台灣臨床試驗資訊平台

TCTC for Pediatric Infectious Disease

Overview

TCTC

Children bear the heaviest burden of infectious illness. An island-wide or even international multi-institution collaboration is especially needed to accomplish any clinical trial in the field of pediatric infectious diseases. This is the grounds that we established the first Taiwan Pediatric Infectious Diseases Alliance (TPIDA) in 2009.

TPIDA, led by Professor Li-Min Huang of National Taiwan University Hospital, is a collaborative consortium of pediatric institutes in medical centers around the island. Since 2010, we together have already accomplished many joint researches regarding pediatric infectious diseases, and more studies about vaccine efficacy and effectiveness are on the way to establish Taiwan Pediatric Diseases Clinical Trial Consortium (TPDCTC).

Strengths

TCTC

This consortium has wide-ranging experiences of collaboration with local/ international research institutes/pharmaceutical companies and CDC to examine new diagnostic test, therapeutic drugs, or vaccines. We have conducted various clinical trials in the past few years, including antiviral small molecule, seroprevalence of diseases in Taiwanese children, the efficacy and effectiveness of vaccines against vaccine preventable diseases, the immunogenicity and safety of unlisted vaccines, pre-registration trial for new medical devices and detection kit, and the surveillance of pathogens for acute gastroenteritis.
Maintained the largest pediatric respiratory tract virus bank in Taiwan. Through the successful establishment of human airway epithelium cell culture (HAE), we could test the host-viral interaction and outcomes by using a more relevant ex vivo model.
Demonstrated extraordinary ability to perform nationwide clinical trials for pediatric infectious diseases in Taiwan. Our recruitment capacity has increased to hundreds of young children and very young infants for recent sponsored clinical trials outperforming many competing sites in other countries.
Holds a variety of educational symposia for researchers and clinicians to understand pediatric infectious diseases, especially in the field of viral infection.

Major Achievements

TCTC

International cooperation

‧ This alliance is entrusted by international pharmaceutical companies to conduct pre-market clinical trials of children's vaccines and early clinical trials of antiviral drugs, and also jointly publish research results after the trials.

‧ Alliance members also actively participate various international seminars related to children infectious diseases, and get the new knowledge from international pediatric infectious disease research. We also display research results to the international, attracting international research teams to propose cooperation plans and participate in global children's research.

‧ This alliance dispatches clinicians and clinical trial personnel to international early clinical trial institutions to study and receive long-term and short-term training. After returning from the training, clinicians also participated in the training course as a lecturer to cultivate more talents for early clinical trials of pediatrics in Taiwan.

Industry-University-Research Orientation

‧ This alliance has been assisting two domestic biotech manufacturers to conduct clinical trials of children's vaccines for a long time. To strengthen Taiwan's independent production capacity for vaccines, and increase vaccine options for infants and children.

‧ Assisted the phase III clinical trial of Taiwan Medigen Vaccine Biologics Corp.'s EV71 vaccine program. (A Phase III, multiple-center, double-blind, randomized, placebo-controlled study to evaluate the efficacy, immunogenicity, and safety of an adjuvanted inactivated Enterovirus 71 vaccine in healthy infants and children; NCT05099029). This research was published in the journal of Lancet.

‧ Assisted the phase II clinical trial of Taiwan Medigen Vaccine Biologics Corp.'s COVID-19 vaccine. (Phase II, prospective, double-blinded, multi-center study to evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 vaccine candidate MVC-COV1901 in adolescents; NCT04951388). This research was published in the journal of medRxiv.

Social aspects

‧ Through the research teams of medical centers in various districts across the Taiwan, the Alliance establish the local epidemiological data on infants and children. The results will be used as an important reference for government policy formulation and disease prevention in future works.

‧ The COVID-19 virus is constantly mutating, threatening the health of the people. We will continue to assist domestic manufacturers in the development of new COVID-19 vaccines, and hope to protect the people health.

Economic aspects

‧ The Medigen Vaccine Biologics Corp.'s enterovirus 71 (EV71) vaccine program has passed the phase III of clinical trials. If it is successfully launched in the future, it will be bring great economic benefits.

‧ Continue to assist Medigen Vaccine Biologics Corp. to complete and execute clinical trials related to COVID-19 vaccines. COVID-19 is expected to become a seasonal illness like most respiratory viruses. To prevent COVID-19, it could be need vaccinate every year in the future. High safety and broad protection will be the main development direction of the new COVID-19 in the future. If the clinical trial is successful, it will help the subsequent economic benefits will be considerable.