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PharmaFocus: Vaccine Adjuvants in Infectious Disease
Date:4/11/2013

nvaccinated 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 <
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