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.
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. The study's results will provide critical insights into TB vaccine strategies for aging populations, ensuring a foundation for broader preventative interventions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
144
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, Gyeonggi-do, South Korea
RECRUITINGYonsei University Severance Hospital
Seoul, South Korea
RECRUITINGThe Catholic University of Korea Seoul ST.MARY'S Hospital
Seoul, South Korea
RECRUITINGAjou University Hospital
Suwon, South Korea
RECRUITINGSafety Endpoint - Immediate Adverse Events
Immediate adverse events within 30 minutes after administration
Time frame: Within 30 minutes after each administration
Safety Endpoint - Solicited local and systemic Adverse Events
Solicited local/systemic AEs occurred up to 7 days after administration
Time frame: Occurred up to 7 days after each administration
Safety Endpoint - Unsolicited local and systemic Adverse Events
Unsolicited local/systemic AEs occurred up to 28 days after administration
Time frame: Occurred up to 28 days after each administration
Safety Endpoint - Serious Adverse Events and Adverse Event of of Special Interest
Serious AE (SAEs) and AE of special interest (AESI) occurred from the first administration up to 48 weeks after the last administration
Time frame: Occurred from the first administration up to 48 weeks after the last administration
Safety Endpoint - Laboratory assessment (Hematological Test)
Hematological test for each participant
Time frame: From screening to the end of visit at 48 weeks after the last administration
Safety Endpoint - Laboratory assessment (Hematochemical test)
Hematochemical test for each participant
Time frame: From screening to the end of visit at 48 weeks after the last administration
Safety Endpoint - Laboratory assessment (Urine test)
Urine test for each participant
Time frame: From screening to the end of visit at 48 weeks after the last administration
Safety Endpoint - Vital Signs (Body temperature)
Body weight will be measured at each scheduled visit after the administration of the investigational product for each participant.
Time frame: From screening to the end of visit at 48 weeks after the last administration
Safety Endpoint - Vital Signs (Pulse)
Pulse rate will be measured for each participant.
Time frame: From screening to the end of visit at 48 weeks after the last administration
Safety Endpoint - Vital Signs (Respiratory rate)
Respiratory rate will be measured for each participant.
Time frame: From screening to the end of visit at 48 weeks after the last administration
Safety Endpoint - Vital Signs (Blood pressure)
Systolic and diastolic blood pressure will be measured for each participant.
Time frame: From screening to the end of visit at 48 weeks after the last administration
Immunogenicity Endpoint - Humoral immunity (GMT)
Geometric mean titer (GMT) of antigen-specific IgG measured with ELISA
Time frame: Before 1st administration, 4 weeks after 1st administration, 4 weeks after 2nd administration, 4 and 48 weeks after 3rd administration
Immunogenicity Endpoint - Humoral immunity (GMFR)
Geometric mean fold rise (GMFR) of antigen-specific IgG measured with ELISA
Time frame: Before 1st administration, 4 weeks after 1st administration, 4 weeks after 2nd administration, 4 and 48 weeks after 3rd administration
Immunogenicity Endpoint - Humoral immunity (SRR)
Seroresponse rate (SRR), defined as a 4-fold rise in antibody titer of antigen-specific IgG measured with ELISA from Baseline
Time frame: Before 1st administration, 4 weeks after 1st administration, 4 weeks after 2nd administration, 4 and 48 weeks after 3rd administration
Immunogenicity Endpoint - Cellular immunity (ICS)
The ratio and amount of antigen-specific Th1 cytokine-secreting cells measured with intracellular cytokine staining (ICS)
Time frame: Before 1st administration, 4 weeks after 1st administration, 4 weeks after 2nd administration, 4 and 48 weeks after 3rd administration
Immunogenicity Endpoint - Cellular immunity (RR)
Cell response rate (RR), defined as a 4-fold rise in the amount of antigen-specific Th1 cytokine-secreting cells from the baseline.
Time frame: Before 1st administration, 4 weeks after 1st administration, 4 weeks after 2nd administration, 4 and 48 weeks after 3rd administration
Safety Endpoint - Physical examinations (General Appearance)
Overall health and appearance, including posture and obvious abnormalities.
Time frame: At screening, the second and third administrations, 4, 24 and 48 weeks after the last administration.
Safety Endpoint - Physical examinations (Skin)
Inspection for rashes, lesions, discoloration, or other visible skin issues
Time frame: At screening, the second and third administrations, 4, 24 and 48 weeks after the last administration.
Safety Endpoint - Physical examinations (Head/Neck)
Examination of the skull, scalp, lymph nodes, and thyroid gland
Time frame: At screening, the second and third administrations, 4, 24 and 48 weeks after the last administration.
Safety Endpoint - Physical examinations (Chest/Lungs)
Assessment of respiratory sounds, chest wall movement, and breathing patterns using inspection and auscultation
Time frame: At screening, the second and third administrations, 4, 24 and 48 weeks after the last administration.
Safety Endpoint - Physical examinations (Heart)
Evaluation of heart sounds, rhythm, and potential murmurs through auscultation and palpation
Time frame: At screening, the second and third administrations, 4, 24 and 48 weeks after the last administration.
Safety Endpoint - Physical examinations (Abdomen)
Palpation and auscultation for organ enlargement, tenderness, or abnormal bowel sounds
Time frame: At screening, the second and third administrations, 4, 24 and 48 weeks after the last administration.
Safety Endpoint - Physical examinations (Genitourinary System)
Examination of genital and urinary organs, focusing on abnormalities or patient-reported symptoms (if applicable)
Time frame: At screening, the second and third administrations, 4, 24 and 48 weeks after the last administration.
Safety Endpoint - Physical examinations (Limbs)
Inspection and assessment for swelling, deformities, or movement limitations
Time frame: At screening, the second and third administrations, 4, 24 and 48 weeks after the last administration.
Safety Endpoint - Physical examinations (Musculoskeletal System)
Examination of joints, muscles, and bones for pain, swelling, or restricted mobility
Time frame: At screening, the second and third administrations, 4, 24 and 48 weeks after the last administration.
Safety Endpoint - Physical examinations (Nervous System)
Assessment of reflexes, motor and sensory functions, and coordination
Time frame: At screening, the second and third administrations, 4, 24 and 48 weeks after the last administration.
Safety Endpoint - Physical examinations (Other)
Any additional assessments based on the participant's symptoms or clinical findings
Time frame: At screening, the second and third administrations, 4, 24 and 48 weeks after the last administration.
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