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

NCT06714513 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2025-06-17

No results posted yet for this study

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.

Conditions

  • Tuberculosis, Pulmonary

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

Sponsors & Collaborators

  • Quratis Inc.

    lead INDUSTRY

Principal Investigators

  • Jinhee Lee, DVM, PhD · Quratis Inc.

  • Jae Chol Choi, MD, PhD · Chung-Ang University Gwangmyeong Hospital

  • Youngmok Park, MD, PhD · Severance Hospital

  • Kwang Joo Park, MD, PhD · Ajou University School of Medicine

  • Jinsoo Min, MD, PhD · The Catholic University of Korea

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-09
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • South Korea

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06714513 on ClinicalTrials.gov