PharmaFocus: Vaccine Adjuvants in Infectious Disease

  • March 2013
  • -
  • Global Data
  • -
  • 87 pages

PharmaFocus: Vaccine Adjuvants in Infectious Disease



Summary



Originally discovered by Glenny in the 1920s, vaccine adjuvants have remained the pharmaceutical industry’s “dirty little secret”. Today, vaccine adjuvants are credited with helping to bolster the immune response in the host post-vaccination. Recently, second-generation adjuvants have come under scrutiny after reports that the adjuvant used in certain pandemic influenza vaccines was linked to causing narcolepsy in Swedish and British adults. Such reports, compounded by the general mistrust of adjuvants, have resulted in these vital vaccine components becoming the scapegoat of the vaccine industry. However, immunologists and infectious disease specialists are in agreement over the beneficial uses of adjuvants in vaccines today, especially as a means to reduce the number of doses, increase the likelihood of a sustained immunological response and decrease the overall incidence of disease.



Scope


- Overview of vaccine adjuvants, including the host immune system, host cell targets, descriptions of different adjuvant classes and regulatory guidelines to seek approval for adjuvanted vaccines.
- Key topics covered include vaccines and the host immune response, adjuvant targets, and current adjuvant options (first and second generation) for the vaccine adjuvant market.
- Analysis of the current and future market competition in the vaccine adjuvant market. Insightful review of the key industry and governmental drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.



Reasons to buy


- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
- Develop business strategies by understanding the trends shaping and driving the global vaccine adjuvant market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global vaccine adjuvant market in future.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table Of Contents

Table of Contents

1 Table of Contents 5
1.1 List of Tables 8
1.2 List of Figures 9
2 Introduction 10
2.1 Catalyst 10
3 Vaccines and the Host Immune Response 11
3.1 Vaccines in Infectious Disease 11
3.2 Host Immune Response 12
3.2.1 Primary Barriers Against Infection 12
3.2.2 Innate Immune System 13
3.2.3 Adaptive Immune System 15
3.3 Vaccine Adjuvants 18
3.3.1 Overview 18
3.3.2 Adjuvant Target: Dendritic Cells 19
3.3.3 Adjuvant Target: Toll-Like Receptors 22
3.3.4 Splenic Involvement in Immune Response 25
3.3.5 Antigen-Depot Effect 25
4 Market Drivers and Barriers 27
4.1 Overview 27
4.2 Drivers 28
4.2.1 Driver: Government initiatives to increase vaccination programs 28
4.2.2 Driver: New routes of administration for vaccines 29
4.2.3 Driver: Rapidly mutating pathogens 29
4.2.4 Driver: Recombinant vaccine technology 30
4.2.5 Driver: Increased research efforts against unvaccinated disease 30
4.3 Barriers 31
4.3.1 Barrier: Decreasing or stagnant vaccination rates 31
4.3.2 Barrier: Increasing vaccine prices 32
4.3.3 Barrier: Public opinion of vaccine and adjuvants 33
5 Current Adjuvant Options 34
5.1 Overview 34
5.2 Product Profiles - Major Adjuvant Classes 37
5.2.1 Aluminum Salts (Alum) 37
5.2.2 Emulsions 40
5.2.3 Particulate Delivery Mechanisms 43
5.2.4 Microbial Derivatives 46
5.2.5 Oligonucleotides 49
5.2.6 Adjuvant Systems 52
6 Needs Assessment and Opportunity Analysis 56
6.1 Overview 56
6.2 Unmet Needs Analysis 57
6.2.1 Adjuvant Safety 57
6.2.2 DC Recognition 57
6.2.3 Appropriate TLR Activation 58
6.2.4 Formulation and Dosing 58
6.3 Opportunity Analysis 60
6.3.1 Novel Routes of Administration and Splenic Involvement 60
6.3.2 Combinatorial Adjuvant Systems 61
6.3.3 Limited Use of Antigen Depot 61
7 Clinical Trials and Regulatory Strategy 63
7.1 Clinical Trial Design 63
7.1.1 Non-clinical Evaluation 63
7.1.2 Adjuvant Mechanism of Action Evaluation 64
7.1.3 Clinical Safety Evaluation 64
7.1.4 KOL Opinion on Clinical Design 65
7.2 Regulatory Strategy 67
7.2.1 Overview 67
7.2.2 World Health Organization (WHO) 68
7.2.3 US 69
7.2.4 EU 73
7.2.5 Cultural Differences in Adjuvant Use (US vs. Europe) 73
8 Appendix 75
8.1 Bibliography 75
8.2 Abbreviations 81
8.3 Research Methodology 82
8.4 Physicians and Specialists Included in this Study 83
8.5 About the Authors 85
8.5.1 Author 85
8.5.2 Reviewer 85
8.5.3 Global Head of Healthcare 86
8.6 About GlobalData 86
8.7 Contact Us 86
8.8 Disclaimer 87



List of Tables

Table 1: Primary Physical (Epithelial) Barriers to Infection 12
Table 2: Immune Cells and Their Corresponding Toll-like Receptors 15
Table 3: TLR Adjuvant Targets and Ligand Types in Clinical Trials for Infectious Disease Vaccines 24
Table 4: Vaccine Adjuvants - Drivers and Barriers, 2013 27
Table 5: Leading Adjuvants in Clinical Trials for Human Infectious Disease Vaccines 36
Table 6: Product Profile - Aluminum Salts/Alum 38
Table 7: Aluminum Salts/Alum SWOT Analysis, 2013 40
Table 8: Product Profile - Emulsions 42
Table 9: Emulsions SWOT Analysis, 2013 43
Table 10: Product Profile - Particulate Delivery Mechanisms 45
Table 11: Particulate Delivery Mechanisms SWOT Analysis, 2013 46
Table 12: Product Profile - Microbial Derivatives 48
Table 13: Microbial Derivatives SWOT Analysis, 2013 49
Table 14: Product Profile - Oligonucleotides 50
Table 15: Oligonucleotides SWOT Analysis, 2013 52
Table 16: Product Profile - Adjuvant Systems 53
Table 17: GSK’s Adjuvant System Portfolio, 2013 53
Table 18: Adjuvant Systems SWOT Analysis, 2013 55
Table 19: Overall Unmet Needs - Current Level of Attainment 56
Table 20: Regulatory Guidelines for the Approval of Adjuvanted Vaccines 72



List of Figures

Figure 1: Immune System - Stimulation of Innate and Adaptive Responses 13
Figure 2: Adjuvant Targets - Human Toll-like Receptor Family 23
Figure 3: Adjuvant - Host Immune Response Interactions 35
Figure 4: Chemical Structure of MPL 47
Figure 5: Chemical Structure of Dinitrophenylated CpG ODN 50
Figure 6: WHO Map to Vaccine Adjuvant Usage 69

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