The Human Vaccines Project: Transforming the Future of Vaccine Development

Successful development of vaccines against the major global diseases for which vaccines do not currently exist would be transformational for public health, with huge benefits across society.  However, past strategies for vaccine development are unlikely to succeed in the future against major global diseases.  For such diseases, the correlates of protection are poorly understood, and the pathogens evade immune detection and/or exhibit extensive genetic variability. Limitations of animal models to predict human immune responses to vaccines, coupled with low success rates for vaccine development compared with biopharmaceuticals, suggest that new paradigms must be established for accelerating vaccine development.  The confluence of recent technological advances in vaccine discovery and immune monitoring provides a unique opportunity for accelerating next generation vaccine development, yet major scientific challenges and gaps in understanding human immune responses to candidate vaccines and human innate-adaptive signatures of protective immunity are impeding progress.  For example, immunization strategies required to induce human immune responses to subdominant protective epitopes remain unclear, as do optimal strategies for elicitation of long-term memory responses, or for driving somatic hypermutation and affinity maturation likely needed for induction of effective neutralizing antibody responses.  A “Human Vaccines Project” is being established in parallel to pathogen-specific product development programs, with the goal of significantly accelerating next generation vaccine development by solving the principal scientific challenges currently impeding progress. The “Human Vaccines Project” holds the potential to greatly accelerate the development of vaccines against major global killers such as AIDS, tuberculosis, malaria, and other infectious diseases; enable more successful vaccine development against allergies, autoimmune diseases, and cancers; and, provides a foundation for vaccine development against new and emerging diseases.