Abstract
Many vaccine candidates with promising results in preclinical testing fail in human trials. New complex human tissue models have the potential to improve the predictability of vaccine safety and efficacy in human clinical trials.
Highlights
Before being introduced into the market, potential vaccines must be assessed for toxicity, immunogenic response stimulated, efficacy, and public health impact. This phase of the vaccine development process is usually done with 2D in vitro cultures of human cell lines as well as animal models such as mice and small primates
Current advances in tissue engineering and cell biology have provided many tools for the development of complex in vitro 3D test systems relevant for studying human diseases and vaccine development
There is, an increasing interest in the potential impact of these models in the vaccine development process. This interest is reflected in the addition of the advanced human tissue models work package to the recently installed Inno4Vac consortium under the EU-funded Innovative Medicine Initiative (IMI), which is aimed at accelerating vaccine development and manufacture [7]
Summary
Vaccine development involves highly complex and expensive processes that have been classified by regulatory bodies into 2 stages: preclinical (in vitro and in vivo animal testing) and clinical (human). This phase of the vaccine development process is usually done with 2D in vitro cultures of human cell lines as well as animal models such as mice and small primates. Considerable physiological and immunological disparities exist between humans and animals while 2D human cell cultures lack the complexity of the in vivo tissue.
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