Executive Summary
Chapter 1
INTRODUCTION
1.1. Before the Cure There Was Protection
1.2. Mechanisms of Immunity
1.3. The Universe of Vaccines
Chapter 2
PREVENTIVE VACCINES
2.1. The Infectious Disease Vaccine Industry: Special in Every WayHow Vaccines Are Different
2.2. The Main Types of VaccinesDNA Vaccines: The Third Generation
2.3. Regulatory Handling of VaccinesVaccine Testing and Approval in the United States
Vaccine Regulation in Europe
No Generics with Vaccines
2.4. Diseases and the State of Available VaccinesBacterial Infections
Viral Infections
Hepatitis
Influenza
Poliomyelitis
Rabies
Spreading Tropical Viruses
Japanese Encephalitis Virus
Human Immunodeficiency Virus and AIDS
Malaria
2.5. The Corporate PlayersLarge Pharmaceutical Players in the Vaccine Business
Baxter Vaccines
GlaxoSmithKline Vaccines
Johnson & Johnson Center for Vaccines
Novartis Vaccines and Diagnostics GmbH & Co. KG
Pfizer Vaccines
Sanofi Pasteur MSD
Small Vaccine Specialist Companies
AlphaVax
Bavarian Nordic
Bionor Pharma
ChronTech Pharma
DynPort Vaccine Company
Emergent BioSolutions
EpiVax
Genocea Biosciences
GenVec
Inovio Pharmaceuticals
Intercell
Medicago
MedImmune Vaccines
Mymetics
Novavax
Sinovac Biotech
Synthetic Genomics Vaccines
VaxInnate
Vical
2.6. Global InitiativesThe WHO Initiative for Vaccine Research (IVR)
The Global Alliance for Vaccines and Immunization (GAVI)
The Bill & Melinda Gates Foundation
The United Nations Children's Fund (UNICEF)
Pediatric Vaccines: A Multivalent Universe
2.7. The Market for Infectious Disease VaccinesIntellectual Property and the Vaccine Market
Mixed Prospects for an HIV Vaccine
2.8. Opposition to Vaccination: A Persistent PhenomenonThe Coalition for Vaccine Safety (CVS)
2.9. Vaccine Design, Formulation, and DeliveryGenetic Engineering and Rational Design of Antigens
Increasing Efficacy of DNA Vaccines
The Adjuvant Revolution: Nanoparticulate Vaccines and ISCOM Technologies
Intradermal and Needle-Free Transdermal Delivery
Oral Vaccines: From Niche Toward Mainstream
2.10. Infectious Disease Vaccines in a Globalized WorldInternational Travel, Migration, and Climate Change Drive New Vaccine Demands
SARS: A Model Event for an Emerging Pandemic Virus
Influenza: The Big Pandemic Continues to Loom
Planning and Logistics of Modern Mass Vaccination Campaigns
Bioterrorism and Biowarfare: Countermeasures for "The Next Very Bad Thing"
2.11. The Challenge of the ParasitesWhy Vaccination Against Parasites Is Difficult
The Quest for a Malaria Vaccine
Schistosomiasis
Neglected Tropical Diseases and the Major Pharma Markets
Chapter 3
THERAPEUTIC VACCINES
3.1. A Continuum with Immunotherapies
3.2. Postexposure Therapy for Viral DiseasesHepatitis C: Therapeutic Hopes in the Absence of Protection
AIDS: Still the Hotbed for Therapeutic Vaccine Development
3.3. Potential Vaccination Targets Outside the Mainstream: Autoimmune Diseases and BeyondAsthma and Allergy
Autoimmune Conditions: Type 1 Diabetes, Psoriasis, Arthritis, Multiple Sclerosis, and Transplant Rejection
Type 1 Diabetes
Multiple Sclerosis
Rheumatoid and Psoriatic Arthritis
Atherosclerosis
Periodontitis
Transplant Rejection
Alzheimer's Disease
3.4. The Most Unlikely Vaccine TargetsDrug Abuse and Smoking
Limited Hopes for Obesity
Cachexia
Macular Degeneration
Chapter 4
CANCER VACCINES
4. 1. Objectives and Criteria for a Cancer VaccineProphylaxis and Therapy Rolled into One
Therapeutic Cancer Vaccines: Breaking Immune Tolerance
Cancer Vaccines and Regulatory Authorities
4.2. The Status Quo: Cancer Vaccines Approved in the United States and ElsewhereGardasil and Cervarix to Prevent Cervical Cancer
Provenge for Prostate Adenocarcinoma
OncoVAX to Prevent Colon Cancer Recurrence
Melacine for Melanoma
Oncophage
CimaVax EGF
4.3. Cancer Vaccines in Clinical Developmentgp100:209-217(210M) (National Cancer Institute)
Lucanix (Belagenpumatucel-L) (NovaRx Corp.)
GVAX (BioSante Pharmaceuticals [formerly Cell GeneSys])
Stimuvax (Emepepimut-S) (Merck KGaA/Oncothyreon)
TroVax (MVA-5T4) (Oxford BioMedica)
GSK1572932A (GlaxoSmithKline)
Prostvac-VF/TRICOM (BN Immunotherapeutics)
OPT-822 (Optimer Biotechnology)
IMA901 (Immatics Biotechnologies GmbH)
GV1001 (KAEL-GemVax)
Candidates to Enter Phase III
TG-4010 (Transgene SA)
Rindopepimut (CDX-110) (Avant Immunotherapeutics)
Selected Phase I/II Candidate Vaccines
ONY-P (VaxOnco)
DPX-0907 and DPX-Survivac (Immunovaccine)
ADXS11-001 (Advaxis)
IDM-2101 (BioTech Synergy)
VGX-3100 (Inovio Pharmaceuticals)
SCIB1 (Scancell Holdings)
HyperAcute Vaccines (NewLinkGenetics Corp./Ochsner Health System)
PEP-223/CoVaccine HT (Pepscan Systems BV)
ImMucin (Vaxil BioTherapeutics)
GI-4000 and GI-6207 (GlobeImmune)
PEV-6A (Pevion Biotech and Bio Life Science)
4.4. Market Potential for Cancer Vaccines
Chapter 5
VACCINE PERSPECTIVES TO 2020
5.1. Bioinformatics, Simulations, and In Silico Vaccinology
5.2. Toward the "Universalization" of Vaccines?
5.3. The Future of Vaccine Patenting
5.4. Commercial Scenarios for Vaccines
5.5. Summary
References
Company Index