Quratis, Added Clinical Approval for Young Tuberculosis Vaccine

Safety and immunological assessment scheduled for 1 1/2 years


Quratis Inc., a corporation, said on Dec. 11 last year that it has obtained additional approval from the Food and Drug Administration for the first time in Korea for a one-phase clinical trial plan for a vaccine against tuberculosis for young people to expand its target.

The first phase of the vaccine against tuberculosis for teenagers will evaluate the safety of the vaccine for tuberculosis for about a year and a half and explore its immunological source for young people. This will be carried out at Hallym University's Chunchunseongsim Hospital and has obtained the approval of the initial report from the hospital's Clinical Test Ethics Committee.

Earlier on December 19, 2017, Quratis obtained the approval of a 2a-phase clinical trial of a vaccine against tuberculosis for adults for the first time in Korea, and the clinical trials are being conducted at Yonsei Medical Center Severance Hospital, Ajou University Hospital, and Chungang University Hospital.

Clinical trials will evaluate the safety of TB vaccines for healthy adults and adolescents and explore immunological origin and efficacy and plan to stage two-b phase clinical trials and three-phase clinical trials in the future.

The TB vaccine consists of an antigen of the tuberculosis bacterium called ID93 and a TLR 4 agonist-based synthetic immunosuppressant called GLA-SE, which induces the TB-defensive cell-mediated immunity by injecting young adults and adults who were vaccinated against BCG within four weeks of birth.

Meanwhile, Quratis started as an in-school venture at Yonsei Medical Center on July 15, 2016, and is currently developing a number of infectious diseases vaccines and treatments, as well as tuberculosis vaccines, and is set to launch a CGP (cGMP) plant for the manufacture of tuberculosis vaccines and immunosuppressants in Osong, North Chungcheong Province, in March.