ID93+GLA-SE Vaccine Against Tuberculosis in Older Adults Aged 55-74
Trial Parameters
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.
Eligibility Criteria
Inclusion Criteria: 1. Participants who can comply with all scheduled assessment visits during the clinical trial period and who can be continuously monitored by the investigator through the provided contact information 2. Males or females aged 55 to 74 years at the time of consent 3. Participants and/or legally authorized representatives who are capable of providing written informed consent (signed in person in the presence of a witness) 4. Participants with either positive or negative QFT test results at the time of screening; QFT testing can be omitted in the following case: If participants have a documented history of a positive QFT test result, evidenced by submitted records or recorded in the EMR 5. Participants with negative HIV test results at the time of screening 6. Participants with a record of BCG vaccination or BCG scar directly 7. Participants who fall within the following range in physical measurements at the time of screening: 19 ≤ Body Mass Index (BMI) ≤ 33 (kg/m\^2) B