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Phase 1 Clinical Trial of Single-Vial ID93 + GLA-SE in Healthy Adults

NCT03722472 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-06-01

Study results available
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Summary

This is a phase 1, double-blind, randomized clinical trial to evaluate the safety, tolerability, and immunogenicity of single-vial lyophilized ID93 + GLA-SE compared to the two-vial presentation consisting of lyophilized ID93 and liquid GLA-SE administered as two IM injections in healthy adult subjects (aged 18 - 55).

Conditions

  • Pulmonary TB

Interventions

BIOLOGICAL

ID93 + GLA-SE

The single-vial lyophilized vaccine will be reconstituted with WFI. For the two-vial presentation, the lyophilized ID93 will be reconstituted with WFI and mixed with liquid GLA-SE.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Access to Advanced Health Institute (AAHI)

    lead OTHER

Principal Investigators

  • Christopher Fox, PhD · Access to Advanced Health Institute (AAHI)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-02
Primary Completion
2020-06-15
Completion
2020-06-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03722472 on ClinicalTrials.gov