 Prophylactic Vaccines 101
4.4.2 Therapeutic Vaccines 102
4.4.2.1 Vesicular Stomatitis Virus 102
4.4.2.2 Cytomegalovirus 103
4.4.2.3 Measles Virus 104
4.4.2.4 Adenoviral Vectors 104
4.4.2.5 Applications of Replication-Competent Viral Vectors against COVID- 19 105
4.4.3 Cancer Immunotherapy 111
4.5 Conclusion 115
References 116
5 Nonreplicating Viral Vectors for Vaccine Delivery 125
Pankti C. Balar and Vivek P. Chavda
5.1 Introduction 126
5.2 Nonreplicating Viral Vectors: Types and Characteristics 127
5.2.1 Adenoviral Vectors 127
5.2.2 Non-Adenoviral Vectors 128
5.2.3 Key Characteristics of Nonreplicating Vectors 129
5.2.3.1 Immunogenicity 129
5.2.3.2 Safety 130
5.2.3.3 Stability 131
5.2.3.4 Targeted Delivery 131
5.3 Engineering Nonreplicating Viral Vectors for Vaccine Design 132
5.3.1 Capsid Modification 132
5.3.2 Promoter Engineering 133
5.3.3 Transgene Optimization 134
5.3.4 Immune Evasion Strategies 134
5.4 Applications of Nonreplicating Viral Vectors in Vaccinology 136
5.5 Optimizing Nonreplicating Viral Vectors for Vaccine Delivery 138
5.5.1 Enhancing Transduction Efficiency 138
5.5.2 Reducing Immunogenicity and Toxicity 139
5.5.3 Improving Antigen Expression and Presentation 139
5.5.4 Addressing Preexisting Immunity 140
5.5.5 Targeting Vector Delivery to Secondary Lymphoid Organs 141
5.6 Challenges and Future Perspectives 141
5.7 Conclusion 143
References 144
6 Genetically Modified Viral Vectors for Vaccine Delivery 149
Deepshi Arora, Yugam Taneja, Diksha Gulati, Manish Kumar, Anil Pareek and Rupesh K. Gautam
6.1 Introduction 150
6.2 Genetic Modification of Viral Vectors 153
6.3 Applications of Genetically Modified Viral Vectors 155
6.4 Administration of Vaccines 159
6.5 Immune Response and Protection 161
6.6 Case Studies 163
6.7 Challenges and Future Directions 165
6.8 Conclusion 168
References 171
7 DNA- and RNA-Based Viral Vectors 179
Devesh U. Kapoor, Bhumi Bhatt, Dipansu Sahu, Rajiv R. Kakkar, Sonam M. Gandhi and Rupesh K. Gautam
7.1 Introduction to Viral Vectors 180
7.1.1 Definition and Overview 180
7.1.2 Importance in Vaccine Delivery and Vaccination 180
7.2 Basics of Deoxyribonucleic Acid (DNA) and Ribonucleic Acid (RNA) Viruses 180
7.2.1 Structure and Replication of DNA Viruses 181
7.2.2 Structure and Replication of RNA Viruses 181
7.2.3 Characteristics Relevant to Vector Development 182
7.2.3.1 Plasmids 182
7.2.3.2 Viral Vectors 183
7.2.3.3 Artificial Chromosomes 183
7.3 DNA-Based Viral Vectors 183
7.3.1 Adenoviral Vectors 183
7.3.1.1 Advantages and Limitations of Adenoviral Vectors 185
7.3.1.2 Adenoviral Vectors Applications in Vaccination 186
7.3.2 Lentiviral Vectors 187
7.3.2.1 Advantages and Limitations of Lentiviral Vectors 188
7.3.2.2 Lentiviral Vectors Applications in Vaccination 189
7.3.3 Adeno-Associated Viral Vectors 190
7.3.3.1 Advantages and Limitations of AAV 190
7.3.3.2 AAV Applications in Gene Therapy and Vaccination 191
7.3.4 Other DNA-Based Viral Vectors 193
7.3.4.1 Baculoviral Vectors 193
7.3.4.2 Herpes Simplex Virus Vectors 193
7.3.4.3 Poxviral Vectors 193
7.4 RNA-Based Viral Vectors 194
7.4.1 Retroviral Vectors 194
7.4.1.1 Advantages and Limitations 195
7.4.2 Lentiviral Vectors 196
7.4.2.1 Advantages and Limitations 197
7.4.3 Alphaviral Vectors 201
7.4.3.1 Advantages and Limitations 201
7.4.4 Other RNA-Based Viral Vectors 203
7.4.4.1 Sendai Virus Vectors 204
7.4.4.2 Vesicular Stomatitis Virus Vectors 205
7.5 Vector Engineering and Modifications 205
7.5.1 Enhancing Vector Safety 206
7.5.2 Improving Vector Targeting and Tropism 207
7.5.3 Regulatory Considerations and Quality Control 207
7.6 Preclinical and Clinical Applications 208
7.6.1 Gene Therapy Applications 209
7.6.1.1 Inherited Disorders 209
7.6.1.2 Neurological Disorders 210
7.6.2 Vaccination Applications 210
