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Stakeholder Opinions: HIV Vaccines - The Emperor Has No ClothesPublished by: Datamonitor Published: Dec. 21, 2004 - 194 Pages Table of ContentsTABLE OF CONTENTS CHAPTER 1 EXECUTIVE SUMMARY 3 Scope of the analysis 3 Datamonitor insight into the HIV vaccines market 4 Despite the success of antiretroviral (HAART) therapy in reducing HIV/AIDS related mortality in the developed world; it is becoming clear that a similar impact is not achievable in the developing world where disease burden is highest. The historical success of vaccination as a tool to provide healthcare benefit ‘en masse’ therefore continues to spur the development of a safe and effective HIV vaccine 4 Early monomeric recombinant subunit strategies, whilst optimistic have helped garner research momentum, raise public awareness and provide useful lessons for later generation candidates. Whilst approaches such as DNA, live vector and pseudovirion vaccines are providing some hope, there is now a shift towards combinations to best target separate immune responses and different HIV subtypes 7 With each increasing compromise to the concept of an ‘ideal HIV vaccine’ it is clear that additional non-clinical challenges present themselves. With attributes such as ‘partial efficacy’ and ‘limited protection’ being espoused as more realistic goals, deciding who would most benefit from a suboptimal vaccine requires strong judgment and skillful implementation; 11 The success of HIV vaccines is dependent on cost, target population and governmental support for immunization. This uncertainty, combined with economic and political considerations, is limiting commercial investment in future research. Clarity and support from supra-national organizations and governments on these issues, especially tiered pricing, must be provided. 13 Summary 16 CHAPTER 2 HIV VACCINES: AN INTRODUCTION 24 Background 24 The HIV virus: genetic variability creates a complex target 25 Superinfection 26 Which immune response to target? 27 Will HIV vaccination be effective? 27 A predictive animal model? 28 Non-clinical issues also exert an influence 31 Current approaches to HIV vaccines 31 Recombinant subunit vaccines 32 Protein vaccines 33 Peptide-based vaccines 36 Pseudovirion/virus-like particle vaccines 38 Prime-boost vaccines 38 Live vector vaccines 39 Pox viruses 40 Adenovirus 41 Rabies and other viruses 41 Live attenuated vaccines 42 DNA-based vaccines 43 Inactivated/whole killed HIV vaccines 44 Summary of approaches currently being investigated 46 Key stakeholders 47 The International AIDS Vaccine Initiative (IAVI) 47 National Institute of Allergy and Infectious Diseases (NIAID) 48 European Vaccine Effort against HIV/AIDS 49 HIV Vaccine Trials Network (HVTN) 50 South African AIDS Vaccine Initiative (SAAVI) 50 The Global HIV Vaccine Enterprise 51 CHAPTER 3 DEVELOPMENT AND PROGRESS 53 Timeline of the development of HIV vaccines 53 The need for global cooperation 54 The pipeline - an overview 55 AIDSVAX 59 AIDSVAX B/B 60 AIDSVAX B/E 61 ALVAC 63 vCP125 63 vCP205 64 vCP300 66 vCP1433 66 vCP1521 67 St. Jude Children’s Research Hospital 69 PolyEnv1 69 EnvPro 70 Current status 70 Merck & Co. 71 MRKAd5 HIV-1 gag 71 MRKAd5 HIV-1 trivalent 73 HIV-1 gag DNA vaccine 74 Future prospects 75 Partial efficacy 75 Protection for all? 77 Protection against infection or disease? 78 Social impact of a partially effective vaccine 79 CHAPTER 4 KEY CHALLENGES AND ISSUES 81 Ethical considerations 81 Which subtype to target? 82 Protection of the individual throughout the trial 83 Social, psychological and emotional harm 83 Treatment and care for those who become infected in the trial 84 Risk behavior - should it be prevented? 85 Societal considerations 86 Clinical trial considerations 87 Trial population - HIV-infected or negative? 88 Trial location - developed or developing world? 89 Trial size and duration 91 Attitudes to vaccination 93 Target population 94 Moral issues 98 Mandatory or voluntary? 99 Payment 102 Economic and financial considerations 104 Current investment in HIV vaccine development 107 Public versus private investment 107 One single goal but many different approaches 109 Political considerations 113 Legal barriers 115 Regulatory issues 116 Tiered prices 116 Intellectual property 118 CHAPTER 5 COMMERCIAL IMPLICATIONS OF SUCCESS 120 An ideal HIV vaccine? 120 Pricing and reimbursement considerations 122 Implications for antiretroviral therapy 125 Epidemiological overview 127 CHAPTER 6 OPINION LEADER TRANSCRIPTS 131 US opinion leader 131 Section 1 - Vaccine technologies 131 Section 2 - The current pipeline 137 Section 3 -Obstacles to the development of an HIV vaccine 138 Section 4 -An ideal HIV vaccine 140 Section 5 - Trial considerations 141 Section 6 - Target population and immunization schedule 142 Section 7 - Compliance and patient attitudes 143 Section 8 - Therapeutic vaccines 144 French opinion leader 146 Section 1 - Vaccine technologies 146 Section 2 - The current pipeline 149 Section 3 -Obstacles to the development of an HIV vaccine 151 Section 4 -An ideal HIV vaccine 153 Section 5 - Trial considerations 154 Section 6 - Target population and immunization schedule 155 Section 7 - Compliance and patient attitudes 157 Section 8 - Therapeutic vaccines 157 German opinion leader 159 Section 1 - Vaccine technologies 159 Section 2 - The current pipeline 162 Section 3 -Obstacles to the development of an HIV vaccine 164 Section 4 -An ideal HIV vaccine 166 Section 5 - Trial considerations 167 Section 6 - Target population and immunization schedule 168 Section 7 - Compliance and patient attitudes 169 Section 8 - Therapeutic vaccines 170 APPENDIX A ADDITIONAL DATA 172 APPENDIX B GLOSSARY AND ASSUMPTIONS 179 Glossary 179 Assumptions 180 APPENDIX C BIBLIOGRAPHY 181 Journal & news articles 181 Other articles and publications 190 Other sources 192 Websites 192 Disclaimer 194 AbstractIntroductionIn December 2004, 35.9-44.3 million individuals were currently living with HIV/AIDS. In the same year, 2.8-3.5 million had reportedly died with a further 4.3-6.4 million new infections (UNAIDS). HIV penetrates marginalized population groups such as women who sell sex, IVDUs and homosexual men. Most are likely to exacerbate viral spread and are furthest from available support. Scope In depth overview and case record of the main approaches to HIV vaccine research and development Discussion of key challenges within HIV virology and current understanding of human immunology that have limited current progress In depth analysis of clinical, societal and political factors and how they affect HIV vaccine profile and its subsequent adoption Comment on quantitative potential in each population target group across major Western markets Highlights Despite the success of antiretroviral (HAART) therapy in reducing AIDS related mortality in the developed world, it is becoming clear that to achieve the same impact in poorer countries an additional healthcare intervention such as vaccination will be necessary. Early monomeric recombinant subunit strategies, whilst optimistic have helped garner research momentum and public awareness as well as providing useful lessons for later generation approaches using live recombinant vectors. Shifting expectations of vaccination, the identification of appropriate trial populations and ethical considerations must be addressed throughout the research, testing and eventual launch process to ensure optimal uptake. Reasons to Purchase Understand the strengths and weaknesses associated with differing HIV vaccination strategies Understand critical factors affecting feasibility and logistics of conducted human clinical trials for HIV vaccines Assess relative importance of HIV vaccine profile components and how they affect future adoption Get Full Details About This Report >> |
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