The purpose of this study is to evaluate the experimental tuberculosis (TB) vaccine called ID93+GLA-SE. The safety, immunogenicity, and efficacy of ID93+GLA-SE will be compared to placebo, after three intramuscular (IM) injections one month apart in healthy healthcare workers. The healthcare workers will all have had the childhood TB vaccine called BCG, and all of them must have a negative result for a blood test for exposure to the bacteria that cause TB (QuantiFERON-TB Gold Plus, or "QFT"). Study participants will be followed for 12 months after the last injection for safety reasons. Blood will be drawn for laboratory tests for safety, immunogenicity, and efficacy tests. Efficacy will be evaluated by further QFT testing. The study hypothesis is that the vaccine is safe, immunogenic, and effective in this study population.
After signing a written informed consent to participate in the study, subjects will be screened by required assessments per protocol. Eligible subjects who meet the inclusion/exclusion criteria will be randomized in a 1:1:1 ratio to Group 1, Group 2, or Control Group, receiving either ID93+GLA-SE or saline placebo on Days 0, 28, and 56. The investigator will evaluate the safety, immunogenicity, and efficacy of the Investigational Product in the subjects throughout the study. For safety assessment, subjects will be instructed to record any adverse events in the subject diary after each vaccination. Subject's safety will be reported to the investigators after 7 days from each vaccination (Days 7, 35, 63) via site visit or a phone call. Solicited AEs will be collected up to 7 days after the final vaccination with the Investigational Product and un-solicited AEs will be collected up to 28 days after the final vaccination with the Investigational Product. For long-term safety assessment of the Investigational Product, serious adverse events and adverse events of special interest will be monitored up to 12 months after the final vaccination with the Investigational Product. For immunogenicity assessment, blood samples for immunology assays will be collected and analyzed before and after each vaccination. For efficacy assessment, QFT-Gold Plus testing will be performed after 3 months and 14months from the first vaccination with the Investigational Product.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
107
Sterile normal saline
ID93 is a recombinant protein antigen comprising 4 antigens from Mycobacterium tuberculosis (Mtb). The adjuvant GLA-SE is a TLR4 agonist in a stable oil-in-water emulsion.
Ajou University Hospital
Gyeonggi-do, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Chung-Ang University Hospital
Seoul, South Korea
Adverse events
Solicited (local and systemic reactogenicity), unsolicited (all other adverse events, including laboratory assessments and vital signs), serious AEs and AEs of special interest.
Time frame: Solicited AEs for 7 days following each injection, unsolicited AEs for 28 days after each injection, SAEs and AESIs for 12 months after the last injection.
Humoral and cellular immunogenicity assays
Immunogenicity will be evaluated by measuring humoral and cellular responses to ID93 + GLA-SE at specified timepoints
Time frame: Days 0, 28, 56, 84, and 12 months after last injection.
Efficacy at prevention of latent Mtb infection (QFT conversion)
Positive response rate for latent tuberculosis infection from QuantiFERON®-TB Gold Plus assay.
Time frame: 3 months and 14 months after the first injection.
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