Quratis to Start Clinical Research on Youth Tuberculosis Vaccines
1 phase clinical IND additional approval
Quratis Inc., which started out as an in-school venture at Yonsei Medical Center, will begin clinical research on tuberculosis vaccines for teenagers.
Quratis recently said it has obtained additional approval from the Ministry of Food and Drug Safety for the first time in Korea to plan a first-phase clinical trial of a vaccine against tuberculosis for teenagers to expand the number of subjects.
The first phase of the test will evaluate the safety of tuberculosis vaccines and explore immunological sources for about a year and a half for teenagers. It will be carried out at Hallym University Chunchunseongsim Hospital and has obtained approval for the initial report from the hospital's Clinical Test Ethics Committee.
Quratis previously obtained approval from the Ministry of Food and Drug Administration for a two-a-phase clinical trial of a vaccine against tuberculosis for adults in December 2017. The study is being conducted at Yonsei Medical Center Severance Hospital, Ajou University Hospital, and Chung-Ang University Hospital. It will evaluate the safety of TB vaccines for healthy adults and adolescents and explore immunological origin and efficacy and plans to conduct two-b phase clinical trials and three-phase clinical trials in stages in the future.
The tuberculosis vaccine in question consists of an antigen related to pathotoxicity and latent infection of tuberculosis bacteria called ID93 and a TLR 4 agonist-based synthetic immunosuppressant called GLA-SE.
Three muscle injections are given to adolescents and adults who were vaccinated against BCG within four weeks of birth to induce mediated immunization of TB-defensive cells.
Meanwhile, Quratis is currently developing a number of vaccines and treatments for infectious disease and is set to launch a current Good Manufacturing Practice (CGMP) plant in Osong, North Chungcheong Province, in March to manufacture tuberculosis vaccines and immunosuppressants.
