NCT03806699

Phase 1 Clinical Trial of ID93+GLA-SE Vaccine in BCG-vaccinated Healthy Adolescent

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Quratis Inc. · Industry
• Sex: All
• Age: 14 Years – 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
BIOLOGICAL	Placebo	Sterile normal saline
BIOLOGICAL	ID93+GLA-SE	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.

Timeline

• Start date: 2019-04-02
• Primary completion: 2020-09-01
• Completion: 2020-12-01
• First posted: 2019-01-16
• Last updated: 2019-07-23

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study