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The Effects of GLA (5 mcg) on Human Volunteers

NCT01864876 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2014-02-26

No results posted yet for this study

Summary

This protocol is for a phase 1, randomized, single-blinded study to evaluate the safety and tolerability of a single 5 mcg dose of GLA-SE administered intramuscularly and GLA-AF administered subcutaneously. The second focus will be to detail the global immune response by measuring systemic cytokines, chemokines, and global gene regulation. The third focus will be to investigate the effects of GLA on the peripheral blood immune cells including monocytes and dendritic cells. The results of this trial will generate supportive human data to use GLA as an adjuvant in a dendritic cell-targeted vaccine strategy.

Conditions

  • Healthy Volunteers

Interventions

BIOLOGICAL

GLA-AF

Glucopyranosyl Lipid A (GLA) in an aqueous formulation (AF).

BIOLOGICAL

GLA-SE

Glucopyranosyl Lipid A (GLA) in a stable oil-in-water emulsion (SE).

BIOLOGICAL

EM060G (SE)

The same stable oil-in-water emulsion (SE), but without GLA.

Sponsors & Collaborators

  • Rockefeller University

    collaborator OTHER

  • Access to Advanced Health Institute (AAHI)

    lead OTHER

Principal Investigators

  • Franco Piazza, MD, MPH · Access to Advanced Health Institute (AAHI)

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-12-31
Completion
2013-12-31

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 NCT01864876 on ClinicalTrials.gov