Phase 2a Clinical Trial of ID93+GLA-SE Vaccine in BCG-vaccinated Healthy Healthcare Workers

Tuberculosis Clinical Trial

Official title: A Phase 2a, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety and Explore the Immunogenicity and Efficacy of ID93+GLA-SE Vaccine in BCG-Vaccinated Healthy Healthcare Workers

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Tuberculosis

• NCT number: NCT03806686
• Study type: Interventional
• Source: Quratis Inc.
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 31, 2018
• Completion date: June 2020