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RECRUITING
NCT06714513
PHASE1

ID93+GLA-SE Vaccine Against Tuberculosis in Older Adults Aged 55-74

Sponsor: Quratis Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety and explore the immunogenicity of ID93+GLA-SE compared to placebo following three intramuscular (IM) injections on Days 0, 28 and 56 in the Bacillus Calmette-Guérin (BCG)-vaccinated older adults aged 55 to 74 with negative or positive result on the QuantiFERON-TB (QFT) test. Eligible participants will be randomly assigned based on age group and the QFT test results to receive either QTP101 (Dose 1 and Dose 2) or placebo. Safety and immunogenicity will be monitored from the first dose until 12 months after the final dose of the investigational product. Blood samples for immunogenicity analysis will be collected at five-time points: before the first dose (Day 0), 4 weeks after the first dose (Day 28), 4 weeks after the second dose (Day 56), 4 weeks after the third dose (Day 84), and 48 weeks after the third dose (Day 392). Once the safety and immunogenicity follow-up is completed 48 weeks after the third dose (Day 392) for the last enrolled participant, a final report will be compiled based on the collected data.

Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Explore the Immunogenicity of the Tuberculosis (TB) Vaccine Candidate QTP101 (ID93+GLA-SE) in Older Adults (Aged 55~74 Years)

Key Details

Gender

All

Age Range

55 Years - 74 Years

Study Type

INTERVENTIONAL

Enrollment

144

Start Date

2025-05-09

Completion Date

2026-12

Last Updated

2025-06-17

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

QTP101

QTP101 consists of ID93 and GLA-SE. ID93 is a recombinant protein antigen comprising four antigens from Mycobacterium tuberculosis (Mtb). The adjuvant GLA-SE is a TLR4 agonist in a stable oil-in-water emulsion.

BIOLOGICAL

Placebo

Sterile 0.9% normal saline

Locations (4)

Chung-Ang University Gwangmyeong Hospital

Gwangmyeong, Gyeonggi-do, South Korea

Yonsei University Severance Hospital

Seoul, South Korea

The Catholic University of Korea Seoul ST.MARY'S Hospital

Seoul, South Korea

Ajou University Hospital

Suwon, South Korea