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

NCT03806686 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2019-05-31

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Access to Advanced Health Institute (AAHI)

    collaborator OTHER

  • Quratis Inc.

    lead INDUSTRY

Principal Investigators

  • Yu Hwa Choi · Quratis Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-31
Primary Completion
2020-03-31
Completion
2020-06-30
FDA Drug
Yes

Countries

  • South Korea

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03806686 on ClinicalTrials.gov