Despite 25 years of extensive research, an HIV vaccine remains an elusive target. More-innovative approaches to vaccine development are urgently needed. Although this high-risk, high-profi le area of development is crucial to world health, it is unlikely to offer fi nancial rewards for Big Pharma. Therefore, smaller biotechs and charitable organizations also play key roles.

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The recent failure of Merck' s T-cell vaccine for HIV may mark a turning point in HIV development across the industry. Which other HIV vaccines in the pipeline use this same approach? What other approaches to vaccine development might offer greater potential for success in the future?
Despite the critical importance of addressing the HIV pandemic, the market potential of a vaccine will be limited in the near term. Where is the greatest market potential? What strategies are pharmaceutical and biotech companies pursuing to solve this world health problem while also maximizing returns?
Given the market limitations associated with HIV vaccine development, government and charitable organizations are funding many of the development efforts. Which organizations are providing the greatest amount of funding? How is the pharmaceutical industry working with these organizations to achieve scientifi c breakthroughs and gain a competitive advantage?

Scope

Understanding HIV: background on the virus, the immune response, the need for a vaccine.
HIV market: market potential, possible target populations, challenges, strategic considerations.
Current approaches to vaccine design: neutralizing antibodies, cell-mediated immunity.
Current vaccine candidates: recombinant viral vectors, DNA vaccines, recombinant proteins, peptides and lipopeptides.
Future approaches to vaccine design: mucosal immunity, recombinant vectors, virus-like particles, live attenuated vaccines, whole inactivated viral vaccines, synthetic peptide immunogens, gene therapy, antisense oligonucleotides.
Outlook: Big Pharma, biotech companies, governments, charitable organizations.

Executive Summary
- Strategic Considerations
- Stakeholder Implications
Introduction
Understanding the Need for Vaccination Against HIV
- The Virus
- The Immune Response
- The Need for an HIV Vaccine
Market Potential of an HIV Vaccine
Challenges and Strategic Considerations in Developing an HIV Vaccine
Current Approaches to Vaccine Design
- Neutralizing Antibodies
- Cell-Mediated Immunity
Current Vaccine Candidates
- Recombinant Viral Vectors
  - Adenoviral Vectors
  - Canarypox Vectors
  - Modifi ed Vaccinia Vectors
  - Fowlpox Viral Vectors
- DNA Vaccines
- Recombinant Proteins
- Peptides and Lipopeptides
Future Approaches to Vaccine Design
- Harnessing Mucosal Immunity
- Recombinant Vectors
- Virus-Like Particles
- Live, Attenuated Vaccines
- Whole, Inactivated Viral Vaccines
- Synthetic Peptide Immunogens
- Gene Therapy
- Antisense Oligonucleotides
Outlook
- Outlook for Large Pharmaceutical Companies
- Outlook for Biotechnology Companies
- Role of Philanthropic Organizations