7.6.2.1 Viral Vector-Based Vaccines 210
7.6.2.2 Genetic Vaccines 212
7.7 Conclusion 212
References 213
8 Manufacturing and Control of Viral-Vector Vaccines: Challenges 221
Vivek P. Chavda, Dixa A. Vaghela, Dhunusmita Barman, Arzoo Newar and Ahmed Nasima
8.1 Introduction 222
8.2 Fundamentals of Viral-Vectored Vaccine Manufacturing 223
8.2.1 Viral Vector Construction 223
8.2.2 Development of the Viral Vector in Bacteria Through Homologous Recombination 224
8.2.2.1 Production of the Viral Vector Using Cre/loxP Recombination System 224
8.2.3 Cell Line Development 224
8.2.3.1 Designer Cell Lines and Cell Line Immortalization 225
8.2.3.2 Development of Stable Cell Lines for Vaccine Constitutive Expression 226
8.2.4 Upstream Processing 226
8.2.4.1 Cultivation Process and Harvest Timing of the Virus 226
8.2.5 Downstream Processing 227
8.2.5.1 Purification of Viral Vectors 227
8.2.5.2 Purification of a Large Stock of Viral Vector 227
8.2.5.3 Purification of Viral Vectors Using CsCl Density Gradient Centrifugation 228
8.2.5.4 Stable Liquid Virus Formulation Development 228
8.3 Challenges in Manufacturing Viral-Vectored Vaccines 229
8.3.1 Scale-Up and Production Yield Challenges 229
8.3.2 Ensuring Genetic Stability and Vector Integrity 230
8.3.3 Manufacturing Consideration for Different Vector Types 234
8.4 Quality Control and Assurance in Vaccine Manufacturing 235
8.4.1 Regulatory Requirements and Quality Standards 236
8.4.2 Analytical Methods for Assessing Viral Vector Purity and Potency 237
8.4.3 Process Validation and Quality Assurance Strategies 238
8.4.3.1 Process Validation Using a Life Cycle Approach: From R&D to Clinical Trials to Commercial Scale Regulation 239
8.4.3.2 Validation Strategy Based on Risk: Quality Risk Management System 239
8.5 Technological Advances and Innovations in Manufacturing 239
8.5.1 Novel Manufacturing Platforms and Technologies 239
8.5.2 Automation and Process Optimization 243
8.6 Supply Chain and Distribution Challenges 244
8.7 Regulatory Hurdles and Compliances 246
8.7.1 Regulatory Approval Challenges 246
8.7.2 Compliances with Good Manufacturing Practices (gmp) 246
8.7.3 Strategies for Navigating Regulatory Pathways 247
8.8 Future Perspectives and Emerging Solutions 248
8.9 Conclusion 248
References 249
9 Viral Vectors in Veterinary Vaccine Development 257
Anup Kumar, Pooja Pandita, Harsh Modi, Shahnaz Alom and Vivek P. Chavda
9.1 Introduction 258
9.2 Basics of Viral Vectors 259
9.2.1 Definition and Characteristics of Viral Vectors 259
9.2.2 Types of Viral Vectors Used in Veterinary Vaccines 260
9.2.3 Advantages and Limitations of Viral Vectors 261
9.3 Genetic Engineering of Viral Vectors 262
9.3.1 Design and Construction of Viral Vectors 262
9.3.1.1 Gene Insertion Techniques 262
9.3.1.2 Promoters and Enhancers 262
9.3.2 Safety Measures and Biosafety Considerations 263
9.3.3 Quality Control and Characterization 263
9.4 Delivery System for Viral Vector Vaccines 265
9.4.1 Application of Nanotechnology in Vaccine Delivery 265
9.4.2 Targeted Delivery Approaches: Viral Vectors as Nanocarriers for Targeted Mucosal and Systemic Vaccine Delivery System 267
9.4.3 Novel Delivery Platforms and Technologies 268
9.4.3.1 Transdermal Vaccine Delivery System 268
9.4.3.2 Microneedle Arrays Delivery System for Viral Vector Vaccine 269
9.4.3.3 Viral Vector for DNA Vaccine Delivery 270
9.4.3.4 Needle-Free Vaccination for Viral Vector Vaccine Delivery 271
9.4.3.5 Combination Vaccine Regimen for Viral Vector Vaccine Delivery 272
9.5 Routes of Administration for Viral Vector Vaccines 272
9.5.1 Parenteral Route of Administration 273
9.5.1.1 Intravenous Route 273
9.5.1.2 Intramuscular Route 273
9.5.1.3 Subcutaneous Route 274
9.5.1.4 Intradermal Route 274
9.5.2 Mucosal Route of Administration 274
