Tuberculosis Clinical Trial
Official title:
A Phase 1, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety and Explore the Immunogenicity of ID93+GLA-SE Vaccine in BCG-Vaccinated Healthy Adolescent
The purpose of this study is to evaluate safety, immunogenicity of ID93+GLA-SE compared to placebo following three intramuscular (IM) injections on Days 0, 28 and 56 in BCG-vaccinated QFT-negative healthy adolescent. The healthy adolescent 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 and immunogenicity tests. The study hypothesis is that the vaccine is safe and immunogenic in this study population.
After signing a written informed consent to participate in the study(under the premise the
legal representative also agree their children 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 of the Investigational Product in the
subjects through-out 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 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
unsolicited 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 will be collected and analyzed before and after
each vaccination. QFT-Gold Plus testing will be performed after 1 month and 12 months from
the final vaccination with the Investigational Product.
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