Team leader

Objectives of the team

The clinical research team aims to conduct clinical trials for the human application of new vaccines discovered by research teams of the core vaccine development center, perform integrated analysis of clinical and specimen analysis data, and use vaccines with high clinical usefulness and reduced adverse reactions in clinical practice.

Description of research and development by the team

The team strives toward the practical application of new vaccines during normal and emergency times through research and development based on investigator-initiated clinical trials and clinical specimen analysis.
The team analyzes clinical specimens using various molecular biological/immunological techniques to further understand host–pathogen interactions. Simultaneously, the immune responses of patients with infectious diseases and vaccine recipients are analyzed. This may lead to the development of vaccines with high utility and reduced adverse reactions through a cycle of translational and reverse translational research.
This team leads clinical studies (early-phase investigator-initiated clinical trials) wherein new vaccine candidates, including new modalities and drug delivery systems (DDS) designed by the teams at the core vaccine development center, are administered to humans for the first time. This team conducts clinical and immunological assessments of new vaccines in humans. This team provides the results for the next-phase confirmatory trials to facilitate the social implementation of new vaccines through industry–academia collaboration.

Tasks of the team

1. 1Elucidation of human immune response mechanisms for effective vaccine development
   • Constant collection of clinical information and specimens from patients with infectious diseases, vaccinated patients, and vaccinated healthy individuals
   • Analysis of human immune responses by state-of-the-art comprehensive analytical techniques, such as single-cell analysis, using clinical specimens collected after COVID-19 infection and vaccination
   • Immunological analysis before and after vaccination, focusing on immunological memory
   • Comparison of immune responses after mRNA vaccination in patients with altered immunity due to autoimmune diseases, cancer treatments, or other reasons with those in healthy individuals to identify factors affecting the efficacy of mRNA vaccines and susceptibility to infection
   • Establishment of prediction methods for clinical effects (benefits and adverse reactions) of vaccines via integrated analysis of specimen and clinical information using artificial intelligence
2. 2Clinical development of new vaccines with high efficacy and safety
   • Development of a clinical trial implementation system that is effective during both normal and emergency times
   • Collection of nonclinical data on novel vaccine candidates and preparation of investigator’s brochures
   • Preparation of clinical research-related documents, including protocols
   • Conducting investigator-initiated clinical trials of new vaccines
   • Clinical application of evaluation systems related to new vaccine candidates
   • Development of human resources familiar with clinical trials of vaccines