9.5.2.1 Intranasal Route 275
9.5.2.2 Oral Route 276
9.6 Comparative Analysis of Different Administration Routes 276
9.6.1 Parenteral Vaccine Delivery System 276
9.6.2 Mucosal Vaccine Delivery System 277
9.6.3 Challenges of the Mucosal Delivery System 278
9.6.3.1 Advantages of the Oral Route 278
9.6.3.2 Challenges of Oral Route 279
9.6.3.3 Advantages of Intranasal Route 279
9.6.3.4 Challenges of Intranasal Route 279
9.7 Applications of Viral Vectors in Veterinary Vaccine Development 280
9.7.1 Live Attenuated Viral Vector Vaccines 280
9.7.2 Inactivated Viral Vector Vaccines 280
9.7.3 DNA-Based Viral Vector Vaccines 281
9.7.4 Subunit Viral Vector Vaccines 281
9.7.5 Recombinant Viral Vector Vaccines 282
9.7.6 Examples of Veterinary Vaccines Using Viral Vectors 282
9.8 Immunology and Immune Response 285
9.8.1 Mechanisms of Immune Response to Viral Vector Vaccines 285
9.8.2 Adjuvants and Immune Enhancement 286
9.8.3 Immune Memory and Longevity 287
9.9 Safety and Regulatory Considerations 291
9.9.1 Safety Assessment and Preclinical Studies 291
9.9.2 Regulatory Approval Process for Veterinary Viral Vector Vaccines 292
9.9.3 Post-Market Surveillance and Monitoring 293
9.10 NotableExamples of Viral Vector Vaccines in Veterinary Medicine and Their Impact on Animal Health and Agriculture 295
9.11 Challenges and Future Directions 297
9.12 Conclusion 299
References 300
10 Advantages and Challenges of Viral Vector Vaccines 317
Shilpa Dawre, Mahendra Prajapati and Ganesh Shevalkar
10.1 Introduction 317
10.2 Types of Viral Vectors for Vaccine Development 319
10.2.1 Poxviruses Vectors 319
10.2.2 Adenovirus Vectors 322
10.2.3 Retrovirus Vectors 322
10.2.4 Lentivirus Vectors 323
10.2.5 Cytomegalovirus Vectors 323
10.2.6 Sendai Virus Vectors 323
10.2.7 Adeno-Associated Virus Vectors 324
10.3 Mechanism of Action of Viral Vectors 324
10.3.1 Self-Adjuvanting Nature of Viral Vector Vaccines 325
10.3.2 Enhanced Cytotoxic CD8 + T Lymphocyte Production 326
10.3.3 Conformational Antigen Expression on Host Cell Membranes Infected by a Vector 327
10.3.4 Sustained Supply of Significant Amounts of Antigen 327
10.4 Advantages of Viral Vector Vaccines 327
10.4.1 Safety 328
10.4.2 Stability 328
10.4.3 Immunogenicity 328
10.4.3.1 Humoral Immunity 329
10.4.3.2 Cell-Mediated Immunity 329
10.4.3.3 Mucosal Immunity 330
10.5 Challenges of Viral Vector Vaccine 331
10.5.1 Development of Immunity Against Viral Vectors 331
10.5.2 Adverse Events 331
10.5.3 Scale-Up Hurdles in Viral Vector Production 332
10.5.3.1 Complexity and Variability of the Process 332
10.5.3.2 Low Yield and High Cost 333
10.5.3.3 Regulatory and Quality Control Challenges 333
10.5.3.4 Restrictions of Frequent Culture Systems 334
10.5.3.5 Formulation and Storage of Viral Vector Products 334
10.5.3.6 Requirement of High-Cost Technologies 335
10.5.3.7 Handling and Shipment 335
10.6 Conclusion 336
References 336
11 Commercially Available Viral Vectors and Vaccines 341
Vasso Apostolopoulos, Pankti C. Balar, Arun Kumar Singh and Vivek P. Chavda
11.1 Introduction 342
11.2 Viral Vector-Based Vaccines, Licensed for Humans 342
11.2.1 Adenovirus Vector Vaccines 342
11.2.2 Vesicular Stomatitis Virus Vector Vaccines 346
11.2.3 Flavivirus Vector Vaccines 347
11.2.4 Combination Virus Vectors: Ad5/Ad 26 348
11.2.5 Combination Virus Vectors: Ad5/VSV 348
11.2.6 Measles Virus Vector Vaccines 349
11.2.7 Poxvirus Vector Vaccines 349
11.3 Conclusion 350
References 350
12 Emerging Viral-Vector Technologies: Future Potential 357
Vasso Apostolopoulos, Pankti C. Balar and Vivek P. Chavda
12.1 Introduction 358
12.2 New Emerging Viral Vectors for Vaccines 358
12.3 Viral Vector Vaccines: What is Good and What is Not So Good 360
12.4 Conclusion 361
References 361
Index 365
