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Quratis

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[2018.01.02] Quratis, First Approves for Phase 2a Clinical Trials of adults Tuberculosis Vaccine in Korea
관리자|2018-01-02 Hit|779

Quratis, First Approval for Phase 2a Clinical Trials of adults Tuberculosis Vaccine in Korea

 

Consideration of phase 1 clinical trials for adolescents


Quratis announced on the 1st that it has obtained approval from the MFDS (Ministry of Food and Drug Safety) for the first time in Korea for a phase 2a clinical trial (IND;Investigational New Drug) of an adult tuberculosis vaccine.


This clinical trial was conducted at Yonsei Medical Center Severance Hospital.

Quratis' tuberculosis prevention vaccine for adults consists of antigens associated with the virulence and latency called ID93 and a TLR4 action-based synthetic immune adjuvant called GLA-SE, which induces TB-defensive cell mediated immunity through three muscle injection to adults with BCG in their infancy.

 

"We will evaluate the safety of TB vaccines for healthy adults for about a year and a half, and explore immunogenicity and efficacy." said Choi Yoo-hwa, director of clinical affairs at Quratis. " We plan to conduct clinical trials for phase 2b and phase 3 clinical trials in the future, and we are also considering phase 1 clinical trials for aldolescents in order to expand the target."

We will try to successfully carry out phase 2a clinical trials so that adult TB vaccines can be commercialized as soon as possible, said Kang Young-ae, a professor of respiratory medicine at Yonsei Medical Center Severance Hospital.