Development of a technological framework for using virus-like particles as adjuvants in prophylactic and therapeutic vaccines: demonstration of effect in animal models and humans

developing an effective vaccine entails: 1) proper antigenic presentation to the immune system, inducing a response of adequate intensity 2) a long duration for said response 3) the ability to steer this response towards the immune system pattern most suited for the elimination of the pathogen. among the current crop of adjuvants, only aluminum-based gels and some oil emulsions are compliant with established regulatory and safety requirements and, not surprisingly, have received extensive use. the present work describes the development of a technological framework for the inclusion of virus-like particles (vlp) as adjuvants in vaccine preparations, allowing the induction of a functional immune response in humans that achieves seroconversion and protective antibody levels without the need for additional adjuvants. this technological framework comprises both the production and formulation of antigens as virus-like particles and the use of these vlp as adjuvants for soluble antigens, obtaining high levels of induction of the th1 cell response which, in combination with the humoral response, have been shown to confer a fully functional immunoprotective status in animal models. some of the novel aspects of the present work are the development of a common methodology for the obtention and formulation of different vlp; the demonstration that vlp-containing formulations are able to bias response towards a th1 pattern; the finding that vlp can be used as adjuvants stimulating a fully functional response in humans to soluble antigens; the safety of vlp-adjuvanted formulations and, lastly, the induction of a functional, protective response in animal models and humans.