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PharmaFocus: Vaccine Adjuvants In Infectious Disease

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

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