ID93+GLA-SE Vaccine Against Tuberculosis in Older Adults Aged 55-74
brief 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.
detailed description
This Phase 1 randomized, double-blind, placebo-controlled clinical trial aims to evaluate the safety and explore the immunogenicity of the investigational tuberculosis (TB) vaccine candidate QTP101 (ID93+GLA-SE) in healthy and medically stable older adults aged 55-74 years. The study targets two specific age groups-55-64 years (middle-aged) and 65-74 years (elderly)-to address the unmet need for effective TB prevention in populations with high disease prevalence and risk, particularly in countries with an aging population.
The trial involves three treatment arms:
Low-dose vaccine group: 2 μg ID93 + 5 μg GLA-SE High-dose vaccine group: 10 μg ID93 + 5 μg GLA-SE Placebo group: Normal saline (0.9%)
Participants will receive three intramuscular (IM) injections of their assigned treatment at baseline (Day 0), Day 28, and Day 56. They will be monitored for safety and immunogenicity over 12 months, with regular follow-up visits scheduled at 1, 6, and 12 months post-final injection.
Key Study Elements:
Eligibility Criteria: Participants must be BCG-vaccinated, HIV-negative, and have QuantiFERON-TB Gold (QFT) test results positive or negative. Chronic conditions are permissible if well-controlled. Women of childbearing potential and men must use approved contraception methods during the study.
Safety Monitoring: Adverse events (AEs) will be closely monitored, categorized as immediate AEs (within 30 minutes of vaccination), solicited local/systemic AEs (within 7 days), unsolicited AEs (up to 28 days), and serious AEs (SAEs) monitored until 12 months post-final dose.
Immunogenicity Assessments: Blood samples will be collected pre-vaccination and at multiple intervals (Day 28, 56, 84, and 392) to measure ID93-specific antibody titers (ELISA) and Th1 cytokine responses (ICS).
Sentinel Design for Older Adults: To ensure participant safety, a sentinel group design is employed for cohorts aged 65-74. Initial vaccination will proceed sequentially within smaller sentinel subgroups, with further cohort enrollment contingent on DSMB approval after reviewing safety data.
Study Objective:
This trial aims to establish the safety profile and preliminary immunogenicity of QTP101 as a step toward addressing the persistent global burden of TB, particularly in vulnerable older populations. The results will inform subsequent clinical development phases to optimize the vaccine's dosing and application.
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)